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PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation | Clinical Trials | Clareo Health

TERMINATEDPHASE3

PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation

PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant

NCT01366612•Hackensack Meridian Health

View on ClinicalTrials.gov

Summary

This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity. The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.

Detailed Description

This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity. The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (myelogenous leukemia, chronic myelogenous leukemia, other myeloproliferative disorder, or myelodysplastic syndrome) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI. Primary Objective The primary objective is to compare the relapse rate at 1 year of patients with myeloid malignancies receiving each regimen. Secondary Objectives The secondary objective is to compare the toxicity of each regimen

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of acute myelogenous leukemia, chronic myelogenous leukemia, other myeloproliferative disorder, or myelodysplastic syndrome
•Any stage of disease will be considered for transplantation
•Have a suitable related or unrelated donor (Section 3.3)
•Age ≥18 but \<70 yrs
•KPS of ≥70%
•Recovery from all hematologic and non-hematology toxicities from previous therapies.
•HLA 6/6 (HLA-A, B, DrB1) related donor or 7/8 (HLA-A, B, C, DrB1) unrelated donor Related donors will be evaluated in accordance with HUMC standard practice guidelines for the evaluation and management of allogeneic donors Unrelated donors will be identified, evaluated, and managed in accordance with National Marrow Donor Program standards Age ≥18 and \<70 yrs KPS of ≥70% Willing to donate bone marrow using standard techniques or peripheral blood HSC by leukapheresis Have adequate veins for apheresis or agree to placement of a central venous catheter (femoral, subclavian) if donating peripheral blood HSC

Exclusion Criteria

•Diagnosis other than acute myelogenous leukemia, myeloproliferative disorder, or myelodysplastic syndrome
•Chemotherapy or radiotherapy within 14 days of initiating treatment in this study with the exception of lenalidomide, decitabine, azacitidine, imatinib mesylate, dasatinib, nilotinib hydrochloride and hydroxyurea
•Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
•Uncontrolled bacterial, viral, fungal or parasitic infections
•Uncontrolled CNS metastases
•Known amyloid deposition in heart
•Organ dysfunction
•* LVEF \<40% or cardiac failure not responsive to therapy
•* FVC, FEV1, or DLCO \<50% of predicted and/or receiving supplementary continuous oxygen
•* Evidence of hepatic synthetic dysfunction, or total bilirubin \>2x or AST \>3x ULN
+10 more criteria

Locations (1)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

June 16, 2010

Primary Completion Date

August 17, 2020

Completion Date

August 18, 2020

Last Updated

March 9, 2026

Enrollment

ACTUAL participants

Conditions

Myeloid MalignanciesAcute Myelogenous LeukemiaChronic Myelogenous LeukemiaMyeloproliferative DisordersMyelodysplastic Syndrome

Interventions

Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)

DRUG

Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)

DRUG

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AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 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 9, 2026Data 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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PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation

Inclusion Criteria

Exclusion Criteria

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

Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

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