Double Cord Blood Transplantation
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Neuroblastoma; Immunodeficiencies; Anemia
Intervention: 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, (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Columbia University Official(s) and/or principal investigator(s): Prakash Satwani, MD, Principal Investigator, Affiliation: Columbia University
Summary
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.
Clinical Details
Official title: Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant.
Secondary outcome: To quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant and non-malignant disorders.
Eligibility
Minimum age: N/A.
Maximum age: 30 Years.
Gender(s): Both.
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
Locations and Contacts
Columbia Presbyterian Medical Center, New York, New York 10032, United States
Additional Information
Starting date: September 2007
Last updated: July 17, 2013
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