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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01096992
First received: March 30, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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:


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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Bendamustine Combined with Fixed-Dose Fludarabine and Rituximab (FBR) [ Time Frame: After 4 week cycle ] [ Designated as safety issue: Yes ]
    MTD defined as highest dose level in which 6 participants have been treated with </= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.


Secondary Outcome Measures:
  • Response Rate of Bendamustine Combined with Fixed-Dose Fludarabine and Rituximab (FBR) [ Time Frame: 2 months after 6th cycle ] [ Designated as safety issue: No ]
    Complete, partial, and overall response rate estimated with 95% confidence interval. Associations between prognostic factors and response and time-to-event endpoints evaluated. Efficacy endpoints for evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Complete, nodular partial and partial response rates evaluated.


Estimated Enrollment: 82
Study Start Date: April 2010
Estimated Primary Completion Date: April 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096992

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01096992     History of Changes
Other Study ID Numbers: 2009-0546, NCI-2011-01942
Study First Received: March 30, 2010
Last Updated: August 8, 2014
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
Nitrogen Mustard Compounds
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014