Double Cord Blood Transplantation

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00801931
First received: May 5, 2008
Last updated: July 17, 2013
Last verified: July 2013
  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
Immunodeficiencies
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:


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 ]

Enrollment: 1
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (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:
  • Thiotepa
  • Cytoxan
  • ATG
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:
  • ATG
  • Busulfex
  • Alkeran
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:
  • Fludara
  • Busulfex
  • Campath
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:
  • Busulfex
  • Fludara
  • ATG
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:
  • Fludara
  • Cytoxan
  • ATG
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:
  • Busulfex
  • Cytoxan
  • ATG

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Cord Blood Transplant
Allogeneic Stem Cell Transplant

Additional relevant MeSH terms:
Neuroblastoma
Immunologic Deficiency Syndromes
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Immune System Diseases
Cyclophosphamide
Fludarabine phosphate
Melphalan
Busulfan
Thiotepa
Fludarabine
Alemtuzumab
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014