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TERMINATEDPHASE2

Unrelated Donor Transplant for Malignant and Non-Malignant Disorders

Unrelated Donor Stem Cell Transplant for Patients With Malignant and Non-Malignant Disorders

NCT01050439•Columbia University

Summary

Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell transplantation (UDAlloSCT) with either myeloablative 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.

Detailed Description

This is a non-randomized study to determine the tolerability and degree of engraftment of unrelated matched donor allogeneic stem cell transplantation with either myeloablative or reduced intensity conditioning in patients with selected malignant and non malignant disorders. Patients will receive one of either full intensity or reduced intensity regimen based on the patient's disease status, organ function and performance and determined by the PI.

Eligibility

Age

0 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 of \> 40% by radionuclide angiogram or echocardiogram.
•Adequate pulmonary function defined as: 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% in room air.
•Diseases:
•* CML (CP, AP or BC)
•* AML/MDS/JCML
•* ALL
•* Lymphoma (Hodgkin's and non-Hodgkin's)
•* Non-malignant disorders
+27 more criteria

Exclusion Criteria

•Women who are pregnant and/or breast feeding are ineligible

Locations (1)

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

November 1, 2002

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

April 15, 2015

Enrollment

ACTUAL participants

Conditions

LeukemiaLymphomaBone Marrow Failure SyndromesImmunodeficienciesHistiocytosis

Interventions

UDAlloSCT

PROCEDURE

Therapy

OTHER

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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: April 15, 2015Data 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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Unrelated Donor Transplant for Malignant and Non-Malignant Disorders

Inclusion Criteria

Exclusion Criteria

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

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)

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