Draft 2400 r5 - Pre-TED (split-track changes

Draft 2400 r5 - Pre-TED (split-track changes).docx

Stem Cell Therapeutic Outcomes Database

Draft 2400 r5 - Pre-TED (split-track changes

OMB: 0915-0310

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Pre-Transplant Essential Data

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(Request for OMB approval will be submitted when form is complete)OMB Placeholder

OMB No: 0915-0310

Expiration Date:


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.


CIBMTR Use Only

Sequence Number:





Date Received:





Center Identification

CIBMTR Center Number: ___ ___ ___ ___ ___

EBMT Code (CIC): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Hospital:

Unit: (check only one)

Adult

Pediatric



Recipient Identification

CIBMTR Research ID (CRID): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

























Recipient Data

  1. Date of birth: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Sex:

Male

Female

  1. Ethnicity:

Hispanic or Latino

Not Hispanic or Latino

Not applicable (not a resident of the USA)

Unknown

  1. Race:

White

Black or African American

Asian

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Not reported

Unknown

Copy question 4 to report more than one race.

  1. Zip or postal code for place of recipient’s residence (USA recipients only): ___ ___ ___ ___ ___

  2. Is the recipient participating in a clinical trial?

Yes - Go to question 7

No – Go to question 11

  1. Study Sponsor:

 BMT-CTN – Go to question 9

 RCI-BMT – Go to question 9

 USIDNET – Go to question 10

 COG – Go to question 10

 Other sponsor – Go to question 8

  1. Specify other sponsor: ________________________________ - Go to question 10

  2. Study ID Number: _______

  3. Subject ID: ______________________

Copy questions 7-10 to report participation in more than one study.

Hematopoietic Cellular Transplant (HCT)

  1. Date of this HCT: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Was this the first HCT for this recipient?

Yes – Go to question 13

No – Go to question 15

  1. Is a subsequent HCT planned as part of the overall treatment protocol (not as a reaction to post-HCT disease assessment)? (For autologous HCTs only)

Yes – Go to question 14

No – Go to question 29

  1. Specify subsequent HCT planned:

Autologous – Go to question 29

Allogeneic – Go to question 29

  1. Specify the number of prior HCTs: ___ ___

Specify the HSC source(s) for all prior HCTs:

  1. Autologous

Yes

No

  1. Allogeneic, unrelated

Yes

No

  1. Allogeneic, related

Yes

No

  1. Syngeneic

Yes

No

  1. Date of the last HCT (just before current HCT): ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Was the last HCT performed at a different institution?

Yes – Go to question 22

No – Go to question 23



Specify the institution that performed the last HCT:

  1. Name:

City:

State:

Country:

  1. What was the HSC source for the last HCT?

Autologous

Allogeneic, unrelated donor

Allogeneic, related donor

  1. Reason for current HCT:

No hematopoietic recovery – Go to question 29

Partial hematopoietic recovery – Go to question 29

Graft failure / rejection after achieving initial hematopoietic recovery – Go to question 25

Persistent primary disease – Go to question 29

Recurrent primary disease – Go to question 26

Planned second HCT, per protocol – Go to question 29

New malignancy (including PTLD and EBV lymphoma) – Go to question 27

Stable, mixed chimerism – Go to question 29

Declining chimerism – Go to question 29

Other – Go to question 28

  1. Date of graft failure / rejection: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

  1. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

  1. Date of secondary malignancy: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 29

YYYY MM DD

  1. Specify other reason:

Donor Information

  1. Multiple donors?

Yes – Go to question 30

No - Go to question 31

  1. Specify number of donors: ___ ___



To report more than one donor, copy questions 31- 63 and complete for each donor.

  1. Specify donor:

Autologous - Go to question 46

Autologous cord blood unit - Go to question 35

NMDP unrelated cord blood unit - Go to question 32

NMDP unrelated donor - Go to question 33

Related donor - Go to question 40

Related cord blood unit - Go to question 35

Non-NMDP unrelated donor - Go to question 34

Non-NMDP unrelated cord blood unit - Go to question 35

  1. NMDP cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ – Go to question 46

  2. NMDP donor ID: ___ ___ ___ ___ — ___ ___ ___ ___ — ___ Go to question 46

  3. Non-NMDP unrelated donor ID: (not applicable for related donors)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 38

  1. Non-NMDP cord blood unit ID: (include related and autologous CBUs)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

  1. Is the CBU ID also the ISBT DIN number?

 Yes – Go to question 38

No – Go to question 37

  1. Specify the ISBT DIN number: ____________________________________

  2. Registry or UCB Bank ID: ___ ___ ___ ___ - If ‘Other registry’ go to 39, otherwise go to question 41

  3. Specify other Registry or UCB Bank: - Go to question 41

  4. Specify the related donor type:

Syngeneic (monozygotic twin)

HLA-identical sibling (may include non-monozygotic twin)

HLA-matched other relative

HLA-mismatched relative

  1. Date of birth: (donor / infant)

Known – Go to question 42

Unknown – Go to question 43

  1. Date of birth: (donor / infant) ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 45

YYYY MM DD

  1. Age: (donor / infant)

Known – Go to question 44

Unknown – Go to question 45

  1. Age: (donor / infant) ___ ___ Months (use only if less than 1 year old)

Years

  1. Sex: (donor / infant)

Male

Female

Specify product type:

  1. Bone marrow:

Yes

No

  1. PBSC:

Yes

No

  1. Single cord blood unit:

Yes

No

  1. Other product:

Yes – Go to question 50

No – Go to question 51

  1. Specify other product type:

A series of collections should be considered a single product when they are all from the same donor and use the same collection method and technique (and mobilization, if applicable), even if the collections are performed on different days.

  1. Specify number of products infused from this donor: ___ ___

  1. Specify the number of these products intended to achieve hematopoietic engraftment: ___ ___

Questions 53 – 60 are for autologous HCT recipients only. If other than autologous skip to question 61

  1. Did the recipient have more than one mobilization event to acquire cells for HCT?

Yes – Go to question 54

 No – Go to question 55

  1. Specify the total number of mobilization events performed for this HCT (regardless of the number of collections or which collections were used for this HCT): ___

Specify all agents used in the mobilization events reported above:

  1. G-CSF

Yes

No

  1. GM-CSF

Yes

No

  1. Pegylated G-CSF

Yes

No

  1. Plerixafor (Mozobil)

Yes

No

  1. Other CXCR4 inhibitor

Yes

No

  1. Combined with chemotherapy:

Yes

No

  1. Was this donor used for any prior HCTs?

Yes

No

  1. Donor CMV-antibodies (IgG or Total) (Allogeneic HCTs only)

Reactive

Non-reactive

Not done

 Not applicable (cord blood unit)

  1. Was plerixafor (Mozobil) given at any time prior to the preparative regimen? (Related HCTs only)

Yes

No

Unknown



Consent

  1. Has the recipient signed an IRB-approved consent form for submitting research data to the NMDP / CIBMTR?

Yes (patient consented) – Go to question 65

No (patient declined) – Go to question 66

Not approached – Go to question 66

  1. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Did the recipient give permission to be directly contacted for future research?

Yes (patient provided permission) – Go to question 67

No (patient declined) – Go to question 68

Not approached - Go to question 68

  1. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Has the recipient signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR?

Yes (patient consented) – Go to question 69

No (patient declined) - Go to question 70

Not approached - Go to question 70

Not applicable (center not participating) - Go to question 70

  1. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Has the donor signed an IRB-approved consent form to donate research blood samples to the NMDP / CIBMTR? (Allogeneic donors only)

Yes (donor consented) – Go to question 71

No (donor declined) - Go to question 72

Not approached - Go to question 72

Not applicable (center not participating) - Go to question 72

  1. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD



Product Processing / Manipulation

  1. Was the product manipulated prior to infusion?

Yes - Go to questions 73

No - Go to question 91

  1. Specify portion manipulated:

Entire product

Portion of product

Specify all methods used to manipulate the product:

  1. Washed

Yes

No

  1. Diluted

Yes

No

  1. Buffy coat enriched (buffy coat preparation)

Yes

No

  1. B-cell reduced

Yes

No

  1. CD8 reduced

Yes

No

  1. Plasma reduced (removal)

Yes

No

  1. RBC reduced

Yes

No

  1. Cultured (ex-vivo expansion)

Yes

No

  1. Genetic manipulation (gene transfer / transduction)

Yes

No

  1. PUVA treated

Yes

No

  1. CD34 enriched (CD34+ selection)

Yes

No

  1. CD133 enriched

Yes

No

  1. Monocyte enriched

Yes

No

  1. Mononuclear cells enriched

Yes

No

  1. T-cell depletion

Yes

No

  1. Other cell manipulation

Yes - Go to question 90

No - Go to question 91

  1. Specify other cell manipulation:



Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

  1. What scale was used to determine the recipient’s functional status?

Karnofsky (recipient age ≥ 16 years) – Go to question 92

Lansky (recipient age < 16 years) – Go to question 93

Performance score prior to the preparative regimen:

  1. Karnofsky Scale (recipient age ≥ 16 years):

 100 Normal; no complaints; no evidence of disease - Go to question 94

 90 Able to carry on normal activity - Go to question 94

 80 Normal activity with effort - Go to question 94

 70 Cares for self; unable to carry on normal activity or to do active work - Go to question 94

 60 Requires occasional assistance but is able to care for most needs - Go to question 94

 50 Requires considerable assistance and frequent medical care - Go to question 94

 40 Disabled; requires special care and assistance - Go to question 94

 30 Severely disabled; hospitalization indicated, although death not imminent - Go to question 94

 20 Very sick; hospitalization necessary - Go to question 94

10 Moribund; fatal process progressing rapidly - Go to question 94

  1. Lansky Scale (recipient age < 16 years):

 100 Fully active

 90 Minor restriction in physically strenuous play

 80 Restricted in strenuous play, tires more easily, otherwise active

 70 Both greater restrictions of, and less time spent in, active play

 60 Ambulatory up to 50% of time, limited active play with assistance / supervision

 50 Considerable assistance required for any active play; fully able to engage in quiet play

 40 Able to initiate quiet activities

 30 Needs considerable assistance for quiet activity

 20 Limited to very passive activity initiated by others (e.g., TV)

10 Completely disabled, not even passive play

  1. Recipient CMV-antibodies (IgG or Total) :

Reactive

Non-reactive

Not done

Comorbid Conditions

  1. Is there a history of mechanical ventilation?

Yes

No

  1. Is there a history of proven invasive fungal infection?

Yes

No

  1. Were there clinically significant co-existing diseases or organ impairment at time of patient assessment prior to preparative regimen? Source: Blood, 2005 Oct 15;106(8):2912-2919

Yes - Go to questions 98

No - Go to question 135

  1. Arrhythmia — For example, any history of atrial fibrillation or flutter, sick sinus syndrome, or ventricular arrhythmias requiring treatment

Yes

No

Unknown

  1. Cardiac — Any history of coronary artery disease (one or more vessel-coronary artery stenosis requiring medical treatment, stent, or bypass graft), congestive heart failure, myocardial infarction, OR ejection fraction ≤ 50% on the most recent test

Yes

No

Unknown

  1. Cerebrovascular disease — Any history of transient ischemic attack, subarachnoid hemorrhage or cerebrovascular accident

Yes

No

Unknown

  1. Diabetes — Requiring treatment with insulin or oral hypoglycemics in the last 4 weeks but not diet alone

Yes

No

Unknown

  1. Heart valve disease — Except asymptomatic mitral valve prolapse

Yes

No

Unknown

  1. Hepatic, mild — Chronic hepatitis, bilirubin > upper limit of normal to 1.5 × upper limit of normal, or AST/ALT > upper limit of normal to 2.5 × upper limit of normal at the time of transplant OR any history of hepatitis B or hepatitis C infection

Yes

No

Unknown

  1. Hepatic, moderate / severe — Liver cirrhosis, bilirubin > 1.5 × upper limit of normal, or AST/ALT > 2.5 × upper limit of normal

Yes

No

Unknown

  1. Infection — For example, documented infection, fever of unknown origin, or pulmonary nodules requiring continuation of antimicrobial treatment after day 0

Yes

No

Unknown

  1. Inflammatory bowel disease — Any history of Crohn’s disease or ulcerative colitis requiring treatment

Yes

No

Unknown

  1. Obesity — Patients with a body mass index > 35 kg/m2 at time of transplant

Yes

No

Unknown

  1. Peptic ulcer — Any history of peptic ulcer confirmed by endoscopy and requiring treatment

Yes

No

Unknown

  1. Psychiatric disturbance — For example, depression, anxiety, bipolar disorder or schizophrenia requiring psychiatric consult or treatment in the last 4 weeks

Yes

No

Unknown

  1. Pulmonary, moderate — Corrected diffusion capacity of carbon monoxide and/or FEV1 66-80% or dyspnea on slight activity at transplant

Yes

No

Unknown

  1. Pulmonary, severe — Corrected diffusion capacity of carbon monoxide and/or FEV1 ≤ 65% or dyspnea at rest or requiring oxygen at transplant

Yes

No

Unknown

  1. Renal, moderate / severe — Serum creatinine > 2 mg/dL or > 177 μmol/L or on dialysis at transplant, OR prior renal transplantation

Yes

No

Unknown

  1. Rheumatologic — For example, any history of systemic lupus erythmatosis, rheumatoid arthritis, polymyositis, mixed connective tissue disease, or polymyalgia rheumatica requiring treatment (do NOT include degenerative joint disease, osteoarthritis)

Yes

No

Unknown

  1. Solid tumor, prior — Treated at any time point in the patient’s past history, excluding non-melanoma skin cancer, leukemia, lymphoma or multiple myeloma

Yes – Go to question 115

No – Go to question 133

Unknown – Go to question 133

  1. Breast cancer

Yes – Go to question 116

No – Go to question 117

  1. Year of diagnosis: ___ ___ ___ ___

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

Yes – Go to question 118

No – Go to question 119

  1. Year of diagnosis: ___ ___ ___ ___

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

Yes – Go to question 120

No – Go to question 121

  1. Year of diagnosis: ___ ___ ___ ___

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

Yes – Go to question 122

No – Go to question 123

  1. Year of diagnosis: ___ ___ ___ ___

  2. Lung cancer

Yes – Go to question 124

No – Go to question 125

  1. Year of diagnosis: ___ ___ ___ ___

  2. Melanoma

Yes – Go to question 126

No – Go to question 127

  1. Year of diagnosis: ___ ___ ___ ___

  2. Oropharyngeal cancer (tongue, buccal mucosa)

Yes – Go to question 128

No – Go to question 129

  1. Year of diagnosis: ___ ___ ___ ___

  2. Sarcoma

Yes – Go to question 130

No – Go to question 131

  1. Year of diagnosis: ___ ___ ___ ___

  2. Thyroid cancer

Yes – Go to question 132

No – Go to question 133

  1. Year of diagnosis: ___ ___ ___ ___

  2. Other co-morbid condition

Yes – Go to question 134

No – Go to question 135

Unknown – Go to question 135

  1. Specify other co-morbid condition:



  1. Was there a history of malignancy (hematologic or non-melanoma skin cancer) other than the primary disease for which this HCT is being performed?

Yes – Go to question 136

No – Go to question 156

Specify which malignancy(ies) occurred:

  1. Acute myeloid leukemia (AML / ANLL)

Yes – Go to question 137

No – Go to question 138

  1. Year of diagnosis: ___ ___ ___ ___

  2. Other leukemia, including ALL

Yes – Go to questions 139

No – Go to question 141

  1. Year of diagnosis: ___ ___ ___ ___

  2. Specify leukemia:

  3. Clonal cytogenetic abnormality without leukemia or MDS

Yes – Go to question 142

No – Go to question 143

  1. Year of diagnosis: ___ ___ ___ ___

  2. Hodgkin disease

Yes – Go to question 144

No – Go to question 145

  1. Year of diagnosis: ___ ___ ___ ___

  2. Lymphoma or lymphoproliferative disease

Yes – Go to questions 146

No – Go to question 148

  1. Year of diagnosis: ___ ___ ___ ___

  2. Was the tumor EBV positive?

Yes

No

  1. Other skin malignancy (basal cell, squamous)

Yes – Go to questions 149

No – Go to question 151

  1. Year of diagnosis: ___ ___ ___ ___

  2. Specify other skin malignancy:

  3. Myelodysplasia (MDS) / myeloproliferative (MPN) disorder

Yes – Go to question 152

No – Go to question 153

  1. Year of diagnosis: ___ ___ ___ ___

  2. Other prior malignancy

Yes – Go to questions 154

No – Go to question 155

  1. Year of diagnosis: ___ ___ ___ ___

  2. Specify other prior malignancy:





Pre-HCT Preparative Regimen (Conditioning)

  1. Height at initiation of pre-HCT preparative regimen: ___ ___ ___ inches

centimeters

  1. Actual weight at initiation of pre-HCT preparative regimen: ___ ___ ___ pounds

kilograms

  1. Was a pre-HCT preparative regimen prescribed?

Yes – Go to questions 159

No – Go to question 317

  1. Classify the recipient’s prescribed preparative regimen:

Myeloablative

Non-myeloablative (NST)

Reduced intensity (RIC)

  1. Date pre-HCT preparative regimen began (irradiation or drugs): ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

(Use earliest date from questions 164 radiation, or 169 – 316 chemotherapy)

  1. Was irradiation planned as part of the pre-HCT preparative regimen?

Yes – Go to question 162

No – Go to question 169

  1. What was the prescribed radiation field?

Total body

Total body by tomotherapy

Total lymphoid or nodal regions

Thoracoabdominal region

  1. Total prescribed dose: (dose per fraction x total number of fractions) ___ ___ ___ ___ Gy

cGy

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Was the radiation fractionated?

Yes – Go to questions 166

No – Go to question 169

  1. Prescribed dose per fraction: ___ ___ ___ Gy

cGy

  1. Number of days: (include “rest” days) ___

  2. Total number of fractions: ___ ___

Indicate the total prescribed cumulative dose for the preparative regimen:

  1. ALG, ALS, ATG, ATS

Yes – Go to questions 170

No – Go to question 174

  1. Total prescribed dose ___ ___ ___ ___ mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify source:

ATGAM (horse) – Go to question 174

ATG – Fresenius (rabbit) – Go to question 174

Thymoglobulin (rabbit) – Go to question 174

Other – Go to question 173

  1. Specify other source:

  2. Anthracycline

Yes – Go to question 175

No – Go to question 191

  1. Daunorubicin

Yes – Go to questions 176

No – Go to question 178

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Doxorubicin (Adriamycin)

Yes – Go to questions 179

No – Go to question 181

  1. Total prescribed dose: ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Idarubicin

Yes – Go to questions 182

No – Go to question 184

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Rubidazone

Yes – Go to questions 185

No – Go to question 187

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other anthracycline

Yes – Go to questions 188

No – Go to question 191

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other anthracycline:

  2. Bleomycin (BLM, Blenoxane)

Yes – Go to questions 192

No – Go to question 194

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Busulfan (Myleran)

Yes – Go to questions 195

No – Go to question 198

  1. Total prescribed dose ___ ___ ___ ___ ___ mg/m2

mg/kg

Target total AUC (µmol x min/L)

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify administration:

Oral

IV

Both

  1. Carboplatin

Yes – Go to questions 199

No – Go to question 203

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Were pharmacokinetics performed to determine preparative regimen drug dosing?

Yes – Go to question 202

No – Go to question 203

  1. Specify the target AUC: ___ ___ ___mg/mL/minute

  2. Cisplatin (Platinol, CDDP)

Yes – Go to questions 204

No – Go to question 206

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Cladribine (2-CdA, Leustatin)

Yes – Go to questions 207

No – Go to question 209

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Corticosteroids (excluding anti-nausea medication)

Yes – Go to question 210

No – Go to question 223

  1. Methylprednisolone (Solu-Medrol)

Yes – Go to questions 211

No – Go to question 213

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Prednisone

Yes – Go to questions 214

No – Go to question 216

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Dexamethasone

Yes – Go to questions 217

No – Go to question 219

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other corticosteroid

Yes – Go to questions 220

No – Go to question 223

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other corticosteroid:

  2. Cyclophosphamide (Cytoxan)

Yes – Go to questions 224

No – Go to question 226

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Cytarabine (Ara-C)

Yes – Go to questions 227

No – Go to question 229

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Etoposide (VP-16, VePesid)

Yes – Go to questions 230

No – Go to question 232

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Fludarabine

Yes – Go to questions 233

No – Go to question 235

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Ifosfamide

Yes – Go to questions 236

No – Go to question 238

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Intrathecal therapy (chemotherapy)

Yes – Go to question 239

No – Go to question 252

  1. Intrathecal cytarabine (IT Ara-C)

Yes – Go to questions 240

No – Go to question 242

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Intrathecal methotrexate (IT MTX)

Yes – Go to questions 243

No – Go to question 245

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Intrathecal thiotepa

Yes – Go to questions 246

No – Go to question 248

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other intrathecal drug

Yes – Go to questions 249

No – Go to question 252

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other intrathecal drug:

  2. Melphalan (L-Pam)

Yes – Go to questions 253

No – Go to question 256

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify administration:

Oral

IV

Both

  1. Mitoxantrone (Novantrone)

Yes – Go to questions 257

No – Go to question 259

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Monoclonal antibody

Yes – Go to question 260

No – Go to question 280

  1. Radio labeled mAb

Yes – Go to questions 251

No – Go to question 267

  1. Total prescribed dose of radioactive component: ___ ___ ___ ___ ● ___ mCi

MBq

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Specify radio labeled mAb:

  1. Tositumomab (Bexxar)

Yes

No

  1. Ibritumomab tiuxetan (Zevalin)

Yes

No

  1. Other radio labeled mAb

Yes – Go to question 266

No – Go to question 267

  1. Specify other radio labeled mAb:

  2. Alemtuzumab (Campath)

Yes – Go to questions 268

No – Go to question 270

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Rituximab (Rituxan, anti CD20)

Yes – Go to questions 271

No – Go to question 273

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Gemtuzumab (Mylotarg, anti CD33)

Yes – Go to questions 274

No – Go to question 276

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other mAb

Yes – Go to questions 277

No – Go to question 280

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other mAb:

  2. Nitrosourea

Yes – Go to question 281

No – Go to question 291

  1. Carmustine (BCNU)

Yes – Go to questions 282

No – Go to question 284

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. CCNU (Lomustine)

Yes – Go to questions 285

No – Go to question 287

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other nitrosourea

Yes – Go to questions 288

No – Go to question 291

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other nitrosourea:

  2. Paclitaxel (Taxol, Xyotax)

Yes – Go to questions 292

No – Go to question 294

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Teniposide (VM26)

Yes – Go to questions 295

No – Go to question 297

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Thiotepa

Yes – Go to questions 298

No – Go to question 300

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Treosulfan

Yes – Go to questions 301

No – Go to question 303

  1. Total prescribed dose ___ ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Tyrosine kinase inhibitors

Yes – Go to questions 304

No – Go to question 313

  1. Dasatinib (Sprycel)

Yes – Go to questions 305

No – Go to question 307

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Imatinib mesylate (STI571, Gleevec)

Yes – Go to questions 308

No – Go to question 310

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Nilotinib

Yes – Go to questions 311

No – Go to question 313

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Other drug

Yes – Go to questions 314

No – Go to question 317

  1. Total prescribed dose ___ ___ ___ ___ mg/m2

mg/kg

  1. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

  1. Specify other drug:



GVHD Prophylaxis

This section is to be completed for allogeneic HCTs only; autologous HCTs continue with question 344.

  1. Was GVHD prophylaxis planned / given?

Yes - Go to questions 318

No - Go to question 344

Specify:

  1. ALG, ALS, ATG, ATS

Yes – Go to question 319

No – Go to question 322

  1. Total dose: ___ ___ ___ ___ ___ mg/kg

  2. Specify source:

ATGAM (horse) – Go to question 322

ATG – Fresenius (rabbit) – Go to question 3212

Thymoglobulin (rabbit) – Go to question 322

Other – Go to question 321

  1. Specify other source:

  2. Corticosteroids (systemic)

Yes

No

  1. Cyclosporine (CSA, Neoral, Sandimmune)

Yes

No

  1. Cyclophosphamide (Cytoxan)

Yes

No

  1. Extra-corporeal photopheresis (ECP)

Yes

No

  1. FK 506 (Tacrolimus, Prograf)

Yes

No

  1. In vivo monoclonal antibody

Yes – Go to question 328

No – Go to question 335

Specify in vivo monoclonal antibody:

  1. Alemtuzumab (Campath)

Yes

No

  1. Anti CD 25 (Zenapax, Daclizumab, AntiTAC)

Yes – Go to question 330

No – Go to question 331

  1. Specify:

  2. Etanercept (Enbrel)

Yes

No

  1. Infliximab (Remicade)

Yes

No

  1. Other in vivo monoclonal antibody

Yes – Go to question 334

No – Go to question 335

  1. Specify antibody:

  2. In vivo immunotoxin

Yes – Go to question 336

No – Go to question 337

  1. Specify immunotoxin:

  2. Methotrexate (MTX) (Amethopterin)

Yes

No

  1. Mycophenolate mofetil (MMF) (CellCept)

Yes

No

  1. Sirolimus (Rapamycin, Rapamune)

Yes

No

  1. Blinded randomized trial

Yes – Go to question 341

No – Go to question 342

  1. Specify trial agent:

  2. Other agent

Yes – Go to question 343

No – Go to question 344

  1. Specify other agent:

Other Toxicity Modifying Regimen

Optional for non-U.S. Centers

  1. Was KGF (palifermin, Kepivance) started or is there a plan to use it?

Yes

No

Masked trial

Post-HCT Disease Therapy Planned as of Day 0

  1. Is this HCT part of a planned multiple (sequential) graft / HCT protocol?

Yes

No

  1. Is additional post-HCT therapy planned?

Yes - Go to questions 347

No - Go to First Name

Questions 347 – 357 are optional for non-U.S. centers

  1. Bortezomib (Velcade)

Yes

No

  1. Cellular therapy (e.g. DCI, DLI)

Yes

No

  1. Dexamethasone

Yes

No

  1. Intrathecal therapy (chemotherapy)

Yes

No

  1. Tyrosine kinase inhibitor (e.g. imatinib mesylate)

Yes

No

  1. Lenalidomide (Revlimid)

Yes

No

  1. Local radiotherapy

Yes

No

  1. Rituximab (Rituxan, MabThera)

Yes

No

  1. Thalidomide (Thalomid)

Yes

No

  1. Other therapy

Yes – Go to question 357

No – Go to First Name

  1. Specify other therapy:





First Name: ____________________________________________________________________________



Last Name:

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2400 revision 5 (page 1 of 49) Draft 6/19/2016


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