Randomized Double Cord Blood Transplant Study
Randomized Trial of Unmanipulated Versus Expanded Cord Blood
3 other identifiers
interventional
110
1 country
1
Brief Summary
The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 8, 2003
CompletedFirst Posted
Study publicly available on registry
August 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
May 1, 2019
CompletedMay 1, 2019
April 1, 2019
13.3 years
August 8, 2003
July 31, 2017
April 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time To Neutrophil Engraftment
Engraftment is defined as a sustained ANC \> 0.5 x 10\^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) \>/= 0.5 x 10\^9/L.
First 100 days, evaluation and blood tests twice weekly
Number of Participants With Engraftment
Engraftment defined as a sustained absolute neutrophil count (ANC) \> 0.5 x 10\^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC \<500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination.
First 100 days, evaluation and blood tests twice weekly
Secondary Outcomes (3)
Rate of Acute Graft Versus Host Disease (GVHD)
Review over first 100 days
Rate of Chronic GVHD
Up to one year
Number of Participants Severity of Acute GVHD by Treatment Arm
Following first 100 days, up to one year
Study Arms (2)
Double Cord Blood Transplant Group
EXPERIMENTALTwo Unmanipulated Cord Blood units. Rituxan 375 mg/m2 by vein for patients with CD20 + malignancies. Melphalan 140 mg/m2 by vein on Day -8. Thiotepa 5 mg/Kg by vein on Day -7. Fludarabine 40 mg/m2 by vein on Days -6 to -3.
One Expanded Cord Blood Transplant Group
EXPERIMENTALOne Unmanipulated and One Expanded Cord Blood Unit. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Cyclophosphamide 50 mg/kg by vein on Day -6. Mesna 10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). Total body irradiation (TBI) given on Day -1 at 2 Gy.
Interventions
Transplantation of Two Unmanipulated Cord Blood Units.
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
40 mg/m2 by vein on Days -6 to -3.
50 mg/kg by vein on Day -6.
10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
Total body irradiation (TBI) given on Day -1 at 2 Gy.
Eligibility Criteria
You may qualify if:
- Disease-Specific Eligibility Requirements: Patients must have one of the following hematologic malignancies: 1. Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) 2. Acute Lymphoblastic Leukemia (ALL) 3. Chronic Myelogenous Leukemia (CML) 4. Non-Hodgkin's Lymphoma (NHL) 5. Hodgkin's Disease (HD) 6. Chronic Lymphocytic Leukemia (CLL) 7. Chronic eosinophilic leukemia or Philadelphia chromosome negative CML.
- Greater than 1 month old and \<=60 years old for full myeloablative therapy.
- Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each cord must contain at least 1E7 total nucleated cells/Kg recipient body weight in the pre-thawed fraction.
- Patient must be willing to undergo bone marrow harvest or peripheral blood progenitor cell (PBPC) collection for use in case of engraftment failure. If the patient is unable or fails to successfully undergo the collection, a family member must be identified to donate hematopoietic stem cells for haploidentical transplant in case of engraftment failure. If autologous hematopoietic stem cells cannot be procured due to marrow contamination by malignancy, or due to harvest failure, and a haploidentical relative is not available or not willing to donate, two cord blood units can be used as the back-up graft.
- Continuation to Criteria # 4: These units will be identified prior to enrollment in this study.
- Regimen 1 (Myeloablative mel/thiotepa/fludarabine): 1.Patients with ALL, HD, NHL, AML, MDS, CML, CLL and Chronic eosinophilic leukemia who are candidates for full myeloablative therapy. 2.Performance score of at least 60% by Karnofsky (age \>= 12 years), or Lansky Play-Performance Scale (age \<12 years). 3.Age \>=1 month \<=60 years (high-dose).
- Continuation to Criteria # 6: 4.Adequate major organ system function as demonstrated by:a. Left ventricular ejection function of at least 40%. b.Pulmonary function test demonstrating a diffusion capacity of at least 50%. predicted (high-dose). c.Creatinine \< 1.6 mg/dL. d.serum glutamate pyruvate transaminase (SGPT)/bilirubin \<= to 2.0 x normal (high-dose).
- Eligibility for Regimen 2 (Non-myeloablative Cy-Flu-TBI): 1. Patients with ALL, AML, MDS, CML, NHL, CLL, Chronic eosinophilic leukemia and HD who are not candidates for full myeloablative therapy. All patients who received a prior autologous transplant are eligible. 2. Performance score of at least 60% by Karnofsky or PS \< 3 (ECOG) (age \>= 12 years), or Lansky Play-Performance Scale (age \<12 years) 3. Age \>= 1 month \<=80 years
- Continuation to Criteria # 8: 4. Left ventricular ejection function of at least 30%; 5. Pulmonary function test demonstrating a diffusion capacity of at least 40% predicted; 6. Creatinine \< 3.0 mg/dL; 7. SGPT \<= to 4.0 x normal.
- Regimen 3 (Myeloablative VP16-TBI): 1. Patients with ALL who are candidates for myeloablative therapy, and require a TBI-containing regimen. 2. Performance score of at least 60% by Karnofsky or PS \< 2 (ECOG) (age \>= 12 years), or Lansky Play-Performance Scale (age \<12 years). 3. Age \>= 1 month \<=50 years. 4. Organ function requirements: a. Left ventricular ejection function of at least 50%. b. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. c. Creatinine \< 1.6 mg/dL. d. SGPT \<= 2.0 x normal.
You may not qualify if:
- HIV positive.
- Pregnancy.
- Serious medical Condition.
- Patients with signs \& symptoms leading to positive lumbar puncture (malignant cells in the CSF) or to documented metastatic parenchymal disease are ineligible for this study.
- Availability of appropriate, willing, HLA-matched related donor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Cellgenixcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 770030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Simrit Parmar, MD/Associate Professor, Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Simrit Parmar, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2003
First Posted
August 11, 2003
Study Start
April 1, 2003
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
May 1, 2019
Results First Posted
May 1, 2019
Record last verified: 2019-04