deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00880815

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

Updated 9 times since 2017 Last updated: May 30, 2019 Started: Feb 17, 2009 Primary completion: May 28, 2019 Completion: May 28, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotCompleted~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshotActive Not Recruiting~Oct 2018 – ~Jul 2019 · 9 months · monthly snapshotActive Not Recruiting~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jul 2019 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Oct 2018 — Jul 2019 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE1

  3. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: CompletedActive Not Recruiting

  4. 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

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations