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TERMINATEDPHASE1/PHASE2

Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders

Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders

NCT00801931•Columbia University

Summary

The purpose of this study is to determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant, and to quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant and non-malignant disorders.

Detailed Description

Allogeneic stem cell transplantation from an human leukocyte antigen (HLA) matched related family donor is the treatment of choice for a wide variety of malignant and non-malignant disorders. Unfortunately, only 25% of potential recipients have an HLA matched related family donor, leaving approximately 75% of potential recipients requiring alternative sources of HLA matched allogeneic stem cells. One potential source of HLA matched allogeneic stem cells is from unrelated adult donors that have been identified in the national and international donor registries. However, several limitations restrict the uniform utilization of unrelated allogeneic adult donors including ethnic background of the recipient, acuity and timing of planned allogeneic transplant, availability of donor, and high risk of severe acute graft-versus-host disease (GVHD) (III/IV), among others. The investigators have recently identified a new alternative source of allogeneic stem cells, unrelated cryopreserved placental/cord blood stem cells.

Eligibility

Age

0 - 30 years

Sex

ALL

Healthy Volunteers

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 glomerular filtration rate (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 serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase (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 diffusing capacity of the lungs for carbon monoxide (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 (1)

Columbia Presbyterian Medical Center

New York, New York, United States

Key Dates

Start Date

September 6, 2007

Primary Completion Date

May 5, 2009

Completion Date

May 5, 2009

Last Updated

March 27, 2019

Enrollment

ACTUAL participants

Conditions

LeukemiaLymphomaNeuroblastomaImmunodeficienciesAnemia

Interventions

Alemtuzumab

DRUG

Total Body Irradiation

RADIATION

Melphalan

DRUG

Busulfan

DRUG

Phenytoin

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Horse Antithymocyte Globulin

DRUG

Rabbit Antithymocyte Globulin

DRUG

Thiotepa

DRUG

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NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients