CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
rituximab +7 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/NCT01027000
NCT01027000Phase 2Completed

Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL)

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 7, 2009·Updated May 6, 2023

In Brief

A Phase 2 clinical trial evaluating rituximab, busulfan, and 6 other interventions for Leukemia and Lymphoma. Completed, enrolled 68 participants across 25 sites.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy before a donor 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. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 7, 2009
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2016
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.6 years ago

Interventions

rituximabbiological

busulfandrug

cyclophosphamidedrug

fludarabine phosphatedrug

methotrexatedrug

sirolimusdrug

tacrolimusdrug

allogeneic stem cell transplantprocedure