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

NCT01096992 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2009-0546NCI-2011-01942
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Chronic lymphocytic leukemia; CLL; Bendamustine; Fludarabine; Fludara; Fludarabine Phosphate; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)

  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.

  After 4 week cycle

Secondary Outcomes (1)

• Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)

  Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.

Study Arms (5)

Phase 1 20 mg/m^2

EXPERIMENTAL

Bendamustine, Fludarabine + Rituximab

Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

Phase 2

EXPERIMENTAL

Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab

Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

Phase 1 30 mg/m^2

EXPERIMENTAL

Bendamustine, Fludarabine + Rituximab

Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

Phase 1 40 mg/m^2

EXPERIMENTAL

Bendamustine, Fludarabine + Rituximab

Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

Phase 1 50 mg/m^2

EXPERIMENTAL

Bendamustine, Fludarabine + Rituximab

Drug: Bendamustine; Drug: Fludarabine; Drug: Rituximab

Interventions

Bendamustine DRUG

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)

Also known as: Bendamustine HCI, Bendamustine Hydrochloride, CEP-18083, SDX-105, Treanda

Phase 1 20 mg/m^2; Phase 1 30 mg/m^2; Phase 1 40 mg/m^2; Phase 1 50 mg/m^2; Phase 2

Fludarabine DRUG

Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3

Also known as: Fludara, Fludarabine Phosphate

Phase 1 20 mg/m^2; Phase 1 30 mg/m^2; Phase 1 40 mg/m^2; Phase 1 50 mg/m^2; Phase 2

Rituximab DRUG

Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1

Also known as: Rituxan

Phase 1 20 mg/m^2; Phase 1 30 mg/m^2; Phase 1 40 mg/m^2; Phase 1 50 mg/m^2; Phase 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated
• Patients must have an indication for treatment by 2008 IWCLL Criteria
• Age \>/= 16 years
• Zubrod performance status \</= 2
• 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
• Patients must give written informed consent
• Patients of childbearing potential must be willing to practice birth control during the study

You may not qualify if:

• Pregnant or breast-feeding females
• Significant co-morbidity indicated by major organ system dysfunction
• Active, uncontrolled infection, including active hepatitis
• Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; fludarabine; fludarabine phosphate; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: William Wierda, MD./Professor
• Organization: The University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-745-0428

Study Officials

• William G. Wierda, MD, PhD, BS

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: April 19, 2010
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Locations

US (1)