Form pre-ted

Stem Cell Therapeutic Outcomes Database

2400-Pre-TED-080409-r2

Stem Cell Therapeutic Outcomes Database (Pre-TED)

OMB: 0915-0310

Document [pdf]
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Pre-Transplant Essential Data
CENTER IDENTIFICATION

930. CIBMTR Center # ___________EBMT Code (CIC)931.
________________
932. Hospital: _________________________________________________
933. Unit (circle one)*: A H O P Other, specify:933a.
___________________

HSCT (continued)

29.

* Abbreviations, see next page

934. Contact person (first name): __________________________________
935. (last name): ______________________________________________
938. Date of This Report___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

CIBMTR USE ONLY
Report Form due?
Yes
No
Reg only
901. Date Received:____________________________ DE:_____________

940.
951.
954.
955.
956.
942.

RECIPIENT IDENTIFICATION
CIBMTR recipient ID#: ______________________________________
ID assigned by:
CIBMTR
EBMT
Other952.
__________________
BMT-CTN, St ID #:_______
RCI-BMT, St ID #:_______ NMDP SCTOD
953.
Consented for Research?
Yes
No
Yes
No
Consented for CIBMTR Related Specimen Repository?
Gender: Male Female DOB:___
941. ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

Optional for non-US centers:
957. Ethnicity:
Hispanic or Latino
Not Hispanic or Latino
958. Race (check all that apply):
White
Black/African American
Asian
American Indian/Alaska Native
Native Hawaiian/Other Pacific Islander
DISEASE CLASSIFICATION
Complete and attach only the relevant Disease Classification Sheet
with date and status at transplantation:

1. Indicate broad disease for which HSCT was performed: (see Q.177)

AML {10}
Other disease {900}
ALL {20}
Other malignancy {200}
Other Acute Leukemia {80}
SAA {300}
CML {40}
Inherited Abnormalities of
MDS/MPS {50}
Erythrocyte Diff or Function {310}
Other Leukemia {30}
Platelet Disorder {500}
Hodgkin Lymphoma {150}
Histiocytic Disorders {570}
Non-hodgkin Lymphoma {100}
IDOM/Osteopetrosis {520}
Plasma Cell Disorders {170}
Immune Deficiency {400}
Breast Cancer {250}
Autoimmune {600}g
2. Date of diagnosis of primary disease for HSCT:
___ ___ ___ ___ - ___ ___ - ___ ___

30.
31.
32.
34.
35.
36.

Was there Ex vivo Graft Manipulation other than for RBC removal or
Yes
No
volume reduction?
(Check all that apply) Optional for non-U.S. Centers
T-cell depletion
Tumor purging
Other negative selection, specify: 33.
________________________
CD34 selection
ex vivo expansion
Other, specify: 37.
_______________________________________

38. Performance Score pre-Preparative Regimen:
20
30
40
50
60
70
39. 10

Karnofsky
Lansky
80
90
100

CMV-antibodies (IgG or Total) (Multiple donors: report any positive CMV test as reactive)
reactive non-reactive unknown not done
40. Recipient:
41. Donor (allo only):
PREPARATIVE REGIMEN

42. Was a preparative regimen given?

43.
45.
47.
51.

58.
60.

63.
65.
67.
69.
YYYY
MM
DD
71.
HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
73.
3. Date of this HSCT: ___ ___ ___ ___ - ___ ___ - ___ ___
75.
YYYY
MM
DD
77.
4. Chronological number of this HSCT: ________
79.
81.
If >1, most recent previous HSCT:
83.
Date of This5.
RDate::___ ___ ___ ___ - ___ ___ - ___ ___
85.
YYYY
MM
DD
87.
Date of This6.
RType:
Auto
Allo
Institution where previous HSCT was performed if different from current: 89.
7. Name: __________________________________________________
8. City: _________________________________9.State: _____________
10. Country: _________________________________________________
Cell source for this HSCT (check all that apply): 11. BM, 12. PBSC,
13. UCB 14. multiple CB units 15. Other:____ 16. Specify cell source: ____

Yes
No – skip to page 2
What was the total prescribed cumulative dose for the preparative
regimen (per the protocol)?
RAD unit Total Prescribed Dose
(Check all that apply)
cGy Gy
mg/m2 mg/kg
TBI ..............................
44. ___ ___ ___ ___
TLI, TNI, TAI ................
46. ___ ___ ___ ___
ALG, ALS, ATG, ATS (before d0)............
48.___ ___ ___ ___
Rabbit
Other, specify:____________
49. Horse
50.
anthracycline
52. daunorubicin ......................................
53.___ ___ ___ ___
54. doxorubicin ........................................
55.___ ___ ___ ___
56. idarubicin ...........................................
57.___ ___ ___ ___
bleomycin ...............................................
59.___ ___ ___ ___
busulfan ..................................................
61.___ ___ ___ ___
IV
Both
62. Oral
64.___ ___ ___ ___
carboplatin ..............................................
carmustine (BCNU) ................................
66.___ ___ ___ ___
68.___ ___ ___ ___
cisplatin ..................................................
corticosteroids ........................................
70.___ ___ ___ ___
cyclophosphamide ..................................
72.___ ___ ___ ___
cytarabine (Ara-C) ..................................
74.___ ___ ___ ___
etoposide (VP-16) ..................................
76.___ ___ ___ ___
fludarabine ..............................................
78.___ ___ ___ ___
ifosfamide ...............................................
80.___ ___ ___ ___
imatinib mesylate (Gleevec, Glivec) .............
82.___ ___ ___ ___
lomustine (CCNU) ..................................
84.___ ___ ___ ___
melphalan (L-PAM) .................................
86.___ ___ ___ ___
mitoxantrone ...........................................
88.___ ___ ___ ___
monoclonal antibody (MAb)g
90. Campath ............................................
91.___ ___ ___ ___
92. Rituximab (Rituxan, anti-CD20)...........
93.___ ___ ___ ___
94. Gemtuzumab (Mylotarg, anti-CD33) .....
95.___ ___ ___ ___
96. Other MAb .........................................
97.___ ___ ___ ___
98.specify:_____________________

series of collections shouldbe considered a single product when they are all
Donor Type: A
from the same donor & use the same collection method & technique (& mobiliza-

99.
paclitaxel (Taxol, Xyotax) ........................
100.___ ___ ___ ___
101.
teniposide (VM26) ..................................
102.___ ___ ___ ___
#
of
products:_______
18.
Autologous (self),
thiotepa ...................................................
103.
104.___ ___ ___ ___
20.
Multiple donors, # of donors:_______
105.
other, specify:______________
.............
106.___ ___ ___ ___
107.
To report more than one donor, 108.
Donor Gender:
NMDP
radiolabeled MAb ................................................ units mCi MBq
copy Qs21-28 and complete for
21. Male22. Female
each donor. Check here if
109. Tositumomab (Bexxar) .................................___
110. ___ ___ . ___
23.Allogeneic:
Syngeneic (monozygotic twin) additional pages are attached.
111. Ibritumomab (Zevalin) ..................................___
112. ___ ___ . ___
HLA-identical sibling (may include non-monozygotic twin)
114. ___ ___ . ___
113. Other rMab ...................................................___
HLA-matched other relative
115.specify:_____________________
HLA-mismatched relative
Yes NoP

17.
19.

24.

tion, if applicable), even if the collections are performed on different days.

Degree of mismatch:

1 HLA antigen mismatch
≥ 2 HLA antigen mismatch (full Haploidentical)

Unrelated donor (complete # of mismatches on HLA lines)
Registry or UCB Bank (BMDW code):

25. __ __ __ __
A
B
C
27. __ __ __
28. __ __ __

DRB1
__
__

Other, specify:

26. _______________________

DQB1 DPB1
__
__ Antigenic (2 digits)
__
__ Allelic (4 digits)

0=matched; 1=one mismatch; 2=2 mismatches; ND=not done

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

116. Is the INTENT of the preparative regimen MYELOABLATIVE (allo
only)?

Yes

No, reason for NST/RIC (check all that apply):

117. Age of recipient
118. Comorbid conditions
119. Prior HSCT
120. Protocol-driven
121. Other, specify:122.
_____________________________

US OMB Control No. 0915-0310, Expiration Date: 10/31/2010

Pre-TED# (8/04/09) Page 1 of 10

OMB No: 0915-0310
Expiration Date: 10-31-2010
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The OMB control number for
this project is 0915-0310. Public reporting burden for this collection of information is estimated to average 0.85
hours per response, including the time for reviewing instructions, searching existing data sources, and completing
and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer,
5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857.

Pre-Transplant Essential Data
CIBMTR Center #:

CIBMTR Recipient ID#:
This section is optional for non-U.S. Centers
COMORBID CONDITIONS

Yes
123. Is there a history of mechanical ventilation?
124. Is there a history of proven invasive fungal infection?

No
Yes

No

Were there clinically significant co-existing disease or organ impairment at time of patient assessment prior to preparative regimen?
125. Yes
No 'Allo' continue with Q145 below, 'auto' continue with Q163 below
Yes No NotDone Comorbidity

126.
127.
128.
129.
130.
131.
132.
133.
134.
135.
136.
137.
138.
139.
140.
141.
142.
143.

Definitions

Arrhythmia
Atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmias
Cardiac
Coronary artery disease §, congestive heart failure, myocardial infarction, or EF ≤ 50%
Cerebrovascular disease
Transient ischemic attack or cerebrovascular accident
Diabetes
Requiring treatment with insulin or oral hypoglycemics but not diet alone
Heart valve disease
Except mitral valve prolapse
Hepatic, mild
Chronic hepatitis, bilirubin > ULN to 1.5 × ULN, or AST/ALT > ULN to 2.5 × ULN
Hepatic, moderate/severe
Liver cirrhosis, bilirubin > 1.5 × ULN, or AST/ALT > 2.5 × ULN
Infection
Requiring continuation of antimicrobial treatment after day 0
Inflammatory bowel disease
Crohn's disease or ulcerative colitis
Obesity
Patients with a body mass index > 35 kg/m2
Peptic ulcer
Requiring treatment
Psychiatric disturbance
Depression or anxiety requiring psychiatric consult or treatment
Pulmonary, moderate
DLco and/or FEV1 66-80% or dyspnea on slight activity
Pulmonary, severe
DLco and/or FEV1 ≤ 65% or dyspnea at rest or requiring oxygen
Renal, moderate/severe
Serum creatinine > 2 mg/dL or >177 μmol/L, on dialysis, or prior renal transplantation
Rheumatologic
SLE, RA, polymyositis, mixed CTD, or polymyalgia rheumatica
Solid tumor, prior
Treated at any time point in the patient's past history, excluding nonmelanoma skin cancer
144. Specify:__________________________________________________________________
Other

§ One or more vessel-coronary artery stenosis requiring medical treatment, stent, or bypass graft.
EF indicates ejection fraction; ULN, upper limit of normal; SLE, systemic lupus erythmatosis; RA, rheumatoid arthritis; CTD, connective tissue disease; DLco, diffusion capacity of carbon monoxide.

Source: Blood, 2005 Oct 15;106(8):2912-2919

GVHD PROPHYLAXIS (ALLO ONLY)

Box A

145. Was GVHD prophylaxis planned/given?

Yes

Box B POST-HSCT DISEASE THERAPY PLANNED AS OF DAY 0

163. Is this HSCT part of a planned multiple (sequential) graft/HSCT

No

protocol?

(Check all that apply)

146.
147.
148.
149.
150.
151.
152.

159.
160.
161.

ALG, ALS, ATG, ATS (after d0)
Corticosteroids
Cyclosporine (CSA)
ECP (extra-corporeal photopheresis)
FK 506 (Tacrolimus, Prograf)
Methotrexate (MTX)
in vivo monoclonal antibody (MAb)
153.
Anti CD25 (Zenapax, Daclizumab, AntiTAC)
154.
Campath
155.
Etanercept (Enbrel)
156.
Infliximab (Remicade)
Other, specify:_____________________________________
157.
158.
Mycophenolate (MMF, Cellcept)
Sirolimus (Rapamycin, Rapamune)
Other drug, specify:____________________________________
162.

* Abbreviations
YYYY
MM
DD
AHOP
ALLO
ANC
AUTO
BM
BMT-CTN

=
=
=
=
=
=
=
=
=

CIBMTR =
CIC
CMV
CR
D

=
=
=
=

4 digit year
2 digit month
2 digit day
Adult, Hematology, Oncology or Pediatric Unit
Allogeneic
Absolute Neutrophil Count
Autologous
Bone Marrow
Blood & Marrow Transplant
Clinical Trials Network
Center for International Blood &
Marrow Transplant Research
Center Identification Code
Cytomegalovirus
Complete Remission
Disorders

DCI
DF
DLI
DOB
EBMT
EBV
FACT
FGF
FISH
GVHD
HSCT
IA
IDOM
KGF
NMDP
NOS

=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=

Yes

Yes

No

(Check all that apply) Optional for non-U.S. centers
165. bortezomib (Velcade)
166. Cellular therapy (e.g. DCI, DLI)
167. Intrathecal Chemotherapy
168. imatinib mesylate (Gleevec, Glivec)
169. lenalidomide (Revlimid)
170. Local radiotherapy
171. rituximab (Rituxan, Mabthera)
172. thalidomide (Thalomid)
173. Other, specify:________________________________________
174.
OTHER TOXICITY MODIFYING REGIMEN
Optional for non-U.S. Centers
175. Was KGF (palifermin, Kepivance) started or is there a plan to use it?
Yes
No
Masked trial
176. Was FGF (velafermin) started or is there a plan to use it?
Yes
No
Masked trial

Donor Cellular Infusion
Differentiation or function
Donor Lymphocyte Infusion
NST
Date of Birth
PBSC
European Group for Blood & Marrow Transplantation
PTLD
Epstein Barr Virus
RBC
Foundation for the Accreditation of Cellular Therapy
RCI-BMT
Fibroblast Growth Factor
RIC
Fluorescent In-situ Hybridization
SAA
Graft versus Host Disease
SCTOD
Hematopoietic Stem Cell Transplant
TBI, TLI, TNI
Inherited Abnormalities
U
Inherited Disorders of Metabolism
UCB
Keratinocyte Growth Factor
Unit
National Marrow Donor Program
VOD
Not Otherwise Specified

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

No

164. Is additional post-HSCT therapy planned?

=
=
=
=
=
=
=
=
=
=
=
=
=

Non-myeloablative Stem Cell Transplant
Peripheral Blood Stem Cells
Posttransplant lymphoproliferative disorder
Red Blood Cell
Resource for Clinical Investigations in Blood & Marrow Transplant
Reduced Intensity Conditioning
Severe Aplastic Anemia
Stem Cell Therapeutic Outcomes Database
Total (Body, Lymphoid, Nodal) Irradiation
Unclassifiable
Umbilical Cord Blood
Adult, Hematology, Oncology, Pediatric (AHOP)
Veno-occlusive disease

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:

ACUTE LEUKEMIAS
Select most specific W.H.O. classification:
177. Acute Myelogenous Leukemia (AML) (10) 177. Acute Lymphoblastic Leukemia (ALL) (20)177. Acute Leukemias of ambiguous lineage (80)
190. Precursor B-cell ALL {L1/L2} (191)
197. Acute undifferentiated leukemia (31)
AML with recurrent genetic abnormalities
Biphenotypic, bilineage or hybrid
178. AML with t(8;21)(q22;q22), (AML1/ETO) (281) If known, indicate subtype:
leukemia (32)
AML with abnormal BM eosinophils and
t(9;22)(q34;q11); BCR/ABL+ (192)
Acute mast cell leukemia (33)
t(v;11q23); MLL rearranged (193)
inv(16)(p13q22) or t(16;16)(p13;q22),
Other acute leukemia, (89)
t(1;19)(q23;p13) E2A/PBX1 (194)
(CBFβ/MYH11) (282)
APL with t(15;17)(q22;q12), (PML/RARα)
t(12;21)(p12;q22) ETV/CBF-α (195) 198. specify:___________________
Precursor T-cell ALL (196)
and variants/{M3} (283)
AML with 11q23 (MLL) abnormalities (284)
ALL, NOS (190)
AML with multilineage dysplasia (285)

AML, not otherwise categorized/{NOS}
AML, minimally differentiated/{M0} (286)
AML without maturation/{M1} (287)
AML with maturation/{M2} (288)
Acute Myelomonocytic Leukemia/{M4} (289)
Acute Monoblastic/Acute Monocytic
Leukemia/{M5} (290)
Acute Erythroid Leukemia (erythroid/
myeloid and pure erythroleukemia)/{M6} (291)
Acute Megakaryoblastic Leukemia/{M7} (292)
Acute Basophilic Leukemia (293)
Acute Panmyelosis with Myelofibrosis (294)
Myeloid Sarcoma (295)
AML, NOS (280)

179. Did AML transform from MDS or MPS?

Yes

No

Yes

No

Complete entire MDS Section on Disease Classification
page 4 and entire AML Section

180. Was AML therapy related?

Unknown

AML, therapy related (check all that apply)
181. Alkylating agent/radiation-related
182. Topoisomerase II inhibitor-related
183. Unknown
AML 184, ALL 191, acLK 199
Yes
No
Was imatinib mesylate given for pretransplant therapy anytime prior to start of prep regimen?
AML 185, ALL 192, acLK 200
Status at Transplantation:
Never treated
For hematologic CR
Primary Induction Failure (PIF)
AML 184, ALL 191, acLK 199
Y N Unk AML 186, ALL 193, acLK 201
Number AML 188, ALL 195, acLK 203
Complete Remission (CR)
L L Cytogenetic remission
1st
2nd
3rd or higher
Relapse
L L Molecular remission
AML 187, ALL 194, acLK 202
Number AML 189, ALL 196, acLK 204
1st
2nd
3rd or higher

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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Unknown

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:

177.
CHRONIC MYELOGENOUS LEUKEMIA (CML) (40)
Philadelphia chromosome+, Ph+, t(9;22)(q34;q11), or variant OR bcr/abl+

205.

Yes
No
206. Did recipient receive treatment prior to this HSCT?
(check all that apply) Mandatory for CIBMTR comprehensive Report Form Teams:
207. Combination chemotherapy
208. Dasatinib (Sprycel)
209. Hydroxyurea (HU)
210. Imatinib mesylate (Gleevec, Glivec)
211. Interferon
221. Nilotinib (Tasigna)
213. Other, specify:_________________________________________________
214.

Ph+/bcr+ (41)
Ph+/bcr- (42)
Ph+/bcr unknown (43)
Ph-/bcr+ (44)
Ph unknown/bcr+ (47)

Status at Transplantation:
221. Number
For Chronic Phase and CR Only:
215. Phase
1st
217/219. Cytogenetic remission:
Hematologic CR
2nd
Complete
(Q.216 is for
notnon-U.S.
required for
EBMT)
centers)
216. (Optional
3rd or higher
CML disease status before treatment that achieved this CR:
No
Chronic phase
Cytogenetics unknown
Accelerated phase
218./220. Molecular remission (bcr/abl):
Blast phase
Yes
Chronic phase
No
Accelerated phase
bcr/abl unknown
Blast crisis
CR=complete remission

177.

MYELODYSPLASTIC OR MYELOPROLIFERATIVE DISEASES (50)
Classification:
WHO: Chronic Myeloproliferative Diseases {MPS}
WHO: Myelodysplastic Syndromes (MDS)
At diagnosis

222.

At transplantation

223.
151
155
161
162
164
165
166
192
150

At diagnosis

If transformed
RA (51)
to AML, indicate
RARS (55)
AML as primary
RAEB-1 (61)
disease; also
RAEB-2 (62) complete Disease
RCMD (64)
Classification
RCMD/RS (65)
page 3
Isolated 5q-syndrome (66)
AML
MDS Unclassifiable/ {NOS} (50)

At transplantation

165
166
167

160
158
157

224. Date of MDS Dx::___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

Chronic Neutrophilic Leukemia (165)
Chronic Eosinophilic Leukemia (hypereosinophilic syndrome) (166)
Chronic Idiopathic myelofibrosis (with extra-medullary
hematopoiesis) {Myelofibrosis with myeloid metaplasia}
{Acute myelofibrosis or myelosclerosis} (167)
Chronic Myeloproliferative Disease, unclassifiable {MPS, NOS} (60)
Essential thrombocythemia (ET) (58)
Polycythemia vera (PCV) (57)
225.

DD

Was Janus kinase 2 (jak2) gene mutation positive?
Yes
No
Not Done

Other
At diagnosis
1
1

At transplantation

Chronic myelomonocytic leukemia (CMMol, CMML) (54)
MDS, therapy related (check all that apply)
Juvenile myelomonocytic leukemia (JMML, JCML, JCMML) (36)227. Alkylating agent/radiation-related

226. Was MDS/MPS therapy related?

Yes

No

MDS/MPS/CMML
231.
230. Status at Transplantation:
Supportive care or treatment without chemotherapy
Treated with chemotherapy
Relapse after CR
CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

Unknown

228.
229.

CR
Improvement, but no CR
NR – no response
Prog/worse

233. Number:

1st
2nd
3rd or higher

Topoisomerase II inhibitor-related
Unknown
JMML
Status at Transplantation: 234.
CCR – Continued Complete Response
CR – Complete Response
PR – Partial Response
MR – Minimal Response
SD – Stable Disease
232.
PD – Progressive Disease
Not assessed

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:

177.
Classification:
235. Atypical chronic myeloid leukemia {CML, NOS}
Ph-/bcr/abl- (45)
Ph-/bcr unknown (46)
Ph unknown/bcr- (48)
Ph unknown/bcr unknown (49)

OTHER LEUKEMIAS (30)
Chronic Lymphocytic Leukemia (CLL), NOS (34)
Chronic Lymphocytic Leukemia (CLL), B-cell/
Small Lymphocytic Lymphoma (SLL) (71)
Hairy Cell Leukemia (35)
Prolymphocytic Leukemia (PLL), NOS (37)
PLL, B-cell (73)
PLL, T-cell (74)
Other leukemia (39),
236. specify:____________________
Other leukemia, NOS (30)

237. Status at Transplantation:
Never treated
Complete Remission (CR)
nodular Partial Remission (nPR)
Partial Remission (PR)
No Response/Stable (NR/SD)
Progression
Relapse (untreated)

LYMPHOMAS
Classification:
177.
238.

Hodgkin Lymphoma (150)
244.B-cell Neoplasms

177.

Non-Hodgkin's Lymphoma
244. (continued)T-cell and NK-cell Neoplasms

Nodular lymphocyte
predominant Hodgkin
lymphoma (155)
Lymphocyte-rich (151)
Nodular sclerosis (152)
Mixed cellularity (153)
245.
Lymphoma depleted (154)
Hodgkin lymphoma,
NOS (150)

Grade I (102)
Grade II (103)
Grade III (104)
Unknown (164)

Burkitt’s lymphoma/Burkitt cell leukemia {ALL L3} (111)
High-grade B-cell lymphoma, Burkitt-like
(provisional entity) (135)
Diffuse large B-cell lymphoma (107)
If known, indicate subtype:
Intravascular large B-cell lymphoma (136)
Mediastinal large B cell lymphoma (125)
Primary effusion lymphoma (138)
Extranodal marginal zone B-cell lymphoma of MALT
type (122)
Follicular lymphoma (includes variants)
Lymphoplasmacytic lymphoma (121)
Mantle cell lymphoma (115)
Nodal marginal zone B-cell lymphoma
(+/– monocytoid B cells) (123)
Primary CNS lymphoma (118)
Splenic marginal zone B-cell lymphoma (124)
Waldenstrom macroglobulinemia (173)
Other B-cell lymphoma (129),
246. specify:_____________________

HL Status at Transplantation:
239.
Never treated
NHL
Primary refractory (less than PR to initial therapy)/PIF res
248.
Partial response (PR)
HL 240. Without prior CR Number
HL 241. NHL 250.
NHL 249. with prior CR
1st
{ CR confirmed
2nd
CR unconfirmed (CRU)*
3rd or higher
Rel

!

HL 242. NHL 251.

Adult T-cell lymphoma/leukemia (HTLV1+) (134)
Aggressive NK-cell leukemia (27)
Anaplastic large-cell lymphoma, T/null cell, primary
cutaneous type (147)
Anaplastic large-cell lymphoma, T/null cell, primary
systemic type (148)
Angioimmunoblastic T-cell lymphoma
(AILD) (131)
Enteropathy-type T-cell lymphoma (133)
Extranodal NK/T-cell lymphoma, nasal
type (137)
Hepatosplenic gamma-delta T-cell
lymphoma (145)
Mycosis fungoides (141)
Peripheral T-cell lymphoma {NOS} (130)
Subcutaneous panniculitis-like T-cell
lymphoma (146)
Sezary syndrome (142)
Large T-cell granular lymphocytic leukemia (126)
Other T/NK cell lymphoma (139),
247. specify:_____________________

Sensitivity to Chemotherapy:
Sensitive
Resistant
Untreated
Unknown

HL 243.
NHL 252.

* CRU – complete response with persistent scan abnormalities of unknown significance

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:
177.

PLASMA CELL DISORDERS (170)

253. Classification:
254.
Multiple myeloma-lgG (181)
Light Chain
STAGE AT DIAGNOSIS
Multiple myeloma-lgA (182)
Salmon & Durie:
Kappa
255.
256.
Multiple myeloma-lgD (183)
1 and
A
Lambda
Multiple myeloma-lgE (184)
2
B
Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185)
3
Multiple myeloma-light chain only (186)
OR
Multiple myeloma-non-secretory (187)
I.S.S.:
Plasma cell leukemia (172)
Serum β2-microglobulin:
Solitary plasmacytoma (no evidence of myeloma) (175)
1
μg/dL 2 mg/L 3 nmol/L
.
Primary Amyloidosis (174)
257.
Other Plasma Cell Disorder (179), specify:_____________________
260.
Serum albumin:
261. Status at Transplantation:
258.
1
g/dl 2 g/l
.
Never treated
Complete Remission (CR)
262.
Stage β2-mic S. albumin
Stringent Complete Remission (sCR)
259.
Number
1
<3.5
>3.5
Very Good Partial Response (VGPR)
1st
<3.5
<3.5
2
Partial Response (PR)
3.5-<5.5
—
2nd
Stable Disease (SD)
3
>5.5
—
3rd or higher
Progression
Relapse from CR (untreated)

177.
Classification:
263. Breast Cancer
Inflammatory (251)
Non-inflammatory (252)

266.

BREAST CANCER (250)

264. Stage at Diagnosis
0
I
II
III

265. Metastases
No distant metastases
Metastatic

Status at Transplantation:

267.

269.

Adjuvant (Stage II, III only)
Never treated
Primary refractory
Complete remission (CR)

Number

CR confirmed
CR unconfirmed (CRU)
1st partial response (PR1)
Relapse

268.

Local
Metastatic

Sensitivity to Chemotherapy

1st
2nd
3rd or higher

270.

Sensitive
Resistant
Untreated
Unknown
271.

* CRU – complete response with persistent scan abnormalities of unknown significance
177.

“OTHER” DISEASE (900)
274. Alternative HCT:
Specify (900):_______________________________________________
272.
Cardiac regeneration
Before using this category, check with transplant physician whether
Neurologic regeneration
diagnosis can be classified among options on
Tolerance Induction Pre-solid Organ Transplant
Disease Classification Pages 3-10.
275.
Other, specify:__________________________
273.For any "other" disease: Is a pathology report attached to this form?
Yes
No

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:

177. OTHER MALIGNANCIES (200)
Classifi
cation:
276.
Bone sarcoma (excluding Ewing family tumors) (273)
Ovary (214)
Central nervous system tumors (include CNS PNET) (220)
Pancreas (206)
Colorectal (228)
Prostate (209)
Ewing family tumors extra-osseous (includes PNET) (276)
Renal cell (208)
Ewing family tumors of bone (includes PNET) (275)
Retinoblastoma (223)
Germ cell tumor, extragonadal only (225)
Rhabdomyosarcoma (232)
Hepatobiliary (207)
Soft tissue sarcoma (274)
Lung cancer, non-small cell (203)
Testicular (210)
Lung cancer, small cell (202)
Thymoma (231)
Medulloblastoma (226)
Wilm tumor (221)
Melanoma (219)
277.
Other solid tumor (269), specify:____________________
Neuroblastoma (222)
Yes
280. Response Evaluation Criteria in Solid Tumors (RECIST) was used for this status evaluation:

278. Status at Transplantation:
Adjuvant
Never treated
CR
279.
CRU
Without prior CR
PR
with prior CR
NR/SD
PD
Relapse (untreated)

No
1 Complete response (CR) – Disappearance of all target lesions for a period of at least one month
2 Complete response with persistent imaging abnormalities of unknown signficance (CRU)
3 Partial response (PR) – At least 30% decrease in the sum of the longest diameter of measured lesions
(target lesions) taking as reference the baseline sum of longest diameters
4 Stable disease (NR/SD) – Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for
PD taking as reference the smallest sum of the longest diameters since the treatment started
5 Progressive disease (PD) – At least a 20% increase in the sum of the longest diameter of measured lesions
(target lesions), taking as reference the smallest sum of the longest diameters recorded since the treatment
started of the appearance of one or more new lesions

281. Number
(complete for CR, CRU or relapse)
1st
2nd
3rd or higher

282. Sensitivity to Chemotherapy
(complete only for relapse)
Sensitive (PR)
Resistant (SD, PD)
Untreated
Unknown

177. ANEMIA(300)/177. HEMOGLOBINOPATHY(310) Inherited abnormalities of erythrocyte
Severe aplastic anemia
differentiation or function
283. Classification:
285.
Fanconi anemia (311)
Diamond-Blackfan anemia (congenital PRCA) (312)
Acquired Severe Aplastic Anemia (SAA), NOS (301)
Shwachman-Diamond (305)
Acquired SAA, secondary to hepatitis (302)
Other constitutional anemia (319),
Acquired SAA, secondary to toxin/other drug (303)
Acquired Amegakaryocytosis (not congenital) (304)
286. specify: ________________________________________
Sickle cell disease (356)
Acquired Pure Red Cell Aplasia (PRCA) (not congenital) (306)
Sickle thalassemia (355)
Other acquired cytopenic syndrome (309),
284. specify: ________________________________________
Thalassemia NOS (350)
Other hemoglobinopathy (359),
Paroxysmal nocturnal hemoglobinuria (PNH) (56)
287. specify: ________________________________________
177. PLATELET DISORDERS (500)
288. Classification:
Congenital amegakaryocytosis/congenital thrombocytopenia (501)
Glanzmann thrombasthenia (502)
Other inherited platelet abnormalities (509), specify:289.
_________________________________
177. HISTIOCYTIC DISORDERS (570)
290. Classification:
Histiocytic disorders, NOS (570)
Familial erythro/hemophagocytic lymphohistiocytosis (FELH) (571)
Langerhans Cell Histiocytosis (Histiocytosis-X) (572)
Hemophagocytosis (reactive or viral associated) (573)
Malignant histiocytosis (574)
Other histiocytic disorder (579), specify: ___________________________________________
291.
CR=complete remission
CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:
177.

CIBMTR Recipient ID#:

INHERITED DISORDERS OF METABOLISM/OSTEOPETROSIS (520)

292. Classification:
Adrenoleukodystrophy (ALD) (543)
Aspartyl glucosaminuria (561)
B-glucuronidase deficiency (VII) (537)
Fucosidosis (562)
Gaucher disease (541)
Glucose storage disease (548)
Hunter syndrome (II) (533)
Hurler syndrome (IH) (531)
I-cell disease (546)
Krabbe disease (globoid leukodystrophy) (544)
Lesch-Nyhan (HGPRT deficiency) (522)
Mannosidosis (563)
Maroteaux-Lamy (VI) (536)
Metachromatic leukodystrophy (MLD) (542)

Morquio (IV) (535)
Mucolipidoses, NOS (540)
Mucopolysaccharidosis (V) (538)
Mucopolysaccharidosis, NOS (530)
Neimann-Pick disease (545)
Neuronal ceriod – lipofuscinosis (Batten disease) (523)
Osteopetrosis (malignant infantile osteopetrosis) (521)
Sanfilippo (III) (534)
Scheie syndrome (IS) (532)
Wolman disease (547)
Other inherited disorder of metabolism (529),
293.specify:____________________
Inherited Disorders of Metabolism, NOS (520)

177. IMMUNE DEFICIENCIES (400)
294. Classification:
Ataxia telangiectasia (451)
Bare lymphocyte syndrome (406)
DiGeorge anomaly (454)
CD 40 Ligand deficiency (464)
Cartilage hair hypoplasia (462)
Chediak-Higashi syndrome (456)
Chronic granulomatous disease (455)
Common variable immunodeficiency (457)
HIV infection (452)
Immune Deficiencies, NOS (400)
Leukocyte adhesion deficiencies (459)
Kostmann syndrome-congenital neutropenia (460)
Neutrophil actin deficiency (461)
Omenn syndrome (404)
Reticular dysgenesis (405)
SCID, ADA deficiency severe combined immune deficiency (401)
SCID, Absence of T and B cells (402)
SCID, Absence of T, normal B cell (403)
SCID, NOS (410)
SCID other (419), specify: 295.
__________________________________________________________________________________
Wiskott Aldrich syndrome (453)
X-linked lymphoproliferative syndrome (458)
Other immune deficiency (479), specify:296.
_______________________________________________________________________

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:

CIBMTR Recipient ID#:
177.

Classification

AUTOIMMUNE DISORDERS (600)

Involved Organs/Clinical Problem(s)

Primary Reason(s) for Transplant

(Check all that apply)

297.

297.

Connective Tissue Disease
Systemic sclerosis (607)

Yes No

normal elevated not done

diffuse cutaneous
limited cutaneous
lung parenchyma
pulmonary hypertension
systemic hypertension
310.
renal (biopsy type:___________)
esophagus
other GI Tract
Raynaud
CREST
321.
other, specify:________________

299.
301.
303.
305.
307.
309.
312.
314.
316.
318.
320.

Scl 70 positive
ACA positive
ANA

Systemic lupus erythematosus325.
328.
SLE (605)
331.
334.
336.
338.
340.
343.
346.
349.

327.
renal (biopsy type:___________)
330.
CNS (type:_________________)
333.
PNS (type:_________________)
lung
serositis
arthritis
342.
skin (type:_________________)
345.
hematological (type:_________)
348.
vasculitis (type:______________)
351.
other, specify:________________

326.
329.
332.
335.
337.
339.
341.
344.
347.
350.

352.
ANA
353
ds DNA
354.
C3
355.
C4
total complement356.
357.
other,
358.
specify:_________

359.
361.
363.
365.
367.
369.

SICCA
exocrine gland swelling
other organ lymphocytic infiltration
lymphoma, paraproteinemia
vasculitis
371.
other, specify:________________

360.
362.
364.
366.
368.
370.

Sjögren syndrome (608)

297.

Polymyositis-dermatomyositis372.
374.
(606)
376.
378.
381.
384.

373.
proximal weakness
generalized weakness (including bulbar)375.
377.
pulmonary fibrosis
379.
380
vasculitis (type:______________)
382.
383.
malignancy (type:____________)
385.
386.
other, specify:________________

297.

391.
Antiphospholipid syndrome (614)
394.
397.
399.
401.
404.

thrombosis (type:____________)
393.
396.
CNS (type:_________________)
abortion
skin (livedo, vasculitis)
hematological (type:_________)
403.
other, specify:________________
406.

297.

410.
Other connective tissue disease, specify (634):________________

297.

Antibodies:

298.
300.
302.
304.
306.
308.
311.
313.
315.
317.
319.

297.

297.

Miscellaneous Labs
@ Original Diagnosis

392.
395.
398.
400.
402.
405.

Vasculitis
Wegener granulomatosis (610) 411.
413.
415.
418.
420.

upper respiratory tract
pulmonary
417.
renal (biopsy type:____________)
skin
other, specify:________________
422.

412.
414.
416.
419.
421.

428.
431.
433.
435.
437.
439.

430.
renal (type:__________________)
mononeuritis multiplex
pulmonary hemorrhage
skin
GI Tract
441.
other, specify:________________

429.
432.
434.
436.
438.
440.

Polyarteritis nodosa
Classical (631)
Microscopic (632)

Yes No

322.
323.
324.

low
low
low

387.
CPK
typical biopsy 388.
389.
typical EMG
typical rash (DM)390.

anticardiolipin lgG
anticardiolipin lgM
lupus anticoagulant

Antibodies:

407.
408.
409.

normal elevated not done

c-ANCA positive 423.
424.
anti Pr3
425.
anti MPO
426.
c-ANCA IFA
427.
p-ANCA IFA
p-ANCA positive 442.
c-ANCA positive 443.
hepatitis serology444.

NOTE: Transplant Essential Data should be submitted at time of mobilization for all patients with autoimmune disease
CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:
continued
297. Classification

CIBMTR Recipient ID#:
177. AUTOIMMUNE DISORDERS

Involved Organs/Clinical Problem(s)

Primary Reason(s) for Transplant

(Check all that apply)

Miscellaneous Labs
(Check all that apply)

297. Other vasculitis
Churg-Strauss (635)
Giant cell arteritis (636)
Takayasu (637)
Behçet's Syndrome (638)
overlap necrotizing arteritis (639)
other vasculitis, specify (611):______________________
445.

297.

Arthritis
Rheumatoid arthritis (603)

Yes No

446.
448.
450.
453.
455.
458.

destructive arthritis
necrotizing vasculitis
eye (type:____________________)
452.
pulmonary
457.
extra-articular (specify:_____________)
other, specify:________________
460.

447.
449.
451.
454.
456.
459.

destructive arthritis
psoriasis
other, specify:________________
467.

462.
464.
466.

297.

Psoriatic arthritis/psoriasis (604)461.
463.
465.

297.

Juvenile idiopathic arthritis: systemic (Stills disease) (640)
Juvenile idiopathic arthritis: Oligoarticular (641)
Juvenile idiopathic arthritis: Polyarticular (642)
Juvenile idiopathic arthritis: Other, specify (643):______________________
468.
469.
Other, arthritis, specify (633):______________________

297.

Multiple sclerosis
Multiple sclerosis (MS) (602)

297.

Other Neurological Autoimmune Disease
Myasthenia gravis (601)
Other autoimmune neurological disorder, specify (644):______________________
479.

297.

297.

Yes No

470.
472.
474.
476.

primary progressive
secondary progressive
relapsing/remitting
478.
other specify:______________________

471.
473.
475.
477.

Hematological Autoimmune Disease
Idiopathic thrombocytopenic purpura (ITP) (645)
Hemolytic anemia (646)
Evan syndrome (647)
480.
other autoimmune cytopenia, specify (648):______________________
Bowel Disease
Crohn's disease (649)
Ulcerative colitis (650)
Other autoimmune bowel disorder, specify (651):______________________
481.

CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

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