Clinical trial NCT00891839: Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma
Official title: An Open-Label Study of Bendamustine Hydrochloride in Combination With Rituximab in the Treatment of Patients With Relapsed/Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria
timeFrame: Month 3 (end of cycle 3), Month 6 (end of cycle 6)
Secondary outcomes:
measure: Kaplan-Meier Estimate for Duration of Response
timeFrame: Day 1 up to Month 43
measure: Kaplan-Meier Estimate for Progression-Free Survival
timeFrame: Day 1 up to Month 45
measure: Kaplan-Meier Estimate for Overall Survival
timeFrame: Day 1 up to Month 57
measure: Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)
timeFrame: Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)
measure: Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Day 0 (baseline) up to Month 8
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Teva Investigational Site 11
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 2
state: California
city: Orlando
country: United States
facility: Teva Investigational Site 35
state: Florida
city: Lafayette
country: United States
facility: Teva Investigational Site 30
state: Indiana
city: Bethesda
country: United States
facility: Teva Investigational Site 20
state: Maryland
city: Hackensack
country: United States
facility: Teva Investigational Site 4
state: New Jersey
city: Buffalo
country: United States
facility: Teva Investigational Site 3
state: New York
city: Gettysburg
country: United States
facility: Teva Investigational Site 43
state: Pennsylvania
city: Bryan
country: United States
facility: Teva Investigational Site 33
state: Texas
city: Grapevine
country: United States
facility: Teva Investigational Site 41
state: Texas
city: Lynchburg
country: United States
facility: Teva Investigational Site 23
state: Virginia
city: Ottawa
country: Canada
facility: Teva Investigational Site 6
city: Toronto
country: Canada
facility: Teva Investigational Site 7
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References: