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Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor | Clinical Trials | Clareo Health

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Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor

NCT01598025•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

Approximately 30% of patients who are candidates for bone marrow transplants do not have an HLA-matched, or close to matched, donor available. For this reason, doctors have been testing ways to make transplants from HLA-partially matched donors as safe and effective as transplants from HLA-matched donors. This study is being done to test the safety and the treatment results of a specific kind of transplant. In this transplant, blood from two donors will be used. Each donor will share one half of your HLA type. Blood from both donors will be transplanted at the same time.

Eligibility

Age

0 - 19 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Malignant conditions for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:
•AML in 1st remission - for patients whose AML does not have 'good risk' cytogenetic features (i.e. t 8;21, t15;17, inv 16).
•Secondary AML in 1st remission
•AML in 1st relapse or \> 2nd remission
•ALL/LL in 1st remission clinical or molecular features indicating a high risk for relapse; or ALL \> 2nd remission
•CML failing to respond to or not tolerating Imatinib, dasatinib, or nilotinib in first chronic phase of disease; or CML in accelerated phase or second chronic phase.
•Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories: a) intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
•Each donor must meet criteria outlined by institutional policies
•Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.

Exclusion Criteria

•Chronic myelomonocytic leukemia: CMML-1 and CMML-2.
•Other rare lethal disorders of Hematopoiesis and Lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or conjugated cytopenias; non-SCID lethal genetic immunodeficiencies such as Wiskott Aldrich Syndrome, CD40 ligand deficiency, ALPS).
•Patients may be of either gender and of any racial or ethnic background.
•Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%.
•Patients must have adequate organ function measured by:
•Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50% and must improve with exercise.
•Hepatic: \< 3x ULN ALT and \< 2.0x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
•Renal: serum creatinine \<1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated)
•Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
•Each patient must be willing to participate as a research subject and must sign an informed consent form.
+6 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

May 2, 2012

Primary Completion Date

October 16, 2017

Completion Date

October 16, 2017

Last Updated

August 9, 2018

Enrollment

ACTUAL participants

Conditions

Acute LeukemiaChronic LeukemiaMyelodysplastic SyndromeNon-Hodgkins Lymphoma

Interventions

total-body irradiation (TBI)

RADIATION

thiotepa

DRUG

fludarabine phosphate

DRUG

melphalan

DRUG

anti-thymocyte globulin

BIOLOGICAL

allogeneic hematopoietic stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

BIOLOGICAL

laboratory biomarker analysis

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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: August 9, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor

Inclusion Criteria

Exclusion Criteria

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