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Fludarabine, Bendamustine, and Rituximab (FBR) in Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01096992
First received: March 30, 2010
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before.

The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.


Condition Intervention Phase
Leukemia
 Drug: Bendamustine
Drug: Fludarabine
Drug: Rituximab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Dose Limiting Toxicity (DLT) + Maximum Tolerated Dose (MTD) [ Time Frame: 4 week cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: April 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1
Bendamustine, Fludarabine + Rituximab
 Drug: Bendamustine

Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)

Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Other Names:
  • Bendamustine HCI
  • Bendamustine Hydrochloride
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Fludarabine
Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Rituximab
Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1
Other Name: Rituxan
Experimental: Phase 2
Bendamustine 30 mg/m2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
 Drug: Bendamustine

Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)

Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Other Names:
  • Bendamustine HCI
  • Bendamustine Hydrochloride
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Fludarabine
Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Rituximab
Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1
Other Name: Rituxan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated
  2. Patients must have an indication for treatment by 2008 IWCLL Criteria
  3. Age >/= 16 years
  4. Zubrod performance status </= 2
  5. Adequate renal and hepatic function as indicated by all the following: a. serum creatinine </= 2 mg/dL AND; b. alanine aminotransferase (ALT) </= 2.5 times upper limit of normal AND; c. total bilirubin </= 2.5 times upper limit of normal
  6. Patients must give written informed consent
  7. Patients of childbearing potential must be willing to practice birth control during the study

Exclusion Criteria:

  1. Pregnant or breast-feeding females
  2. Significant co-morbidity indicated by major organ system dysfunction
  3. Active, uncontrolled infection, including active hepatitis
  4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
  5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (Prednisone >/ 60 mg daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096992

Contacts
Contact: William G. Wierda, MD, PhD, BS 713-745-0428

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: William G. Wierda, MD, PhD, BS            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: William G. Wierda, MD, PhD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01096992     History of Changes
Other Study ID Numbers: 2009-0546
Study First Received: March 30, 2010
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic lymphocytic leukemia
CLL
Bendamustine
Fludarabine
 Fludara
Fludarabine Phosphate
Rituximab
Rituxan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Fludarabine
Fludarabine monophosphate
Rituximab
Nitrogen Mustard Compounds
 Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013