RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bendamustine in treating patients who have rituximab-refractory indolent B-cell non-Hodgkin’s lymphoma.

Condition	Treatment or Intervention	Phase
adult non-Hodgkin's lymphoma indolent or aggressive adult non-Hodgkin's lymphoma	Drug: bendamustine  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the overall response (complete and partial response) rate in patients with rituximab-refractory indolent B-cell non-Hodgkin’s lymphoma treated with bendamustine.

Secondary

• Determine the safety profile of this drug in these patients.
• Determine progression-free survival of patients treated with this drug.
• Determine duration of response in patients treated with this drug.
• Determine the pharmacokinetic profile of this drug and its major metabolites in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive bendamustine IV over 30 minutes on days 1 and 2. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 22-72 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of indolent or transformed B-cell non-Hodgkin’s lymphoma, including any of the following subtypes:
• Follicular B-cell lymphoma
• Diffuse small cleaved cell lymphoma
• Diffuse small lymphocytic lymphoma
• No chronic lymphocytic leukemia
• Lymphoplasmacytic lymphoma
• Marginal zone lymphoma
• Refractory to single-agent or combination rituximab therapy, defined as no response or disease progression within 6 months of completing rituximab therapy
• At least 1 bidimensionally measurable lesion ≥ 2.0 cm in one dimension
• Must be outside of previously irradiated area
• No primary or active CNS lymphoma
• Prior CNS lymphoma allowed provided patient is neurologically stable with no progressive symptoms and is not receiving steroids or anticonvulsants
• At least 28 days since prior CNS treatment and recovered

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3*
• Platelet count ≥ 100,000/mm^3* NOTE: *Unless due to > 50% marrow involvement by lymphoma

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine clearance > 30 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No known hypersensitivity to mannitol
• No other active malignancy except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
• No serious infection
• No other medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• See Chemotherapy
• See Radiotherapy
• More than 3 weeks since prior immunotherapy and recovered
• More than 14 days since prior hematopoietic growth factors
• Chronic epoetin alfa allowed
• No concurrent bone marrow growth factors during the first course of study therapy

Chemotherapy

• No prior high-dose chemotherapy with allogeneic stem cell support
• No more than 3 prior chemotherapy regimens
• Retreatment with an identical regimen or agent does not count as a new regimen
• More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy

• See Disease Characteristics
• No concurrent therapeutic-dose systemic steroids

Radiotherapy

• See Disease Characteristics
• No prior radioimmunotherapy

Surgery

• Not specified

Other

• More than 28 days since prior investigational agents
• No other concurrent antitumor therapy

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-7059,  United States

Study chairs or principal investigators

Peter Rosen, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000367119; UCLA-0311059-01; SALMEDIX-SDX-105-01; NCT00085033
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085033
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08