drugset / Trial / NCT00880815

Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant

NCT00880815

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine, bendamustine, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes, the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving rituximab and methotrexate after the transplant may stop this from happening.

Timeline

Start
2009-02-17
Primary completion
2019-05-28
Completion
2019-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 Intravenous
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Bendamustine Small molecule 110 mg/m2 Intravenous
Subject Bendamustine Small molecule 130 mg/m2 Intravenous
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Background Fludarabine Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background Rituximab Monoclonal antibody Intravenous
Background Tacrolimus Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Intravenous