S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

NCT00939328 | Withdrawn Phase 2 DMC

• 2 other identifiers: S0902U10CA032102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

• Response rate (CR, CRi, or PR)

• Safety and tolerability

Interventions

rituximab BIOLOGICAL

bendamustine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) * Progressive or symptomatic disease * Purine analog-refractory disease * Must meet 1 of the following criteria: * Intermediate- or high-risk modified-Rai stage * Low-risk modified-Rai stage and progressive lymphocytosis, defined as \> 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months * Received 1 or more prior therapies for CLL * Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients" PATIENT CHARACTERISTICS: * Zubrod performance status 0-3 * ANC \> 1,000/mm³ * Platelet count \> 50,000/mm³ * Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years * HIV positivity allowed provided the following criteria are met: * CD4 cells \> 350/mm³ * No concurrent antiretroviral therapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 28 days since prior chemotherapy, any other investigational agents, or major surgery * More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation * If prior allogeneic bone marrow transplantation, must meet the following criteria: * Performed \> 120 days ago * No acute graft-vs-host disease (GVHD) ≥ grade 2 * Receiving no immunosuppressive therapy for chronic GVHD * No concurrent antiretroviral therapy for HIV-positive patients * No concurrent CYP1A2 inhibitors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Bendamustine Hydrochloride

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)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

Study Officials

• Matt E. Kalaycio, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 6, 2015

Record last verified: 2015-03