CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
anti-thymocyte globulin +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/NCT00425802
NCT00425802Phase 2Completed

A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 23, 2007·Updated Oct 31, 2017

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, filgrastim, and 8 other interventions for Leukemia and Lymphoma. Completed, enrolled 61 participants across 1 site.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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 rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2007
Enrollment StartNov 28, 2006
Primary CompletionOct 28, 2016
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 19.4 years ago

Interventions

anti-thymocyte globulinbiological

filgrastimbiological

graft-versus-tumor induction therapybiological

rituximabbiological

cyclophosphamidedrug

cyclosporinedrug

fludarabine phosphatedrug

mycophenolate mofetildrug

nonmyeloablative allogeneic hematopoietic stem cell transplantationprocedure

total-body irradiationradiation