Form pre ted pre ted pre ted

Stem Cell Therapeutic Outcomes Database

Pre-TED form

Stem Cell Therapeutic Outcomes Database (Pre-TED)

OMB: 0915-0310

Document [pdf]
Download: pdf | pdf
OMB No: 0915Expiration Date:

Public Burden Statement

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
. 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
CENTER IDENTIFICATION
CIBMTR Center # ___________EBMT Code (CIC) _______________
Hospital:_________________________________________________
Other, specify: ____________________
Unit (circle)*: A H O P
* Abbreviations, see pg 2

Contact person: ___________________________________________
Phone #: ______________________ Fax #: ____________________
Email:___________________________________________________
Date of this Report:___ ___ ___ ___ - ___ ___ - ___ ___
changed
YYYY

MM

DD

CIBMTR USE ONLY
Report Form due?
Yes
No
Reg only
Date Received:____________________________ DE:_____________
RECIPIENT IDENTIFICATION
Universal recipient ID#: _____________________________________
CIBMTR
EBMT
Other _________________
ID assigned by:
BMT-CTN NMDP RCI-BMT SCTOD
Study ID #:___ ___ ___ ___
Consented for Research:
Yes
No
Male
Female
Gender:
Date of Birth:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

Optional for non-US centers:
Ethnicity:
Hispanic or Latino
Not Hispanic or Latino
Race (check all that apply):
White
Black/African American
American Indian/Alaska Native
Native Hawaiian/Other Pacific Islander

DD

Asian

DISEASE CLASSIFICATION
Complete and attach only the relevant Disease Classification Sheet
with date and status at transplantation:
Date of diagnosis of primary disease for HSCT:
Date of This Report___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Date of this HSCT: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

Chronological number of this HSCT: ________
If >1, most recent previous HSCT:
Date of This RDate::___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Date of This RType:

Auto

MM

DD

Allo

Institution where previous HSCT was performed if different from current:
Name: __________________________________________________
City: _________________________________ State: _____________
Country: _________________________________________________
Cell source for this HSCT (check all that apply):
BM
PBSC
UCB
Other: ____________________
Allo HSCT (for multiple donors check all that apply):
Male
Female
donor gender:
Donor Type:
NMDP
Autologous (self)
Multiple donors (skip HLA match only)
Allogeneic:
Syngeneic (monozygotic twin)
HLA-identical sibling (may include non-monozygotic twin)
HLA-matched other relative
HLA-mismatched relative
Degree of mismatch:

HSCT (continued)
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: ________________________
CD34 selection
ex vivo expansion
Other, specify: _______________________________________

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

Unrelated donor (complete # of mismatches on HLA lines)
Registry, specify:
Other, specify or UCB Bank:
__ __ __ __
_______________________________________
__ __ __ __
_______________________________________
A
B
C DRB1 DQB1 DPB1
__ __ __
__
__
__ Antigenic (2 digits)
__ __ __
__
__
__ Alletic (4 digits)
0=matched; 1=one mismatch; 2=2 mismatches; ND=not done

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

Performance Score pre-Preparative Regimen:
Karnofsky
Lansky
10
20
30
40
50
60
70
80
90
100
CMV-antibodies (IgG or Total) (Multiple donors: report any positive CMV test as reactive)
reactive non-reactive unknown not done
Recipient:
Donor (allo only):
PREPARATIVE REGIMEN
Was a preparative regimen given?
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 .............................. ___ ___ ___ ___
TLI, TNI, TAI ................ ___ ___ ___ ___
ALG, ALS, ATG, ATS (before d0)............ ___ ___ ___ ___
Horse
Rabbit
Other, specify:____________
anthracycline
daunorubicin ...................................... ___ ___ ___ ___
doxorubicin ........................................ ___ ___ ___ ___
idarubicin ........................................... ___ ___ ___ ___
bleomycin ............................................... ___ ___ ___ ___
busulfan .................................................. ___ ___ ___ ___
Oral
IV
Both
carboplatin .............................................. ___ ___ ___ ___
carmustine (BCNU) ................................ ___ ___ ___ ___
cisplatin .................................................. ___ ___ ___ ___
corticosteroids ........................................ ___ ___ ___ ___
cyclophosphamide .................................. ___ ___ ___ ___
cytarabine (Ara-C) .................................. ___ ___ ___ ___
etoposide (VP-16) .................................. ___ ___ ___ ___
fludarabine .............................................. ___ ___ ___ ___
ifosfamide ............................................... ___ ___ ___ ___
imatinib mesylate (Gleevec, Glivec) ............. ___ ___ ___ ___
lomustine (CCNU) .................................. ___ ___ ___ ___
melphalan (L-PAM) ................................. ___ ___ ___ ___
mitoxantrone ........................................... ___ ___ ___ ___
monoclonal antibody (MAb)g
Campath ............................................ ___ ___ ___ ___
Rituximab (Rituxan, anti-CD20)........... ___ ___ ___ ___
Gemtuzumab (Mylotarg, anti-CD33) .....___ ___ ___ ___
Other MAb ......................................... ___ ___ ___ ___
specify:_____________________
paclitaxel (Taxol, Xyotax) ........................ ___ ___ ___ ___
tenoposide (VM26) ................................. ___ ___ ___ ___
thiotepa ................................................... ___ ___ ___ ___
other, specify:______________ ............. ___ ___ ___ ___
radiolabeled MAb ................................................ units mCi mBq
Tositumomab (Bexxar) .................................___ ___ ___ . ___
Ibritumomab (Zevalin) ..................................___ ___ ___ . ___
Other rMab ...................................................___ ___ ___ . ___
specify:_____________________
Is the INTENT of the preparative regimen MYELOABLATIVE (allo
only)?
Yes
No, reason for NST/RIC (check all that apply):
Age of recipient
Comorbid conditions
Prior HSCT
Protocol-driven
Other, specify: _____________________________
Pre-TED (5/07) Page 1 of 10

Pre-Transplant Essential Data
CIBMTR Center #:

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

Is there a history of mechanical ventilation?
Yes
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?
Yes
No 'Allo' continue with Box A below, 'auto' continue with Box B below
Yes No NotDone Comorbidity

Definitions

Arrhythmia
Cardiac
Cerebrovascular disease
Diabetes
Heart valve disease
Hepatic, mild
Hepatic, moderate/severe
Infection
Inflammatory bowel disease
Obesity
Peptic ulcer
Psychiatric disturbance
Pulmonary, moderate
Pulmonary, severe
Renal, moderate/severe
Rheumatologic
Solid tumor, prior
Other

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

§ 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

Was GVHD prophylaxis planned/given?
(Check all that apply)

Yes

No

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

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

=
=
=
=
=
=
=
=
=

CIBMTR =
CIC =
CMV =
CR =

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

DCI
DLI
EBMT
EBV
FACT
FGF
FISH
GVHD
HSCT
KGF
NMDP
NOS
NST

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

Box B POST-HSCT DISEASE THERAPY PLANNED AS OF DAY 0
Is this HSCT part of a planned multiple (sequential) graft/HSCT
protocol?
Yes
No
Is additional post-HSCT therapy planned?
Yes
No
(Check all that apply) Optional for non-U.S. centers
bortezomib (Velcade)
Cellular therapy (e.g. DCI, DLI)
Intrathecal Chemotherapy
imatinib mesylate (Gleevec, Glivec)
lenalidomide (Revlimid)
Local radiotherapy
rituximab (Rituxan, Mabthera)
thalidomide (Thalomid)
Other, specify:________________________________________
OTHER TOXICITY MODIFYING REGIMEN
Optional for non-U.S. Centers
Was KGF (palifermin, Kepivance) started or is there a plan to use it?
Yes
No
Masked trial
Was FGF (velafermin) started or is there a plan to use it?
Yes
No
Masked trial

Donor Cellular Infusion
Donor Lymphocyte Infusion
European Group for Blood & Marrow Transplantation
Epstein Barr Virus
Foundation for the Accreditation of Cellular Therapy
Fibroblast Growth Factor
Fluorescent In-situ Hybridization
Graft versus Host Disease
Hematopoietic Stem Cell Transplant
Keratinocyte Growth Factor
National Marrow Donor Program
Not Otherwise Specified
Non-myeloablative Stem Cell Transplant

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

PBSC
PTLD
RBC
RCI-BMT

=
=
=
=

RIC
SCTOD
TBI, TLI, TNT
U
UCB
Unit
VOD

=
=
=
=
=
=
=

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

Pre-TED (5/07) Page 2 of 10

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

CIBMTR Recipient ID#:

ACUTE LEUKEMIAS
Select most specific W.H.O. classification:
Acute Lymphoblastic Leukemia (ALL)
Acute Leukemias of ambiguous lineage
Acute Myelogenous Leukemia (AML)
Precursor
B-cell
ALL
{L1/L2}
(191)
Acute undifferentiated leukemia (31)
AML with recurrent genetic abnormalities
Biphenotypic, bilineage or hybrid
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)
specify:___________________
APL with t(15;17)(q22;q12), (PML/RARα)
t(12;21)(p12;q22) ETV/CBF-α (195)
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)

Did AML transform from MDS or MPS?

Yes

No

Yes

No

Unknown

Yes

No

Unknown

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

Was AML therapy related?
AML, therapy related (check all that apply)
Alkylating agent/radiation-related
Topoisomerase II inhibitor-related
Unknown
Was imatinib mesylate given for pretransplant therapy anytime prior to start of prep regimen?
Status at Transplantation:
Never treated
Primary Induction Failure (PIF)
Complete Remission (CR)
Relapse

Number
1st

2nd

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

3rd or higher

For hematologic CR
Y N Unk
L L Cytogenetic remission
L L Molecular remission

Pre-TED (5/07) Page 3 of 10

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

CIBMTR Recipient ID#:

CHRONIC MYELOGENOUS LEUKEMIA (CML)
Philadelphia chromosome+, Ph+, t(9;22)(q34;q11), or variant OR bcr/abl+
Did recipient receive treatment prior to this HSCT?
Yes
No
(check all that apply) Mandatory for CIBMTR Research Teams:
Combination chemotherapy
Dasatinib (Sprycel)
Hydroxyurea (HU)
Imatinib mesylate (Gleevec, Glivec)
Interferon
Nilotinib (Tasigna)
Other, specify:_________________________________________________

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

Status at Transplantation:
For Chronic Phase and CR Only:
Phase
Number
Hematologic CR
1st
Cytogenetic remission:
Chronic phase
2nd
Molecular remission (bcr/abl):
Accelerated phase
3rd or higher
Blast crisis

Complete
Yes

No
No

Cytogenetics unknown
bcr/abl unknown

CR=complete remission

MYELODYSPLASTIC OR MYELOPROLIFERATIVE DISEASES
Classification:
WHO: Myelodysplastic Syndromes (MDS)

WHO: Chronic Myeloproliferative Diseases {MPS}

At diagnosis

At diagnosis

At transplantation

151
155
161
162
164
165
166
192
150

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

At transplantation

165
166
167

160
158
157

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

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

MM

DD

Other
At diagnosis
1
1

At transplantation

Chronic myelomonocytic leukemia (CMMol, CMML) (54)
Juvenile myelomonocytic leukemia (JMML, JCML, JCMML) (36)

Was MDS/MPS therapy related?

Yes

MDS/MPS/CMML
Status at Transplantation:
Supportive care or treatment without chemotherapy
Treated with chemotherapy
Relapse after CR

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

No

Unknown

MDS, therapy related (check all that apply)
Alkylating agent/radiation-related
Topoisomerase II inhibitor-related
Unknown

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

1st
2nd
3rd or higher

JMML
Status at Transplantation:
CCR – Continued Complete Response
CR – Complete Response
PR – Partial Response
MR – Minimal Response
SD – Stable Disease
PD – Progressive Disease
Not assessed

Pre-TED (5/07) Page 4 of 10

Pre-Transplant Essential Data
Disease Classification Sheet
CIBMTR Center #:
Classification:
Atypical chronic myeloid leukemia {CML, NOS}
Ph-/bcr/abl- (45)
Ph-/bcr unknown (46)
Ph unknown/bcr- (48)
Ph unknown/bcr unknown (49)

CIBMTR Recipient ID#:
OTHER LEUKEMIAS
Chronic Lymphocytic Leukemia (CLL), NOS (34)
Chronic Lymphocytic Leukemia (CLL), B-cell/
Small Lymphocytic Lymphoma (SLL) (71)
CLL, T-cell (72)
Hairy Cell Leukemia (35)
Prolymphocytic Leukemia (PLL), NOS (37)
PLL, B-cell (73)
PLL, T-cell (74)
Other leukemia (39),
specify:____________________
Other leukemia, NOS (30)

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:
Non-Hodgkin's Lymphoma

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

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

B-cell Neoplasms
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),
specify:_____________________

Status at Transplantation:
Never treated
Primary refractory (less than PR to initial therapy)/PIF res
Partial response (PR)
Without prior CR Number
with prior CR
CR confirmed
CR unconfirmed (CRU)*
Rel

1st
2nd
3rd or higher

T-cell and NK-cell Neoplasms
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),
specify:_____________________

Sensitivity to Chemotherapy:
Sensitive
Resistant
Untreated
Unknown

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

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

Pre-TED (5/07) Page 5 of 10

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

CIBMTR Recipient ID#:
PLASMA CELL DISORDERS

Classification:
Multiple myeloma-lgG (181)
Multiple myeloma-lgA (182)
Multiple myeloma-lgD (183)
Multiple myeloma-lgE (184)
Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185)
Multiple myeloma-light chain only (186)
Multiple myeloma-non-secretory (187)
Plasma cell leukemia (172)
Solitary plasmacytoma (no evidence of myeloma) (175)
Primary Amyloidosis (174)
Other Plasma Cell Disorder (179), specify:_____________________
Status at Transplantation:
Never treated
Complete Remission (CR)
Stringent Complete Remission (sCR)
Very Good Partial Response (VGPR)
Partial Response (PR)
Stable Disease (SD)
Progression
Relapse from CR (untreated)

STAGE AT DIAGNOSIS
Salmon & Durie:
1 and
A
2
B
3

Light Chain
Kappa
Lambda

OR

I.S.S.:
Serum β2-microglobulin:
.

1

μg/dL

1

g/dl

2

mg/L

3

nmol/L

Serum albumin:
.
Number
1st
2nd
3rd or higher

2

g/l

Stage β2-mic S. albumin
1
<3.5
>3.5
<3.5
<3.5
2
3.5-<5.5
—
3
>5.5
—

BREAST CANCER
Classification:
Breast Cancer
Inflammatory (251)
Non-inflammatory (252)

Stage at Diagnosis
0
I
II
III

Metastases
No distant metastases
Metastatic

Status at Transplantation:
Adjuvant (Stage II, III only)
Never treated
Primary refractory
Complete remission (CR)

Number

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

1st
2nd
3rd or higher

Sensitivity to Chemotherapy
Sensitive
Resistant
Untreated
Unknown

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

“OTHER” DISEASE
Alternative HCT:
Specify (900):_______________________________________________
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.
Other, specify:__________________________
For any "other" disease: Is a pathology report attached to this form?
Yes
No

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

Pre-TED (5/07) Page 6 of 10

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

CIBMTR Recipient ID#:

OTHER MALIGNANCIES
Classification:
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)
Other solid tumor (269), specify:____________________
Neuroblastoma (222)
Response Evaluation Criteria in Solid Tumors (RECIST) was used for this status evaluation:
Yes

Status at Transplantation:
Adjuvant
Never treated
CR
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

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

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

ANEMIA/HEMOGLOBINOPATHY
Classification:
Diamond-Blackfan anemia (congenital PRCA) (312)
Acquired Severe Aplastic Anemia (SAA), NOS (301)
Schwachmann-Diamond (305)
Acquired SAA, secondary to hepatitis (302)
Other constitutional anemia (319),
Acquired SAA, secondary to toxin/other drug (303)
specify: ________________________________________
Acquired Amegakaryocytosis (not congenital) (304)
Sickle cell disease (356)
Acquired Pure Red Cell Aplasia (PRCA) (not congenital) (306)
Sickle thalassemia (355)
Other acquired cytopenic syndrome (309),
Thalassemia NOS (350)
specify: ________________________________________
Other hemoglobinopathy (359),
Paroxysmal nocturnal hemoglobinuria (PNH) (56)
specify: ________________________________________
Fanconi anemia (311)
PLATELET DISORDERS
Classification:
Congenital amegakaryocytosis/congenital thrombocytopenia (501)
Glanzmann thrombasthenia (502)
Other inherited platelet abnormalities (509), specify: _________________________________
HISTIOCYTIC DISORDERS
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: ___________________________________________
CR=complete remission
CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

Pre-TED (5/07) Page 7 of 10

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

CIBMTR Recipient ID#:

INHERITED DISORDERS OF METABOLISM/OSTEOPETROSIS
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)
Polysaccharide hydrolase abnormalities, NOS (560)
Sanfilippo (III) (534)
Scheie syndrome (IS) (532)
Wolman disease (547)
Other inherited disorder of metabolism (529),
specify:____________________
Inherited Disorders of Metabolism, NOS (520)

IMMUNE DEFICIENCIES
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: __________________________________________________________________________________
Wiskott Aldrich syndrome (453)
X-linked lymphoproliferative syndrome (458)
Other immune deficiency (479), specify: _______________________________________________________________________

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

Pre-TED (5/07) Page 8 of 10

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

CIBMTR Recipient ID#:
AUTOIMMUNE DISORDERS

Classification

Involved Organs/Clinical Problem(s)

Primary Reason(s) for Transplant

(Check all that apply)

Connective Tissue Disease
Systemic sclerosis (607)

Systemic lupus erythematosus
SLE (605)

Yes No

Miscellaneous Labs
@ Original Diagnosis

Antibodies:

normal elevated not done

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

Scl 70 positive
ACA positive
ANA

renal (biopsy type:___________)
CNS (type:_________________)
PNS (type:_________________)
lung
serositis
arthritis
skin (type:_________________)
hematological (type:_________)
vasculitis (type:______________)
other, specify:________________

ANA
ds DNA
C3
C4
total complement
other,
specify:_________

Sjögren syndrome (608)

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

Polymyositis-dermatomyositis

proximal weakness
generalized weakness (including bulbar)
pulmonary fibrosis
vasculitis (type:______________)
malignancy (type:____________)
other, specify:________________

CPK
typical biopsy
typical EMG
typical rash (DM)

thrombosis (type:____________)
CNS (type:_________________)
abortion
skin (livedo, vasculitis)
hematological (type:_________)
other, specify:________________

anticardiolipin lgG
anticardiolipin lgM
lab lupus inhibitor
lupus anticoagulant

(606)

Antiphospholipid syndrome (614)

low
low
low

Other connective tissue disease, specify (634):________________
Vasculitis
Wegener granulomatosis (610)

Polyarteritis nodosa
Classical (631)
Microscopic (632)

Yes No

upper respiratory tract
pulmonary
renal (biopsy type:____________)
skin
other, specify:________________
renal (type:__________________)
mononeuritis multiplex
pulmonary hemorrhage
skin
GI Tract
other, specify:________________

Antibodies:

normal elevated not done

c-ANCA positive
anti Pr3
anti MPO
c-ANCA IFA
p-ANCA IFA
p-ANCA positive
c-ANCA positive
hepatitis serology

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

Pre-TED (5/07) Page 9 of 10

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

CIBMTR Recipient ID#:
AUTOIMMUNE DISORDERS

Classification

Involved Organs/Clinical Problem(s)

Primary Reason(s) for Transplant

(Check all that apply)

(Check all that apply)

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

Yes No

Arthritis
Rheumatoid arthritis (603)

Yes No

Psoriatic arthritis/psoriasis (604)

Miscellaneous Labs

destructive arthritis
necrotizing vasculitis
eye (type:____________________)
pulmonary
extra-articular (specify:_____________)
other, specify:________________
destructive arthritis
psoriasis
other, specify:________________

Juvenile idiopathic arthritis: systemic (Stills disease) (640)
Juvenile idiopathic arthritis: Oligoarticular (641)
Juvenile idiopathic arthritis: Polyarticular (642)
Juvenile idiopathic arthritis: Other, specify (643):______________________
Other, arthritis, specify (633):______________________
Multiple sclerosis
Multiple sclerosis (MS) (602)

Yes No

primary progressive
secondary progressive
relapsing/remitting
other specify:______________________

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

Yes No

Hematological Autoimmune Disease
Idiopathic thrombocytopenic purpura (ITP) (645)
Hemolytic anemia (646)
Evan syndrome (647)
other autoimmune cytopenia, specify (648):______________________

Yes No

Bowel Disease
Crohn's disease (649)
Ulcerative colitis (650)
Other autoimmune bowel disorder, specify (651):______________________

Yes No

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

Pre-TED (5/07) Page 10 of 10


File Typeapplication/pdf
AuthorHRSA
File Modified2007-05-22
File Created2007-05-16

© 2024 OMB.report | Privacy Policy