Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant
Fludarabine, Bendamustine, and Rituximab (FBR) Non-Myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies
Sponsor: M.D. Anderson Cancer Center
This PHASE1 trial investigates CD20 Positive and Chronic Lymphocytic Leukemia and is currently completed. M.D. Anderson Cancer Center leads this study, which shows 9 recorded versions since 2009 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. To determine engraftment and dose limiting toxicity (DLT) of bendamustine in patients with lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.
SECONDARY OBJECTIVES:
I. To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.
OUTLINE: This is a dose escalation study of bendamustine.
Participants receive rituximab intravenously (IV) over 5-7 hours on days -13 and -6, fludarabine IV over 1 hour and bendamustine IV over 1 hour on days -5 to -3, and tacrolimus IV starting on day -2 and orally (PO) after hospital discharge for 6 to 8 months. Participants with matched unrelated donor (MUD) receive thymoglobulin on days -2 and -1. Participants undergo allogenic stem cell transplant over 30-45 minutes on day 0. Participants receive rituximab IV over 5-7 hours on days 1 and 8 and methotrexate IV over 30 minutes on days 1, 3, and 6. Participants with MUD also receive methotrexate IV on day 11. Participants receive filgrastim (G-CSF) subcutaneously (SC) once daily starting on day 7 until white blood cell counts recover.
After completion of study treatment, participants are followed up every 3 months during year 1 and every 6 months for up to 3 years.
PRIMARY OBJECTIVES:
I. To determine engraftment and dose limiting toxicity (DLT) of bendamustine in patients with lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.
SECONDARY OBJECTIVES:
I. To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.
OUTLINE: This is a dose escalation study of bendamustine.
Participants receive rituximab intravenously (IV) over 5-7 hours on days -13 and -6, fludarabine IV over 1 hour and bendamustine IV over 1 hour on days -5 to -3, and tacrolimus IV starting on day -2 and orally (PO) after hospital discharge for 6 to 8 months. Participants with matched unrelated donor (MUD) receive thymoglobulin on days -2 and -1. Participants undergo allogenic stem cell transplant over 30-45 minutes on day 0. Participants receive rituximab IV over 5-7 hours on days 1 and 8 and methotrexate IV over 30 minutes on days 1, 3, and 6. Participants with MUD also receive methotrexate IV on day 11. Participants receive filgrastim (G-CSF) subcutaneously (SC) once daily starting on day 7 until white blood cell counts recover.
After completion of study treatment, participants are followed up every 3 months during year 1 and every 6 months for up to 3 years.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jul 2019 — Jan 2021 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
▶ Show 4 earlier versions
-
Oct 2018 — Jul 2019 [monthly]
Active Not Recruiting PHASE1
-
Jun 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE1
-
Aug 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE1
Status: Completed → Active Not Recruiting
-
Jan 2017 — Aug 2017 [monthly]
Completed PHASE1
First recorded
Feb 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .