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

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ClinicalTrials.gov Identifier: NCT01096992
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Drug: Bendamustine Drug: Fludarabine Drug: Rituximab Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : April 19, 2010
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Bendamustine Combined with Fixed-Dose Fludarabine and Rituximab (FBR) [ Time Frame: After 4 week cycle ]
    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 :
  1. Overall Response Rate of Bendamustine Combined with Fixed-Dose Fludarabine and Rituximab (FBR) [ Time Frame: Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment. ]
    Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01096992     History of Changes
Other Study ID Numbers: 2009-0546
NCI-2011-01942 ( Registry Identifier: NCI CTRP )
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Fludarabine phosphate
Rituximab
Bendamustine Hydrochloride
Vidarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents