CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
rituximab +9 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00691015
NCT00691015Phase 2Completed

A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation

Barbara Ann Karmanos Cancer Institute·interventional·Posted Jun 5, 2008·Updated Jun 28, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab, busulfan, and 8 other interventions for Chronic Myeloproliferative Disorders and 5 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 5, 2008
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.1 years ago

Interventions

rituximabbiological

Given IV

busulfandrug

Given IV

carmustinedrug

Given IV

cyclophosphamidedrug

Given IV

cytarabinedrug

Given IV

etoposidedrug

Given IV

fludarabine phosphatedrug

Given IV

melphalandrug

Given IV

total body irradiation (TBI)radiation

Given once or twice daily

anti-thymocyte globulin IVdrug

Given IV