Form PostTed

Stem Cell Therapeutic Outcomes Database

2450-Post-TED-081009-r2

Stem Cell Therapeutic Outcomes Database (Post-Trans)

OMB: 0915-0310

Document [pdf]
Download: pdf | pdf
[Q.] = extra question in FN2 application

Post-Transplant Essential Data
Note: “>100 Days Report” answer since last report
= symbol for answer that is only valid on >d100 evaluation.

19.

CENTER IDENTIFICATION
____________
930. CIBMTR Ctr #___ ___ ___ ___ ___ EBMT Code (CIC)931.
932. Hospital:_________________________________________________
933. Unit (circle one)*: A H O P Other, specify:933a.
__________________

Different from the disease for which HSCT performed
(not recurrence or transformation).

Yes

* Abbreviations, see Pre-TED pg 2

934. Contact person: (first name) _________________________________
935. (last name) _____________________________________________
938. Date of this Report:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

939.

Day 100

MM

No

Unknown

20. For all new malignancies except for "other skin malignancy (basal cell,

squamous)", was testing performed to determine the cell of origin?
Yes
No
the only new malignancy in this reporting period was
"other skin malignancy (basal cell, squamous)"
21. If yes, specify the cell origin of the new malignancy:

DD

Annual (Annual, specify year:921.___ ___ )

6 months

DID A NEW MALIGNANCY, LYMPHOPROLIFERATIVE OR
MYELOPROLIFERATIVE DISORDER OCCUR?

Recipient (host)
REGISTRY USE ONLY
901. Date Received:____________________________ DE:____________

cytogenetics, FISH) attached?

RECIPIENT IDENTIFICATION

MM

23.

DD

25.
942. Gender:
Male
Female
943. Disease:__________________________________________________ 28.
HSCT

30.

Donor Type:944. Allogeneic 945. Autologous
Chronological # of this:946.HSCT#: ___ ___947.DCI#: ___ ___
948. Date of HSCT for this follow-up:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

32.

DD

949. Did the recipient receive a subsequent HSCT since the date of contact from the last report?

Yes

No

34.
36.

950. Specify date:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

951. Was the subsequent HSCT indication autologous rescue?
Yes No

1.
2.
3.
4.
5.
6.

Yes

No 38.

100 Day Report Only
Is 'Date of HSCT' same as date given on Pre-TED?
Was HSCT Infusion given? If Yes—skip to Q.8, if No:
At least 1 dose of the prep regimen was given?
Patient died during prep regimen? If Yes—skip to Q.62
This HSCT is cancelled? If Yes—skip to Q.62
This HSCT is postponed? If Yes—complete Qs.62-74,
submit form

7. New estimated date: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

INITIAL ANC RECOVERY
8. Was ≥0.5 x 109/L achieved for 3 consecutive labs?
** Yes, first date of 3 labs: 9.___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

**

MM

DD

No, last assessment: 10.___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

**

MM

DD

Previously reported >d100
Unknown
Yes
No
INITIAL PLATELET RECOVERY

Yes, date Platelet >20 x 109/L:
13.___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

**

MM

DD

No, last assessment: 14.___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

**

Never below

No

Previously reported >d100

MM

DD

Unknown

Specify New Diseases Date of diagnosis: Y Y Y Y

MM

DD

Acute myeloid leukemia (AML/ANLL)

24.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Other leukemia (including ALL), specify: 27.
__________________

26.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Breast cancer

29.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Central nervous system (CNS) malignancy (glioblastoma, astrocytoma) 31.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
Clonal cytogenetic abnormality without leukemia or MDS

33.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Gastrointestinal malignancy (colon, rectum, stomach, pancreas,
intestine) 35.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
Genitourinary malignancy (kidney, bladder, ovary, testicle,
genitalia, uterus, cervix)

37.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Hodgkin disease

39.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

40.

Lung cancer

42.

Lymphoma or lymphoproliferative disease

41.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
43.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Yes
No
Unknown
44. Is the tumor EBV positive?
45.
Melanoma46.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
47.
Other skin malignancy (basal cell, squamous), specify:________________
49.
48.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

50.

Myelodysplasia (MDS)/myeloproliferative (MPS) disorder

52.

Oropharyngeal cancer (tongue, buccal mucosa)

54.
56.

Sarcoma 55.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
Thyroid cancer

58.

Other malignancy, specify:____________________________
60.

51.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
53.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
57.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___

Attach copy of report w/all identifiers removed, except birth date & ID numbers.
>1 new malignancy in this reporting period – copy page and repeat Qs.20-61

(Optional for Non-U.S. Centers)

**

Yes

59.Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
Yes No
61. Copy of pathology report/documentation attached?

Never below

11. Did graft failure occur?
12.

Origin unknown

If yes, attach a copy of the report with all identifiers removed,
except for birth date and ID numbers (reference Q22 on the report)

940. CIBMTR recipient ID#:___ ___ ___ ___ ___ ___ ___ ___ ___ ___
941. Date of Birth:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Donor

22. If yes, is a copy of the cell origin evaluation (VNTR,

SURVIVAL

62. Survival status at latest follow-up:

Alive
Dead
Lost To Follow-Up (LTF)
Latest follow-up:
Last known date alive:
Date of death
63.___
[64.]___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

GRAFT VERSUS HOST DISEASE (Allo only)
65. Main cause of death (check only one main cause):
Relapse/Progression/Persistent disease
15. Maximum Grade of Acute GVHD
HSCT related causes (check as many as appropriate):
**
0
I
II
III
IV
Present, grade unknown
66. GVHD
69. Pulmonary toxicity
Maximum extent of Chronic GVHD during this period:
67. Cardiac toxicity
70. Rejection/Poor graft function
16. ** None
Limited >d100
Extensive >d100
Unknown
68. Infection
71. VOD
** Date of diagnosis of chronic GVHD:
72. Other:________________
73.
New malignancy
**17.___ ___ ___ ___ - ___ ___ - ___ ___18. Continued from last report
YYYY

MM

DD

All Abbreviations on Pre-TED, pg 2
CIBMTR/EBMT/EUROCORD/FACT/NMDP Transplant Esential Data

Other:______________________________________________
74.
Unknown

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

Post-TED# (8/10/09) Page 1 of 2

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.

Post-Transplant Essential Data
Note: “>100 Days Report” answer since last report
= symbol for answer that is only valid on >d100 evaluation.

CIBMTR Center #:

CIBMTR Recipient ID#:

Report represents:

6 months

Annual

METHOD OF LATEST DISEASE ASSESSMENT/continued

POST-HSCT THERAPY (Optional for Non-U.S. Centers)

75. FGF (velafermin)?
76. Imatinib mesylate (Gleevec, Glivec)?**
77. KGF (palifermin, Kepivance)?**

Day 100

Yes Masked Trial No Unk

Method

Disease detected?
No

Yes

Not evaluated

99. ___ ___ ___ - ___ ___ - ___ ___
Date latest assessed:___
Cytogenetic/FISH*101.

[100.]

YYYY

relapse or progression?

HSCT FOR NON-MALIGNANT DISEASE ONLY

MM

DD

102.If yes, was the status considered a disease
Yes

No

Date latest assessed:___
103. ___ ___ ___ - ___ ___ - ___ ___

78. DCI given in this period?

105.

YYYY

MM

DD

Clinical/Hematologic
[104.]
Date latest assessed:___
106. ___ ___ ___ - ___ ___ - ___ ___

Yes, also complete 'DCI' section on pg 2 : starting at Q.110
No, send only pg 1

YYYY

MM

DD

MALIGNANT DISEASE EVALUATION FOR THIS HSCT
(non-malignant disease skip disease evaluation)

79.

WAS A CR EVER ACHIEVED IN REPONSE TO HSCT
(including any therapy planned as of Day 0, excluding any
change in therapy in response to disease assessment)?
**
Recipient already in CR at start of preparative regimen (N/Apl)
**
Yes, post-HSCT CR achieved, date:
80.___ ___ ___ ___ - ___ ___ - ___ ___

[107.] If a previous HSCT was performed for a different disease than this
HSCT, give status of original disease and date determined:

108.

CR

Not in CR

Date:___
109. ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

YYYY
MM
DD
DONOR CELLULAR INFUSION (DCI)
First CR date reported previously
No, never in CR >d100 from HSCT, date assessed:
110. Date of first DCI: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY
MM
DD
81.___ ___ ___ ___ - ___ ___ - ___ ___

**
**

YYYY

MM

DD

Date of best response was previously reported 111. Total # DCI in 10 weeks______
Type of cell(s) (check all that apply):
Not
evaluated
*
112.
Lymphocytes113. Fibroblasts114. Dendritic cells
82.
FIRST RELAPSE OR PROGRESSION AFTER HSCT
(in this period, any type, not persistent disease)
115. Mesenchymal116. Other, specify:____________________
117.
Yes, answer all 3 methods. If used, give the date used and the results.
No––(skip to ‘Additional Treatment’ below)
Treat GVHD
118. Indication:
*

83. Relapse/progression detected by molecular method:
Yes,
Date first seen:___
84. ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

YYYY

MM

DD

Planned
Treat disease
Treat PTLD, EBV-Lym
Treat viral

No, Date of Assessment:___
85. ___ ___ ___ - ___ ___ - ___ ___
Previously reported >d100

Not evaluated

Mixed Chimerism
Loss/Decreased Chimerism
Other, specify:
___________________________
119.

86. Relapse/progression detected by cytogenetic/FISH method:
120. Maximum Grade of Acute Graft Versus Host Disease
Yes,
Date first seen:___
87. ___ ___ ___ - ___ ___ - ___ ___
** (GVHD):
0
I
II
III
IV
Unknown
YYYY
MM
DD
No, Date of Assessment:___
88. ___ ___ ___ - ___ ___ - ___ ___
121. If another DCI was received in this reporting period, disease status
YYYY
MM
DD
Previously reported >d100

Not evaluated

before next DCI:

CR

Not in CR

Not assessed

89. Relapse/progression detected by clinical/hematological method:
Yes,
Date first seen:___
90. ___ ___ ___ - ___ ___ - ___ ___ 122. Date of second DCI: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY
MM
DD
YYYY
MM
DD
No, Date of Assessment:___
91. ___ ___ ___ - ___ ___ - ___ ___
123. Total # DCI in 10 weeks______
YYYY
MM
DD
Previously reported >d100

92.

Type of cell(s) (check all that apply):
Lymphocytes125. Fibroblasts126. Dendritic cells
Mesenchymal128. Other, specify:____________________
129.

Not evaluated

124.
127.

ADDITIONAL TREATMENT?
(skip to ‘Method’ Q.97
below)
No––(skip
below)

Yes
Yes No *

130.

93.

DCI (allo only)
(also complete ‘DCI’ section)

94.

Planned (given regardless of disease status/assessment
post-HSCT)

95.

Not planned (given for relapse, progression, or persistent
disease)

Indication:
Planned
Treat disease
Treat PTLD, EBV-Lym
Treat viral

Treat GVHD
Mixed Chimerism
Loss/Decreased Chimerism
Other, specify:
131. ___________________________

132. Maximum Grade of Acute Graft Versus Host Disease
** (GVHD):
0
I
II
III
IV
Unknown
METHOD OF LATEST DISEASE ASSESSMENT
(record most recent of each)
133. If another DCI was received in this reporting period, disease status
* In some circumstances, disease may be detected by molecular or cytogebefore next DCI:
CR
Not in CR
Not assessed
netic testing, but may not be considered a relapse or progression. It should
still be reported. Disease detected?
Method

Molecular*

[96.]

No

97.

Yes

146. Were there more than 2 instances of DCI infusions in this reporting

Not evaluated

98.If yes, was the status considered a disease
relapse or progression?

Yes

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

No

period?
Yes
No
If yes, copy this page and continue numbering third, fourth, etc.
US OMB Control No. 0915-0310, Expiration Date: 10/31/2010

Post-TED# (8/10/09) Page 2 of 2


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File TitlePost-TED_081009.indd
Authorlinda
File Modified2010-09-03
File Created2009-10-13

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