Double Cord Blood Transplantation
This study has been terminated.
(Poor accrual)
Sponsor:
Columbia University
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00801931
First received: May 5, 2008
Last updated: January 19, 2011
Last verified: May 2009
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Purpose
Double umbilical cord blood transplantation (DUCBT) following high dose or reduced intensity conditioning will be well-tolerated and result in a high degree of engraftment in patients with selected malignant and non-malignant disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Neuroblastoma Immunologic Deficiency Syndrome Anemia |
Drug: TBI, Thiotepa, Cyclophosphamide, ATG Drug: Busulfan, Melphalan, Rabbit ATG Drug: Busulfan, Fludarabine, Alemtuzumab Drug: Busulfan, Fludarabine, Rabbit ATG Drug: Fludarabine, Cyclophosphamide, ATG Drug: Busulfan, Cyclosphosphamide, Rabbit ATG, |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Thiotepa
Busulfan
Melphalan
Melphalan hydrochloride
Fludarabine
Fludarabine phosphate
Alemtuzumab
U.S. FDA Resources
Further study details as provided by Columbia University:
Primary Outcome Measures:
- To determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant. [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant and non-malignant disorders. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: TBI, Thiotepa, Cyclophosphamide, ATG
APatients will start their pre-conditioning regimen on Day -8. Fractionated TBI will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5 and-4, Cyclophosphamide on Days -3 and -2 and- rabbit antithymocyte globulin on Days -4, -3, -2 and -1The double cord blood infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
| Experimental: B |
Drug: Busulfan, Melphalan, Rabbit ATG
Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with double cord blood infusion on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
| Experimental: C |
Drug: Busulfan, Fludarabine, Alemtuzumab
Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
| Experimental: D |
Drug: Busulfan, Fludarabine, Rabbit ATG
Patients will start their GVHD prophylaxis with Tacrolimus on Day -6. Patients will receive busulfan twice daily on Days -6, and-5; fludarabine on Days -6, -5, -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
| Experimental: E |
Drug: Fludarabine, Cyclophosphamide, ATG
Patients with Fanconi's Anemia will start their pre-conditioning regimen on Day -6. Patients will receive TBI as a single fraction on Day -6. Patients will receive fludarabine and cyclophosphamide on Days - 5, -4, -3, and -2 and anti-thymocyte globulin (horse) on Days -5, -4, -3, -2 and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
| Experimental: F |
Drug: Busulfan, Cyclosphosphamide, Rabbit ATG,
Patients with Selected Hemoglobinopathies and non-malignant diseaseswill begin fosphenytoin or phenytoin prophylaxis on Day -10. Patients will receive busulfan on days -9, -8, -7 and -6, cyclophosphamide on days -5, -4, -3, and -2 and rabbit antithymocyte globulin on days -4, -3, -2 and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Other Names:
|
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients will be eligible for double cord blood stem cell transplant (TNC ≥ 4x107/kg of two combined units) if available single cord blood has TNC ≤4.0 x 107/kg and they lack a matched (5-6/6) family donor, a 10/10 unrelated adult donor, and/or if their disease status required emergent stem cell transplant and they could not wait 2-3 months for searching for a matched unrelated adult donor.
- Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope GFR >60 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range.
- Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal
- Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction >47% by radionucleotide angiogram or echocardiogram.
- Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.
Eligibility for Moderate Intensity, Reduced Intensity Regimen and Fanconi's Anemia (Regimens C, D and E)
- Adequate renal function defined as: Serum creatinine <2.0 x normal, or Creatinine clearance or radioisotope GFR 40 ml/min/m2 or >40 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range.
- Adequate liver function defined as:Total bilirubin <2.5 x normal, or SGOT (AST) or SGPT (ALT) <5.0 x normal
- Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction >40% by radionucleotide angiogram or echocardiogram.
- Adequate pulmonary function defined as:Uncorrected DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.
Exclusion Criteria:
- Females who are pregnant or breast-feeding
- Patients with documented uncontrolled infection at the time of study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801931
Locations
| United States, New York | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
Columbia University
Investigators
| Principal Investigator: | Prakash Satwani, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Prakash Satwani, MD/ Principal Investigator, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00801931 History of Changes |
| Other Study ID Numbers: | AAAC3457, CHNY-06-533 |
| Study First Received: | May 5, 2008 |
| Last Updated: | January 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Cord Blood Transplant Allogeneic Stem Cell Transplant |
Additional relevant MeSH terms:
|
Anemia Immunologic Deficiency Syndromes Leukemia Lymphoma Neuroblastoma Hematologic Diseases Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Busulfan Cyclophosphamide Melphalan Thiotepa Fludarabine monophosphate Campath 1G Fludarabine Alemtuzumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013