Gene Therapy Manuals

Getting Started
- Manual Reference Diagram
- Providing Feedback
- Historical Manual Updates
General Instructions
- Introduction
- Key Fields & Signature Lines
- General Guidelines for Completing Forms
Recipient Assignment, Indication, and Information Manuals
- 2804: CIBMTR Research ID Assignment Form
- 2814: Indication for CIBMTR Data Reporting
- 2820: Recipient Contact Information
Transplant Essential Data (TED) Manuals
- 2400: Pre-TED
- 2402: Disease Classification
- 2450: Post-TED
Comprehensive Baseline & Follow-up Manuals
- 2000: Recipient Baseline
- 2004: Infectious Disease Markers
  - Q1: Donor/Cord Blood Unit Identification
  - Q2 – 29: Infectious Disease Markers
- 2005: Confirmation of HLA Typing
- 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion
- 2100: Post-Infusion Follow-Up
Comprehensive Disease-Specific Manuals
- 2010/2110: Acute Myelogenous Leukemia (AML)
  - AML Response Criteria
  - 2010: AML Pre-Infusion
  - 2110: AML Post-Infusion
- 2011/2111: Acute Lymphoblastic Leukemia (ALL)
  - ALL Response Criteria
  - 2011: ALL Pre-Infusion
  - 2111: ALL Post-Infusion
- 2012/2112: Chronic Myeloid Leukemia (CML)
  - CML Response Criteria
  - 2012: CML Pre-Infusion Data
  - 2112: CML Post-Infusion Data
- 2013/2113: Chronic Lymphocytic Leukemia (CLL)
  - CLL Response Criteria
  - 2013: CLL Pre-Infusion
  - 2113: CLL Post-Infusion
- 2014/2114: Myelodysplastic Syndrome (MDS)
  - MDS Response Criteria
  - 2014: Myelodysplastic Syndrome (MDS) Pre-Infusion
  - 2114: Myelodysplastic Syndrome (MDS) Post-Infusion
- 2015/2115: Juvenile Myelomonocytic Leukemia (JMML)
  - JMML Response Criteria
  - 2015: JMML Pre-HCT
  - 2115: JMML Post HCT
- 2016/2116: Plasma Cell Disorders (PCD)
  - Multiple Myeloma Response Criteria
  - Plasma Cell Leukemia Response Criteria
  - POEMS Response Criteria
  - Amyloidosis Response Criteria
    - New York Heart Association Function Classifications
  - 2016: PCD Pre-Infusion
  - 2116: PCD Post-Infusion
- 2018/2118: Hodgkin and Non-Hodgkin Lymphoma
  - Lymphoma Response Criteria
  - 2018: LYM Pre-Infusion
  - 2118: LYM Post-Infusion
- 2019/2119: Waldenström’s Macroglobulinemia (WM)
  - Waldenstrom’s Macroglobulinemia Response Criteria
  - 2019: WM Pre-HCT
  - 2119: WM Post-HCT
- 2026/2126: Neuroblastoma
  - Neuroblastoma Response Criteria
  - 2026: Neuroblastoma Pre-Infusion
  - 2126: Neuroblastoma Post-Infusion
    - Q1 – 159: Disease Assessments at Time of Best Response to HSCT
- 2028/2128: Aplastic Anemia
  - 2028: Aplastic Anemia Pre-Infusion
  - 2128: Aplastic Anemia Post-HCT
    - Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period
- 2029/2129: Fanconi Anemia / Constitutional Anemia
  - 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT
  - 2129: Fanconi Anemia / Constitutional Anemia Post-HCT
    - Q1 – 6: Current Hematologic Parameters
- 2030/2130: Sickle Cell Disease (SCD)
  - 2030: SCD Pre-Infusion
  - 2130: SCD Post-Infusion
- 2031/2131: Immune Deficiencies (ID)
  - 2031: ID Pre-HCT
  - 2131: ID Post-HCT
- 2033/2133: Wiskott-Aldrich Syndome (WAS)
  - 2033: WAS Pre-HCT
  - 2133: WAS Post-HCT
- 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)
  - 2034: XLP Pre-HCT
  - 2134: XLP Post-HCT
- 2037 / 2137 Leukodystrophies
  - 2037: Leukodystrophies Pre-Infusion
  - 2137: Leukodystrophies Post-Infusion
- 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH)
  - 2039: HLH Pre-HCT
  - 2139: HLH Post-HCT
    - Q1-32: Disease Assessment Since the Date of Last Report
- 2057/2157 Myeloproliferative Neoplasms (MPN)
  - MPN Response Criteria
  - 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion
  - 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion
- 2058/2158: Thalassemia
  - 2058: Thalassemia Pre-Infusion
  - 2158: Thalassemia Post-Infusion
Cellular Therapy Manuals
- 4000: Cellular Therapy Essential Data Pre-Infusion
- 4001: Pre-Cellular Therapy Baseline Data
- 4003: Cellular Therapy Product
- 4006: Cellular Therapy Infusion
  - Q1-31: Product Identification
  - Q32-35: Concomitant Therapy
- 4100: Cellular Therapy Essential Data Follow-Up
- 4101: Post-Cellular Therapy Follow-Up
Gene Therapy Manuals
- 2003: Gene Therapy Product
- 2103: Persistence of Gene Therapy Product
  - Q1 – 18: Persistence of Gene Therapy Product
Infection & Miscellaneous Manuals
- 2046 / 2146: Fungal Infection
  - 2046: Fungal Infection Pre-Infusion Data
    - Q1-25: Infection Episode
    - Q26-31: Treatment of Infection
  - 2146: Fungal Infection Post-Infusion Data
- 2047 / 2147: Hepatitis Serology
  - 2047: Hepatitis Serology Pre-HCT
  - 2147: Hepatitis Serology Post-HCT
- 2149: Respiratory Virus Post-Infusion Data
- 2150: Viral Infection Diagnosis and Treatment Form
- 2199 Donor Lymphocyte Infusion
  - Q1-34: Donor Lymphoctye Infusion (DLI)
- 2553: VOD/SOS
- 2900: Recipient Death
  - Q1-7: Recipient Death Data
  - Cause of Death Codes
- 3500: Subsequent Neoplasms
  - Q1 – 12: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
  - Q13 – 24: Post-Transplant Lymphoproliferative Disorder
- 3501: Pregnancy Form
  - Q1-6: Functional Status
Study-Specific Manuals
- 2540: Tepadina® Supplemental Data
- 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data
  - Q1-17: Inotuzumab Ozogamicin (Besponsa™)
- 2542: Mogamulizumab Supplemental Data Collection
  - Q1 – 3: Complications of Interest
  - Q4 – 12: Post-Infusion Critical Illness
- 2543: Mylotarg™ Supplemental Data Collection
  - Gemtuzumab ozogamicin (Mylotarg™) Administration Pre – HCT / Pre-Infusion
- 2555: MF Eligibility
  - Q1-4: Inclusion Criteria
  - Q5-7: Exclusion Criteria
- 2565: Sanofi Mozobil Supplemental Data
Appendices
- Appendix A: Abbreviations and Definitions
- Appendix B: Glossary of Terms
- Appendix C: Cytogenetics
- Appendix D: How to Distinguish Infusion Types
- Appendix E: Definition of a Product
- Appendix F: Response Evaluation Criteria in Solid Tumors (RECIST)
- Appendix G: Tracking Disease Status for Multiple Myeloma
- Appendix I: Ethnicity and Race
- Appendix J: Reporting Comorbidities
- Appendix L: Karnofsky/Lansky Performance Status
- Appendix N: Drug Classification
Reporting Instruction Overview
- Contact Dates
  - Determining Contact Dates
  - Subsequent Infusions and Contact Dates
- GVHD
- Lines of Therapy

Instructions for Gene Therapy Product Form (Form 2003)

This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Gene Therapy Product Form.

Last modified: Nov 01, 2021

Q21-45: Persistence of Cells

2003: Gene Therapy Product

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