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Busulfan and Cyclophosphamide Followed By ALLO BMT | Clinical Trials | Clareo Health

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Busulfan and Cyclophosphamide Followed By ALLO BMT

Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies

NCT01685411•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

Detailed Description

This is a single arm trial to evaluate the efficacy of busulfan and cyclophosphamide followed by an allogeneic hematopoietic stem cell transplant (HSCT) in the treatment of hematological malignancies. The intent of this study is to provide a protocol that will use unmanipulated allogeneic hematopoietic stem cells from related and unrelated donors after a common preparative regimen.

Eligibility

Age

0 - 44 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following:
•* \<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT)
•* \<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
•Karnofsky performance status \>70% or if \<16 years of age, a Lansky play score \>50
•Adequate major organ function including:
•* cardiac: left ventricular ejection fraction \>45% by echocardiogram (ECHO/MUGA)
•* renal: creatinine clearance \>40 mL/min/1.73m\^2
•* hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)
•An acceptable source of stem cells according to current University of Minnesota Bone Marrow Transplant program guidelines. Acceptable stem cell sources include:
•* HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)
+4 more criteria

Exclusion Criteria

•eligible for TBI containing preparative regimen
•active uncontrolled infection within one week of study enrollment
•pregnant or lactating female

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

February 10, 2020

Completion Date

February 10, 2020

Last Updated

April 13, 2021

Enrollment

ACTUAL participants

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome

Interventions

Allopurinol

DRUG

Keppra

DRUG

Busulfan

DRUG

Cyclophosphamide

DRUG

Tacrolimus

DRUG

Mycophenolate mofetil

DRUG

Allogeneic hematopoietic stem cell transplant

BIOLOGICAL

Filgrastim

BIOLOGICAL

antithymocyte globulin

BIOLOGICAL

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

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

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

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RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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 13, 2021Data 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

Busulfan and Cyclophosphamide Followed By ALLO BMT

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation