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NCT01177371 · ClinicalTrials.gov registry record · Phase 2

High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma

A Phase 2 study, sponsored by Case Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT01177371: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.

NCT01177371 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01177371, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a 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 cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from happening. PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.

Primary Outcome

no evidence of leukemia as judged by two peripheral blood smears and two bone marrow aspirates and biopsies. Disease-free and overall survival data will be computed from the day of marrow infusion.

Interventions

  • DRUG cyclophosphamide
  • DRUG methylprednisolone
  • DRUG methotrexate
  • DRUG busulfan
  • PROCEDURE allogeneic bone marrow transplantation

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 1988-03
Est. Completion 2010-02
Phase Phase 2
Case Comprehensive Cancer Center

407 total trials

What the finished NCT01177371 record still lists

NCT01177371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

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

NCT01177371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01177371 about?

NCT01177371 is a clinical study titled "High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma". RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are inf...

What is the current status of trial NCT01177371?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 1988-03. Estimated completion is 2010-02.

What interventions are being tested in trial NCT01177371?

The interventions under investigation include: cyclophosphamide (DRUG), methylprednisolone (DRUG), methotrexate (DRUG), busulfan (DRUG), allogeneic bone marrow transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01177371?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01177371's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 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 NCT01177371, the US trial registry maintained by the National Library of Medicine. NCT01177371 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.