Form 1 Post-TED

Stem Cell Therapeutic Outcomes Database

3-Form 2450 PostTED r3

Stem Cell Therapeutic Outcomes Database (Post-Trans)

OMB: 0915-0310

Document [pdf]
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2450: Post-Transplant Essential Data

Registry Use Only
Sequence Number:

Date Received:

Key Fields
Abbreviations used throughout this form and their definitions can be found here: Appendix A

OMB No: 0915-0310
Expiration Date: 12/31/2013
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 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.Expiration date: 12/31/2013
___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Sequence
Number
ELSE GOTO Date Received
Date Received:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO CIBMTR Center #
Center Identification
CIBMTR Center Number: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
ELSE GOTO EBMT Code (CIC)
EBMT Code (CIC) ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
ELSE GOTO Hospital
Hospital: ________________________
ELSE GOTO Unit
Unit:
(check only one)
O adult
O hematology
O oncology
O pediatric
O other
IF Unit:= other
THEN GOTO Specify
ELSE GOTO First Name
Specify: ________________________
ELSE GOTO First Name
CIBMTR Form 2450 revision 3 (page 1 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___
Contact person: First Name:
ELSE GOTO Last Name

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

________________________

Last Name: ________________________
ELSE GOTO Date of This Report
Date of This Report:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO Follow-Up
Follow-Up:
O day 100
O 6 months
O annual
IF Follow-Up:= annual
THEN GOTO specify year
ELSE GOTO CIBMTR Recipient ID #
specify year ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
ELSE GOTO CIBMTR Recipient ID #
Recipient Identification
CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
ELSE GOTO Date of Birth:
Date of Birth:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO Gender
Gender:
O male
O female
ELSE GOTO Disease
Disease: ________________________
ELSE GOTO Allogeneic
(Check all that apply)
Donor Type
Allogeneic
ELSE GOTO Autologous
Autologous
ELSE GOTO Chronological # of this HSCT #
Chronological number of this: HSCT #:
ELSE GOTO DCI #

___ ___ ___ ___ ___

DCI: ___ ___ ___ ___ ___
ELSE GOTO Date of HSCT for this follow-up:

Date of HSCT for this follow-up:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO Did the recipient receive a subsequent HSCT since the date of contact from the last report?
Did the recipient receive a subsequent HSCT since the date of contact from the last report?
O yes
O no
IF Did the recipient receive a subsequent HSCT since the date of contact from the last report?:= no
THEN GOTO (1) Is 'Date of HSCT' same as date given on Pre-TED?
ELSE GOTO Date of subsequent HSCT
Date of subsequent HSCT:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO Was the subsequent HSCT indication autologous rescue?
CIBMTR Form 2450 revision 3 (page 2 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Was the subsequent HSCT indication autologous rescue?
O yes
O no
ELSE GOTO (1) Is 'Date of HSCT' same as date given on Pre-TED?

100 Day Report Only
1 Is 'Date of HSCT' same as date given on Pre-TED?
O yes
O no
ELSE GOTO (2) Was HSCT Infusion given?
2 Was HSCT Infusion given?
O yes
O no
IF (2) Was HSCT Infusion given?:= no
THEN GOTO (3) At least 1 dose of the prep regimen was given?
9
ELSE GOTO (8) Was ≥0.5 x 10 /L achieved for 3 consecutive labs?
3 At least 1 dose of the prep regimen was given?
O yes
O no
ELSE GOTO (4) Patient died during prep regimen?
4 Patient died during prep regimen?
O yes
O no
IF (4) Patient died during prep regimen?:= yes
THEN GOTO (62) Survival status at latest follow-up:
ELSE GOTO (5) This HSCT is cancelled?
5 This HSCT is cancelled?
O yes
O no
IF (5) This HSCT is cancelled?:= yes
THEN GOTO (62) Survival status at latest follow-up:
ELSE GOTO (6) This HSCT is postponed?
6 This HSCT is postponed?
O yes
O no
IF (6) This HSCT is postponed?:= yes
THEN GOTO (7) New estimated date:
9
ELSE GOTO (8) Was ≥0.5 x 10 /L achieved for 3 consecutive labs?
7 New estimated date:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
9
ELSE GOTO (8) Was ≥0.5 x 10 /L achieved for 3 consecutive labs?

CIBMTR Form 2450 revision 3 (page 3 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 1-7

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Initial ANC Recovery

Questions: 8-11

Note: ">100 Days Report" answer since last report
9

8 Was ≥0.5 x 10 /L achieved for 3 consecutive labs?
O yes
O no
O never below
O previously reported (answer is only valid on > d100 evaluation)
O unknown
9
IF (8) Was ≥0.5 x 10 /L achieved for 3 consecutive labs?:= yes
THEN GOTO (9) First date of 3 consecutive labs:
ELSE GOTO (11) Did graft failure occur?
9
IF (8) Was ≥0.5 x 10 /L achieved for 3 consecutive labs?:= no
THEN GOTO (10) Date of last assessment:
ELSE GOTO (11) Did graft failure occur?
9 First date of 3 consecutive labs:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (11) Did graft failure occur?

10 Date of last assessment:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (11) Did graft failure occur?

11 Did graft failure occur?
O yes
O no
ELSE GOTO (12) Initial platelet recovery

Initial Platelet Recovery
(Optional for Non-U.S. Centers)
12 Initial platelet recovery
O yes
O no
O never below
O previously reported (answer is only valid on > d100 evaluation)
O unknown
IF (12) Initial platelet recovery:= yes
9
THEN GOTO (13) Date Platelet > 20 x 10 /L:
ELSE GOTO (15) Maximum Grade of Acute GVHD
IF (12) Initial platelet recovery:= no
THEN GOTO (14) Date of last assessment:
ELSE GOTO (15) Maximum Grade of Acute GVHD
9

13 Date Platelet > 20 x 10 /L:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
9
IF (13) Date Platelet > 20 x 10 /L::= EXISTS AND Autologous:= 1
THEN GOTO (19) New malignancy or disorder?
ELSE GOTO (15) Maximum Grade of Acute GVHD

14 Date of last assessment:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
IF (14) Date of last assessment::= EXISTS AND Autologous:= 1
THEN GOTO (19) New malignancy or disorder?
ELSE GOTO (15) Maximum Grade of Acute GVHD

CIBMTR Form 2450 revision 3 (page 4 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 12-14

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Graft versus Host Disease (Allo only)

Questions: 15-18

15 Maximum Grade of Acute GVHD
O 0
O I
O II
O III
O IV
O Present, grade unknown
ELSE GOTO (16) Maximum extent of Chronic GVHD during this period:
16 Maximum extent of Chronic GVHD during this period:
O none
O limited
O extensive
O unknown
IF (16) Maximum extent of Chronic GVHD during this period::= limited
THEN GOTO (17) Date of diagnosis of chronic GVHD:
ELSE GOTO (19) New malignancy or disorder?
IF (16) Maximum extent of Chronic GVHD during this period::= extensive
THEN GOTO (17) Date of diagnosis of chronic GVHD:
ELSE GOTO (19) New malignancy or disorder?
17 Date of diagnosis of chronic GVHD:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (18) Continued from last report (answer is only valid on > d100 evaluation)

18 Continued from last report (answer is only valid on > d100 evaluation)
O yes
O no
ELSE GOTO (19) New malignancy or disorder?

New Malignancy, Lymphoproliferative or Myeloproliferative Disorder

Questions: 19-61

19 Did a new malignancy, lymphoproliferative or myeloproliferative disorder appear that is different from the disease for which
the HSCT was performed?
O yes
O no
IF (19) New malignancy or disorder?:= no
THEN GOTO (62) Survival status at latest follow-up:
ELSE GOTO (20) For all new malignancies except for "other skin malignancy (basal cell, squamous)," was testing
performed to determine the cell of origin?
20 For all new malignancies except for "other skin malignancy (basal cell, squamous)," was testing performed to
determine the cell of origin?
O yes
O no
O the only new malignancy in this reporting period was "other skin malignancy (basal cell, squamous)"
IF (20) For all new malignancies except for "other skin malignancy (basal cell, squamous)," was testing
performed to determine the cell of origin?:= yes
THEN GOTO (21) Specify the cell origin of the new malignancy:
ELSE GOTO (23) Acute myeloid leukemia (AML / ANLL)
21 Specify the cell origin of the new malignancy:
O recipient (host)
O donor
O origin unknown
ELSE GOTO (22) Is a copy of the cell origin evaluation (VNTR, cytogenetics, FISH) attached?

CIBMTR Form 2450 revision 3 (page 5 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

22 Is a copy of the cell origin evaluation (VNTR, cytogenetics, FISH) attached?
O yes
O no
ELSE GOTO (23) Acute myeloid leukemia (AML / ANLL)
Specify which new disease(s) occurred:
23 Acute myeloid leukemia (AML / ANLL)
O yes
O no
IF (23) Acute myeloid leukemia (AML / ANLL):= yes
THEN GOTO (24) Date of diagnosis
ELSE GOTO (25) Other leukemia, including ALL
24 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (25) Other leukemia, including ALL

25 Other leukemia, including ALL
O yes
O no
IF (25) Other leukemia, including ALL:= yes
THEN GOTO (26) Date of diagnosis
ELSE GOTO (28) Breast cancer
26 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (27) Specify other leukemia

27 Specify other leukemia: ________________________
ELSE GOTO (28) Breast cancer
28 Breast cancer
O yes
O no
IF (28) Breast cancer:= yes
THEN GOTO (29) Date of diagnosis
ELSE GOTO (30) CNS malignancy
29 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (30) CNS malignancy

30 Central nervous system (CNS) malignancy (glioblastoma, astrocytoma)
O yes
O no
IF (30) CNS malignancy:= yes
THEN GOTO (31) Date of diagnosis
ELSE GOTO (32) Clonal cytogenetic abnormality
31 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (32) Clonal cytogenetic abnormality

32 Clonal cytogenetic abnormality without leukemia or MDS
O yes
O no
IF (32) Clonal cytogenetic abnormality:= yes
THEN GOTO (33) Date of diagnosis
ELSE GOTO (34) Gastrointestinal malignancy
33 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (34) Gastrointestinal malignancy

CIBMTR Form 2450 revision 3 (page 6 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

34 Gastrointestinal malignancy (colon, rectum, stomach, pancreas, intestine)
O yes
O no
IF (34) Gastrointestinal malignancy:= yes
THEN GOTO (35) Date of diagnosis
ELSE GOTO (36) Genitourinary malignancy
35 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (36) Genitourinary malignancy

36 Genitourinary malignancy (kidney, bladder, ovary, testicle, genitalia, uterus, cervix)
O yes
O no
IF (36) Genitourinary malignancy:= yes
THEN GOTO (37) Date of diagnosis
ELSE GOTO (38) Hodgkin disease
37 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (38) Hodgkin disease

38 Hodgkin disease
O yes
O no
IF (38) Hodgkin disease:= yes
THEN GOTO (39) Date of diagnosis
ELSE GOTO (40) Lung cancer
39 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (40) Lung cancer

40 Lung cancer
O yes
O no
IF (40) Lung cancer:= yes
THEN GOTO (41) Date of diagnosis
ELSE GOTO (42) Lymphoma or Lymphoproliferative disease
41 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (42) Lymphoma or Lymphoproliferative disease

42 Lymphoma or lymphoproliferative disease
O yes
O no
IF (42) Lymphoma or Lymphoproliferative disease:= yes
THEN GOTO (43) Date of diagnosis
ELSE GOTO (45) Melanoma
43 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (44) Is the tumor EBV positive?

44 Is the tumor EBV positive?
O yes
O no
O unknown
ELSE GOTO (45) Melanoma

CIBMTR Form 2450 revision 3 (page 7 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

45 Melanoma
O yes
O no
IF (45) Melanoma:= yes
THEN GOTO (46) Date of diagnosis
ELSE GOTO (47) Other skin malignancy
46 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (47) Other skin malignancy

47 Other skin malignancy (basal cell, squamous)
O yes
O no
IF (47) Other skin malignancy:= yes
THEN GOTO (48) Date of diagnosis
ELSE GOTO (50) MDS/MPS
48 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (49) Specify other skin malignancy

49 Specify other skin malignancy:
ELSE GOTO (50) MDS/MPS

________________________

50 Myelodysplasia (MDS) / myeloproliferative (MPS) disorder
O yes
O no
IF (50) MDS/MPS:= yes
THEN GOTO (51) Date of diagnosis
ELSE GOTO (52) Oropharyngeal cancer
51 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (52) Oropharyngeal cancer

52 Oropharyngeal cancer (tongue, buccal mucosa)
O yes
O no
IF (52) Oropharyngeal cancer:= yes
THEN GOTO (53) Date of diagnosis
ELSE GOTO (54) Sarcoma
53 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (54) Sarcoma

54 Sarcoma
O yes
O no
IF (54) Sarcoma:= yes
THEN GOTO (55) Date of diagnosis
ELSE GOTO (56) Thyroid cancer
55 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (56) Thyroid cancer

56 Thyroid cancer
O yes
O no
IF (56) Thyroid cancer:= yes
THEN GOTO (57) Date of diagnosis
ELSE GOTO (58) Other new malignancy
CIBMTR Form 2450 revision 3 (page 8 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

57 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (58) Other new malignancy

58 Other new malignancy
O yes
O no
IF (58) Other new malignancy:= yes
THEN GOTO (59) Date of diagnosis
ELSE GOTO (61) Is a report attached?
59 Date of diagnosis

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (60) Specify other new malignancy

60 Specify other new malignancy: ________________________
ELSE GOTO (61) Is a report attached?
61 Is a pathology / autopsy report or other documentation attached?
O yes
O no
ELSE GOTO (62) Survival status at latest follow-up:

Survival
62 Survival status at latest follow-up:
O alive
O dead
IF (62) Survival status at latest follow-up::= dead
THEN GOTO (64) Date of death:
ELSE GOTO (65) Main cause of death (check only one main cause):
IF (62) Survival status at latest follow-up::= alive
THEN GOTO (63) Latest follow-up:
ELSE GOTO (65) Main cause of death (check only one main cause):
63 Latest follow-up:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (75) FGF (velafermin)?

64 Date of death:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (65) Main cause of death (check only one main cause):

65 Main cause of death (check only one main cause):
O Relapse/Progression/Persistent disease
O HSCT related causes
O new malignancy
O Other
O unknown
IF (65) Main cause of death (check only one main cause)::= HSCT related causes
THEN GOTO (66) GVHD
ELSE GOTO (75) FGF (velafermin)?
IF (65) Main cause of death (check only one main cause)::= Other
THEN GOTO (74) Other, specify
ELSE GOTO (75) FGF (velafermin)?
(Check as many as appropriate):
66 GVHD
O yes
O no
ELSE GOTO (67) Cardiac toxicity
CIBMTR Form 2450 revision 3 (page 9 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 62-74

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

67 Cardiac toxicity
O yes
O no
ELSE GOTO (68) Infection
68 Infection
O yes
O no
ELSE GOTO (69) Pulmonary toxicity
69 Pulmonary toxicity
O yes
O no
ELSE GOTO (70) Rejection/Poor graft function
70 Rejection/Poor graft function
O yes
O no
ELSE GOTO (71) VOD
71 VOD
O yes
O no
ELSE GOTO (72) Other
72 Other
O yes
O no
IF (72) Other:= yes
THEN GOTO (73) Specify:
ELSE GOTO (75) FGF (velafermin)?
73 Specify: ________________________
ELSE GOTO (75) FGF (velafermin)?
74 Specify: ________________________
ELSE GOTO (75) FGF (velafermin)?

Post-HSCT Therapy
(Optional for Non-U.S. Centers)
75 FGF (velafermin)?
O yes
O masked trial
O no
O unknown
ELSE GOTO (76) Imatinib mesylate (Gleevec, Glivec)?
76 Imatinib mesylate (Gleevec, Glivec)?
O yes
O masked trial
O no
O unknown
ELSE GOTO (77) KGF (palifermin, Kepivance)?
77 KGF (palifermin, Kepivance)?
O yes
O masked trial
O no
O unknown
ELSE GOTO (78) DCI given in this period?
CIBMTR Form 2450 revision 3 (page 10 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 75-77

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

HSCT for Non-Malignancy Disease Only

Questions: 78-78

78 DCI given in this period?
O yes
O no
IF (78) DCI given in this period?:= yes
THEN GOTO (110) Date of DCI:
ELSE GOTO End of Form

Malignant Disease Evaluation for this HSCT

Questions: 79-81

79 Was a CR ever achieved in response to HSCT (including any therapy as of Day 0, excluding any change in therapy in
response to disease assessment)?
O Recipient already in CR at start of preparative regimen (N/Apl)
O Yes, post-HSCT CR achieved
O No, never in CR from HSCT
O not evaluated
IF (79) Was a CR ever achieved in response to HSCT (including any therapy as of Day 0, excluding any change in
therapy in response to disease assessment)?:= Yes, post-HSCT CR achieved
THEN GOTO (80) Date post-HSCT CR achieved
ELSE GOTO (82) First relapse or progression after HSCT
IF (79) Was a CR ever achieved in response to HSCT (including any therapy as of Day 0, excluding any change in
therapy in response to disease assessment)?:= No, never in CR from HSCT
THEN GOTO (81) Date assessed:
ELSE GOTO (82) First relapse or progression after HSCT
80 Date:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO First CR date reported
previously
(answer is only valid on > d100 evaluation)

81 Date assessed:

First CR date reported previously (answer is only valid on >
d100 evaluation)
ELSE GOTO (82) First relapse or progression after HSCT

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO best response previously reported

Date of best response was previously reported
ELSE GOTO (82) First relapse or progression after HSCT

First Relapse or Progression After HSCT
(in this period, any type, not persistent disease)
82 First relapse or progression after HSCT
O yes
O no
IF (82) First relapse or progression after HSCT:= yes
THEN GOTO (83) Relapse/progression detected by molecular method:
ELSE GOTO (92) Additional treatment
If yes, answer all 3 methods. If used, give the date used and the results.
83 Relapse/progression detected by molecular method:
O yes
O no
O previously reported (answer is only valid on > d100 evaluation)
O not evaluated
IF (83) Relapse/progression detected by molecular method::= yes
THEN GOTO (84) Date first seen:
ELSE GOTO (86) Relapse/progression detected by cytogenetic/FISH method:
IF (83) Relapse/progression detected by molecular method::= no
THEN GOTO (85) Date of Assessment:
ELSE GOTO (86) Relapse/progression detected by cytogenetic/FISH method:
CIBMTR Form 2450 revision 3 (page 11 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 82-91

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

84 Date first seen:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (86) Relapse/progression detected by cytogenetic/FISH method:

85 Date of Assessment:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (86) Relapse/progression detected by cytogenetic/FISH method:

86 Relapse/progression detected by cytogenetic/FISH method:
O yes
O no
O previously reported (answer is only valid on > d100 evaluation)
O not evaluated
IF (86) Relapse/progression detected by cytogenetic/FISH method::= yes
THEN GOTO (87) Date first seen:
ELSE GOTO (89) Relapse/progression detected by clinical/hematological method:
IF (86) Relapse/progression detected by cytogenetic/FISH method::= no
THEN GOTO (88) Date of Assessment:
ELSE GOTO (89) Relapse/progression detected by clinical/hematological method:
87 Date first seen:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (89) Relapse/progression detected by clinical/hematological method:

88 Date of Assessment:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (89) Relapse/progression detected by clinical/hematological method:

89 Relapse/progression detected by clinical/hematological method:
O yes
O no
O previously reported (answer is only valid on > d100 evaluation)
O not evaluated
IF (89) Relapse/progression detected by clinical/hematological method::= yes
THEN GOTO (90) Date first seen:
ELSE GOTO (92) Additional treatment
IF (89) Relapse/progression detected by clinical/hematological method::= no
THEN GOTO (91) Date of Assessment:
ELSE GOTO (92) Additional treatment
90 Date first seen:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (92) Additional treatment

91 Date of Assessment:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (92) Additional treatment

Additional Treatment
92 Additional treatment
O yes
O no
IF (92) Additional treatment:= yes
THEN GOTO (93) DCI (allo only)
ELSE GOTO (96) Molecular *

CIBMTR Form 2450 revision 3 (page 12 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 92-95

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Specify:
93 DCI (allo only)
O yes Go to DCI section questions 110-122
O no
ELSE GOTO (94) Planned (given regardless of disease status/assessment post-HSCT)
94 Planned (given regardless of disease status/assessment post-HSCT)
O yes
O no
ELSE GOTO (95) Not planned (given for relapse, progression, or persistent disease)
95 Not planned (given for relapse, progression, or persistent disease)
O yes
O no
ELSE GOTO (96) Molecular *

Method of Latest Disease Assessment

Questions: 96-109

(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.
96 Molecular *
O yes
O no / not evaluated
IF (96) Molecular *:= yes
THEN GOTO (97) Disease detected?
ELSE GOTO (100) Cytogenetic/FISH *
97 Disease detected?
O yes
O no
IF (97) Disease detected?:= yes
THEN GOTO (98) Status considered disease relapse or progression?
ELSE GOTO (99) Date latest assessed:
98 If yes, was the status considered a disease relapse or progression?
O yes
O no
ELSE GOTO (99) Date latest assessed:
99 Date latest assessed:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (100) Cytogenetic/FISH *

100 Cytogenetic/FISH *
O yes
O no / not evaluated
IF (100) Cytogenetic/FISH *:= yes
THEN GOTO (101) Disease detected?
ELSE GOTO (104) Clinical/Hematologic
101 Disease detected?
O yes
O no
IF (101) Disease detected?:= yes
THEN GOTO (102) If yes, was the status considered a disease relapse or progression?
ELSE GOTO (103) Date latest assessed:
102 If yes, was the status considered a disease relapse or progression?
O yes
O no
ELSE GOTO (103) Date latest assessed:
CIBMTR Form 2450 revision 3 (page 13 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

103 Date latest assessed:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (104) Clinical/Hematologic

104 Clinical/Hematologic
O yes
O no / not evaluated
IF (104) Clinical/Hematologic:= yes
THEN GOTO (105) Disease detected?
ELSE GOTO (107) Previous transplant performed for another disease?
105 Disease detected?
O yes
O no
ELSE GOTO (106) Date latest assessed:
106 Date latest assessed:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
ELSE GOTO (107) Previous transplant performed for another disease?

107 Was a previous HSCT performed for a different disease than this HSCT?
O yes
O no
IF (107) Previous transplant performed for another disease?:= no AND (93) DCI (allo only):= yes
THEN GOTO (110) Date of DCI:
ELSE GOTO (108) Status of original disease
IF (107) Previous transplant performed for another disease?:= yes AND (93) DCI (allo only):= no
THEN GOTO (108) Status of original disease
ELSE GOTO End of Form
108 Give status of original disease
O CR
O Not in CR
ELSE GOTO (109) Date determined
109 Date determined

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
IF (109) Date determined:= EXISTS AND (93) DCI (allo only):= Y
THEN GOTO (110) Date of DCI:
ELSE GOTO End of Form

Donor Cellular Infusion (DCI)
Donor Cellular Infusion (DCI)
Post Ted DCI
110 Date of DCI:

__ __ __ __ - __ __ - __ __
YYYY
MM
DD
IF (110) Date of DCI::= EXISTS
THEN GOTO (111) Total #DCI in 10 weeks
ELSE GOTO End of Form

111 Total #DCI in 10 weeks ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
ELSE GOTO (112) Lymphocytes
Type of cell(s) (check all that apply):
112 Lymphocytes
O yes
O no
ELSE GOTO (113) Fibroblasts
CIBMTR Form 2450 revision 3 (page 14 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.

Questions: 110-122
Questions: 110-121

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

113 Fibroblasts
O yes
O no
ELSE GOTO (114) Dendritic cells
114 Dendritic cells
O yes
O no
ELSE GOTO (115) Mesenchymal
115 Mesenchymal
O yes
O no
ELSE GOTO (116) Other
116 Other
O yes
O no
IF (116) Other:= yes
THEN GOTO (117) Specify:
ELSE GOTO (118) Indication:
117 Specify: ________________________
ELSE GOTO (118) Indication:
118 Indication:
O Planned
O Treat disease
O Treat PTLD, EBV-Lym
O Treat viral
O Treat GVHD
O Mixed Chimerism
O Loss/Decreased Chimerism
O Other
IF (118) Indication::= Other
THEN GOTO (119) Specify:
ELSE GOTO (120) Maximum Grade of Acute Graft Versus Host Disease (GVHD):
119 Specify: ________________________
ELSE GOTO (120) Maximum Grade of Acute Graft Versus Host Disease (GVHD):
120 Maximum Grade of Acute Graft Versus Host Disease (GVHD):
O 0
O I
O II
O III
O IV
O unknown
ELSE GOTO (121) If another DCI was received in this reporting period, disease status before next DCI:
121 If another DCI was received in this reporting period, disease status before next DCI:
O CR
O Not in CR
O Not assessed
ELSE GOTO (122) Were there more than 3 instances of DCI infusions in this reporting period?
Copy questions 110-121 if needed for Donor Cellular Infusion (DCI)
122 Were there more than 3 instances of DCI infusions in this reporting period?
O yes
O no
ELSE GOTO End of Form
CIBMTR Form 2450 revision 3 (page 15 of 15) Last Updated November 12, 2012.
Copyright (c) 2012 National Marrow Donor Program and
The Medical College of Wisconsin, Inc. All rights reserved.


File Typeapplication/pdf
AuthorAndrey Protas
File Modified2012-12-04
File Created2012-12-04

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