Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00891839
First received: April 29, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: Bendamustine
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Bendamustine Hydrochloride in Combination With Rituximab in the Treatment of Patients With Relapsed/Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: End of cycles 3 and 6 (each cycle = 28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: Date of the first response to date of progression or death ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: First administration of study drug to the date of progression or death ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Date of the first administration of study drug to date of death ] [ Designated as safety issue: No ]
  • Safety and tolerability of bendamustine in combination with rituximab [ Time Frame: Periodically, during 6-8 cycles (6-8 months treatment duration) ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: June 2009
Study Completion Date: May 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine+Rituximab
Patients receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles are planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
Drug: Bendamustine
Bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
Other Names:
  • bendamustine HCl
  • TREANDA®
  • CEP-18083
Drug: Rituximab
Patients receive 375 mg/m^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
Other Name: Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histopathologically confirmed diagnosis of typical or atypical mantle cell lymphoma, except for blastoid type.
  • documented relapsed/refractory mantle cell lymphoma.
  • CD20 positive B cells in the lymph node biopsy or other lymphoma pathology specimen.
  • adequate hematologic function according to specific trial parameters.
  • bidimensionally measurable disease with at least 1 lesion measuring 2.0 cm or more in a single dimension, or the patient is in the leukemic phase of the disease.
  • patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • patient has an estimated life expectancy of at least 3 months.
  • women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
  • men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of study drug treatment and for 30 days after participation in the treatment period.

Exclusion Criteria:

  • has received more than 3 previous standard chemotherapy regimens.
  • has the blastoid subtype of mantle cell lymphoma.
  • documented history of central nervous system (CNS) lymphomatous involvement.
  • a history of previous high-dose chemotherapy with allogeneic stem cell transplantation (history of autologous stem cell transplantation is allowed).
  • previous treatment with bendamustine.
  • has an active malignancy other than MCL, or has had a malignancy other than MCL within the past 3 years, except for controlled prostate cancer without evidence of bone metastases, localized bladder cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer.
  • has New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
  • has serum creatinine of more than 2.0 mg/dL or creatinine clearance of less than 30 mL/min based on the Cockcroft-Gault method or from a 24-hour urine collection.
  • does not have adequate hepatic organ function as evidenced by specific trial parameters.
  • has known human immunodeficiency virus (HIV) infection.
  • has active hepatitis B infection. Hepatitis B surface antigen must be tested.
  • a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • has received corticosteroids within 28 days of study entry unless chronically administered (prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications.
  • any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to participate in or complete this study.
  • any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
  • patient has received other investigational agent(s) within 28 days of study entry.
  • patient has received chemotherapy within the prior 28 days.
  • patient has a known hypersensitivity to bendamustine, mannitol, or rituximab.
  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: NCT00891839

Locations
United States, California
Teva Investigational Site 11
Fountain Valley, California, United States
Teva Investigational Site 2
Los Angeles, California, United States
United States, Florida
Teva Investigational Site 35
Orlando, Florida, United States
United States, Indiana
Teva Investigational Site 30
Lafayette, Indiana, United States
United States, Maryland
Teva Investigational Site 20
Bethesda, Maryland, United States
United States, New Jersey
Teva Investigational Site 4
Hackensack, New Jersey, United States
United States, New York
Teva Investigational Site 3
Buffalo, New York, United States
United States, Pennsylvania
Teva Investigational Site 43
Gettysburg, Pennsylvania, United States
United States, Texas
Teva Investigational Site 33
Bryan, Texas, United States
Teva Investigational Site 41
Grapevine, Texas, United States
United States, Virginia
Teva Investigational Site 23
Lynchburg, Virginia, United States
Canada
Teva Investigational Site 6
Ottawa, Canada
Teva Investigational Site 7
Toronto, Canada
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00891839     History of Changes
Other Study ID Numbers: C18083/2039/NL/US-CA
Study First Received: April 29, 2009
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014