CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
filgrastim +8 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/NCT00387959
NCT00387959Phase 2Completed

A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies

Memorial Sloan Kettering Cancer Center·interventional·Posted Oct 13, 2006·Updated Feb 1, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, rituximab, and 7 other interventions for Leukemia and Lymphoma. Completed, enrolled 17 participants across 1 site.

Detailed Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2006
Enrollment StartJul 1, 2006
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 19.7 years ago

Interventions

filgrastimbiological

rituximabbiological

cyclophosphamidedrug

cyclosporinedrug

fludarabine phosphatedrug

mycophenolate mofetildrug

allogeneic hematopoietic stem cell transplantationprocedure

umbilical cord blood transplantationprocedure

total-body irradiationradiation