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NCT01529827 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 2
Development phase
94
Enrollment target

NCT01529827: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT01529827 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01529827, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
94 participants
Enrollment target

Study Summary

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

Primary Outcome

Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.

Interventions

  • DRUG fludarabine phosphate
  • DRUG tacrolimus
  • DRUG melphalan
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2012-02-28
Est. Completion 2019-08-29
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What the finished NCT01529827 record still lists

NCT01529827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT01529827 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01529827 about?

NCT01529827 is a clinical study titled "Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies". 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 an...

What is the current status of trial NCT01529827?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2012-02-28. Estimated completion is 2019-08-29.

What interventions are being tested in trial NCT01529827?

The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), melphalan (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT01529827?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01529827's enrollment target sits among peer trials

94 764th of 2000 higher than 1,235 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01529827, the US trial registry maintained by the National Library of Medicine. NCT01529827 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.