Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

ClinicalTrials.gov ID: NCT01529827

Public ClinicalTrials.gov record NCT01529827. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening

Study identification

NCT ID: NCT01529827
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Roswell Park Cancer Institute; Other
Enrollment: 94 participants

Conditions and interventions

Conditions

Interventions

fludarabine phosphate Drug
melphalan Drug
total-body irradiation Radiation
tacrolimus Drug
mycophenolate mofetil Drug
methotrexate Drug
laboratory biomarker analysis Other
allogeneic hematopoietic stem cell transplantation Procedure
peripheral blood stem cell transplantation Procedure

Drug · Radiation · Other + 1 more

Eligibility (public fields only)

Age range: 3 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 27, 2012
Primary completion: May 27, 2015
Completion: Aug 28, 2019
Last update posted: Sep 23, 2019

2012 – 2019

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Roswell Park Cancer Institute	Buffalo	New York	14263	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01529827, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 23, 2019 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01529827 live on ClinicalTrials.gov.

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