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NCT00691015 · ClinicalTrials.gov registry record · Phase 2

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant

A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT00691015 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 48 participants.

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The verdict

NCT00691015, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL rituximab
  • DRUG carmustine
  • DRUG cytarabine
  • DRUG busulfan

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2008-05
Est. Completion 2014-04
Phase Phase 2

What the Registry Record Tells You About NCT00691015

The ClinicalTrials.gov registry entry for NCT00691015 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.

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

NCT00691015 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00691015 about?

NCT00691015 is a clinical study titled "Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant". RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace...

What is the current status of trial NCT00691015?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2008-05. Estimated completion is 2014-04.

What interventions are being tested in trial NCT00691015?

The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), carmustine (DRUG), cytarabine (DRUG), busulfan (DRUG).

Who is sponsoring clinical trial NCT00691015?

This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.