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NCT01093586 · ClinicalTrials.gov registry record · Phase 2

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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

Completed
Registry status
Phase 2
Development phase
14
Enrollment target

NCT01093586: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.

NCT01093586 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01093586, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study Summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) 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 stem cells from an unrelated donor, that do not exactly match the patient's blood, 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.

Primary Outcome

Number of participants alive at 180 days post engraftment.

Interventions

  • DRUG busulfan
  • PROCEDURE bone marrow aspiration
  • OTHER cytogenetic analysis
  • PROCEDURE double-unit umbilical cord blood transplantation
  • OTHER fluorescence in situ hybridization

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-09
Est. Completion 2015-12
Phase Phase 2
Case Comprehensive Cancer Center

407 total trials

What the finished NCT01093586 record still lists

NCT01093586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

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

NCT01093586 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01093586 about?

NCT01093586 is a clinical study titled "Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies". RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) 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 stem cells from an unrelated donor, that do not exactly match the patient...

What is the current status of trial NCT01093586?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2007-09. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01093586?

The interventions under investigation include: busulfan (DRUG), bone marrow aspiration (PROCEDURE), cytogenetic analysis (OTHER), double-unit umbilical cord blood transplantation (PROCEDURE), fluorescence in situ hybridization (OTHER).

Who is sponsoring clinical trial NCT01093586?

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 NCT01093586's enrollment target sits among peer trials

14 1941st of 2000 higher than 54 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 NCT01093586, the US trial registry maintained by the National Library of Medicine. NCT01093586 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.