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Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

NCT01188798•St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine if participants who receive the GVHD prophylaxis medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin recipients.

Detailed Description

Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor. All participants will receive a standard backbone GVHD prophylaxis regimen (tacrolimus and sirolimus) and conditioning (cyclophosphamide/TBI). A risk-adapted approach will be used during conditioning to further minimize the risk of leukemia relapse based on two factors: 1. Lymphoid versus myeloid primary disease. 2. KIR compatibility between donor and host.

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\*Age less than or equal to 21 years old
•High risk malignancy as follows:
•High-risk ALL in CR1. Examples include, but not limited to: Induction failure or \> 1% leukemic lymphoblasts in the bone marrow on remission date;\> 0.1% leukemic lymphoblasts in the bone marrow in week 7 of continuation treatment (i.e. before reinduction I); re-emergence of leukemic lymphoblasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels;early T-cell precursor (ETP) ALL.
•High-risk ALL beyond CR1, or with refractory disease. "Beyond CR1" denotes any CR following CR1, or any relapsed state. "Refractory disease" includes induction failure.
•High-risk de novo AML in CR1.Examples include but are not limited to:evidence of a high-risk genetic abnormality or high-risk MRD features.
•AML beyond CR1, or with refractory disease. "Beyond CR1" denotes any CR following CR1, or any relapsed state. "Refractory disease" includes induction failure.
•Therapy-related AML.
•MDS, primary or secondary, at any stage.
•NK cell lymphoblastic leukemia in any CR
•Biphenotypic bilineage, or undifferentiated leukemia.
+16 more criteria

Exclusion Criteria

•Pregnant and lactating females are excluded from participation as the short and long-term effects of the protocol interventions and infusion on a fetus or a nursing child through breast milk are not entirely known at this time.

Locations (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

March 21, 2013

Enrollment

ACTUAL participants

Conditions

Acute Lymphoblastic LeukemiaAcute Myelocytic LeukemiaChronic Myelocytic LeukemiaHodgkin's DiseaseMyelodysplastic Syndrome

Interventions

Methotrexate

DRUG

Pentostatin

DRUG

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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 21, 2013Data 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

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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