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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

Page last updated: August 23, 2015

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