Form 100 day 100 day post ted 100 day

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 when collected at 100 days post transplant, 1.0 hours per response when
collected at 6 and 12 months post transplant, and 1.5 hours per response annually
thereafter, 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.
CENTER IDENTIFICATION
CIBMTR Center # __________ EBMT Code (CIC) _______________
Hospital:_________________________________________________
Unit: ____________________________________________________
Contact person: ___________________________________________
Phone #: ________________________________________________
Fax #:___________________________________________________

DID A NEW MALIGNANCY, LYMPHOPROLIFERATIVE OR
MYELOPROLIFERATIVE DISORDER OCCUR?
Different from the disease for which HSCT performed
(not recurrence or transformation).
Yes
No
Unknown, If yes:
Date of diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Email:___________________________________________________
Date of this Report:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

Day 100

DD

6 months

Annual

REGISTRY USE ONLY
Date Received:____________________________ DE:____________

RECIPIENT IDENTIFICATION
CIBMTR recipient ID#:_______________________________________
Date of Birth:___ ___ ___ ___ - ___ ___ - ___ ___
MM

DD

Gender:
Male
Female
Disease:__________________________________________________

Donor Type:
Allogeneic
Autologous
Chronological # of this: HSCT#: ___ ___ DCI#: ___ ___
Date of HSCT for this follow-up:___ ___ ___ ___ - ___ ___ - ___ ___
MM

DD

100 Day Report Only
Is 'Date of HSCT' same as date given on Pre-TED?
Was HSCT Infusion given? If No,:
At least 1 dose of the prep regimen was given? If Yes,:
Patient died during prep regimen?
This HSCT is cancelled?
This HSCT is postponed?
New estimated date: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

YYYY

**

Never below

DD

MM

DD

Unknown

No

INITIAL PLATELET RECOVERY
(Optional for Non-U.S. Centers)

**

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

**

No, last assessment:

**

Never below

YYYY

MM

YYYY

Previously reported

MM

DD

Present, grade unknown

Maximum extent of Chronic GVHD during this period:
**
None
Limited
Extensive
Unknown
** Date of diagnosis of chronic GVHD:
** ___ ___ ___ ___ - ___ ___ - ___ ___
Continued from last report
MM

Lung cancer
Lymphoma or lymphoproliferative disease
Yes

DD

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

No

Unknown

Melanoma
Other skin malignancy (basal cell, squamous)
Myelodysplasia (MDS)/myeloproliferative (MPS) disorder

SURVIVAL
Survival status at latest follow-up:
Alive
Dead
Lost To Follow-Up (LTF)
Latest follow-up:
Last known date alive:
Day of the month
___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

is estimated
Main cause of death (check only one main cause):
Relapse/Progression/Persistent disease
HSCT related causes (check as many as appropriate):
GVHD
Pulmonary toxicity
Cardiac toxicity
Rejection/Poor graft function
Infection
VOD
Other:________________
New malignancy
Other:______________________________________________
Unknown

POST-HSCT THERAPY (Optional for Non-U.S. Centers)
Yes Masked Trial No Unk

Unknown

GRAFT VERSUS HOST DISEASE (Allo only)

YYYY

Hodgkin disease

DD

___ ___ ___ ___ - ___ ___ - ___ ___

Maximum Grade of Acute GVHD
**
0
I
II
III
IV

Genitourinary malignancy (kidney, bladder, ovary, testicle,
genitalia, uterus, cervix)

Other malignancy, specify:____________________________
Copy of pathology report/documentation attached?
Yes No

DD

MM

YYYY

Yes

Gastrointestinal malignancy (colon, rectum, stomach, pancreas,
intestine)

Thyroid cancer

___ ___ ___ ___ - ___ ___ - ___ ___

Previously reported

Did graft failure occur?

Clonal cytogenetic abnormality without leukemia or MDS

Sarcoma

INITIAL ANC RECOVERY
Was ≥0.5 x 109/L achieved for 3 consecutive labs?
** Yes, first date of 3 labs: ___ ___ ___ ___ - ___ ___ - ___ ___
No, last assessment:

Central nervous system (CNS) malignancy (glioblastoma,
astrocytoma)

Oropharyngeal cancer (tongue, buccal mucosa)

Yes No

**

Other leukemia (including ALL), specify:__________________

Is the tumor EBV positive?

HSCT

YYYY

DD

Breast cancer

Did the recipient receive a subsequent HSCT since the date of
contact from the last report?
Yes
No

YYYY

MM

Acute myeloid leukemia (AML/ANLL)

FGF (velafermin)?
Imatinib mesylate (Gleevec, Glivec)?**
KGF (palifermin, Kepivance)?**

HSCT FOR NON-MALIGNANT DISEASE ONLY
DCI given in this period?
Yes, also complete 'DCI' section on pg 2
No, send only pg 1
All Abbreviations on Pre-TED, pg 2
Post-TED (5/07) Page 1 of 2

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:

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

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:
___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

**
**
*

*

MM

DD

First CR date reported previously
No, never in CR from HSCT, date assessed:
___ ___ ___ ___ - ___ ___ - ___ ___
YYYY
MM
DD
Not evaluated
FIRST RELAPSE OR PROGRESSION AFTER HSCT
(in this period, any type, not persistent disease)
Yes, answer all 3 methods. If used, give the date used and the results.
No––(skip to ‘Additional Treatment’ below)

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

MM

DD

No, Date of Assessment:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Previously reported

MM

MM

DD

No, Date of Assessment:___ ___ ___ ___ - ___ ___ - ___ ___
Previously reported

MM

DD

Not evaluated

Relapse/progression detected by clinical/hematological method:
Yes,
Date first seen:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

No, Date of Assessment:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Previously reported

MM

DD

Not evaluated

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

Yes
Yes No *

Planned (given regardless of disease status/assessment
post-HSCT)
Not planned (given for relapse, progression, or persistent
disease)
METHOD OF LATEST DISEASE ASSESSMENT
(record most recent of each)
* In some circumstances, disease may be detected by molecular or cytogenetic testing, but may not be considered a relapse or progression. It should
still be reported. Disease detected?
No

Yes

Not evaluated

Molecular*
If yes, was the status considered a disease
Yes
No
relapse or progression?

Date latest assessed:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

Cytogenetic/FISH*

MM

DD

If yes, was the status considered a disease
Yes
No
relapse or progression?

Date latest assessed:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

Clinical/Hematologic
Date latest assessed:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

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

Not in CR

DONOR CELLULAR INFUSION (DCI)
Date of first DCI: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

Total # DCI in 10 weeks______
Type of cell(s) (check all that apply):
Lymphocytes
Fibroblasts
Dendritic cells
Mesenchymal
Other, specify:____________________
Indication:
Planned
Treat disease
Treat PTLD, EBV-Lym
Treat viral

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

Maximum Grade of Acute Graft Versus Host Disease
** (GVHD):
0
I
II
III
IV
Unknown
If another DCI was received in this reporting period, disease status
before next DCI:
CR
Not in CR
Not assessed

YYYY

MM

DD

Total # DCI in 10 weeks______
Type of cell(s) (check all that apply):
Lymphocytes
Fibroblasts
Dendritic cells
Mesenchymal
Other, specify:____________________
Indication:
Planned
Treat disease
Treat PTLD, EBV-Lym
Treat viral

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

Maximum Grade of Acute Graft Versus Host Disease
** (GVHD):
0
I
II
III
IV
Unknown

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

Method

Annual

Date of second DCI: ___ ___ ___ ___ - ___ ___ - ___ ___

Relapse/progression detected by cytogenetic/FISH method:
Yes,
Date first seen:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

6 months

DD

Not evaluated

YYYY

Day 100

Date:___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

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

If another DCI was received in this reporting period, disease status
before next DCI:
CR
Not in CR
Not assessed

Date of third DCI: ___ ___ ___ ___ - ___ ___ - ___ ___
YYYY

MM

DD

Total # DCI in 10 weeks______
Type of cell(s) (check all that apply):
Lymphocytes
Fibroblasts
Dendritic cells
Mesenchymal
Other, specify:____________________
Indication:
Planned
Treat disease
Treat PTLD, EBV-Lym
Treat viral

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

Maximum Grade of Acute Graft Versus Host Disease
** (GVHD):
0
I
II
III
IV
Unknown
If another DCI was received in this reporting period, disease status
before next DCI:
CR
Not in CR
Not assessed
Were there more than 3 instances of DCI infusions in this reporting
period?
Yes
No
If yes, copy this page and continue numbering fourth, fifth, etc.

DD

Post-TED (5/07) Page 2 of 2