Featured Clinical Trial:

Non-Hodgkins lymphoma; Mantle cell lymphoma (product/compound: Bendamustine and Rituximab)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status: Enrollment closed.

Condition: Non-Hodgkin’s Lymphoma; Mantle Cell Lymphoma

Product Name/Compound: Bendamustine and Rituximab

Full Study Title: An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

Study Summary: To Compare the complete response (CR) rate at end of treatment of bendamustine and rituximab (BR) with either R-CVP or R-CHOP in the treatment of patients with advanced indolent non-hodgkin’s lymphoma or mantle cell lymphoma.

Eligible Participants:

Inclusion (Eligible):

• Histopathologic confirmation of one of the following CD20+ B-cell non-Hodgkin's lymphomas:
  • Follicular lymphoma (grade 1 or 2)
  • Immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)
  • Splenic marginal zone B-cell lymphoma
  • Extra-nodal marginal zone lymphoma of mucosa associated lymphoid tumor (MALT) type
  • Nodal marginal zone B-cell lymphoma
  • Mantle cell lymphoma
• Meets one of the following need-for-treatment criteria (with the exception of mantle cell lymphoma for which treatment is indicated):
  • Presence of at least one of the following B-symptoms:
    • Fever (>38ºC) of unclear etiology
    • Night sweats
    • Weight loss of greater than 10% within the prior 6 months
  • Large tumor mass (bulky disease)
  • Presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
  • Hyperviscosity syndrome due to monoclonal gammopathy
• CD20 positive B cells in lymph node biopsy or other lymphoma pathology specimen.
• No prior treatment.
• Bidimensionally measurable disease (field not previously radiated).
• Left ventricular ejection fraction (LVEF) ≥50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated with R-CHOP

Exclusion (Not Eligible):

• Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma.
• Transformed disease. Bone marrow blasts are permitted, however, transformed disease indicating leukemic involvement is not permitted.
• Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma.
• Prior radiation for NHL, except for a single course of locally delimited radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions.
• Active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatment.
• 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.
• Known human immunodeficiency virus (HIV) positivity.
• Active hepatitis B or hepatitis C infection (Hepatitis B surface antigen testing required).
• Corticosteroids for treatment of lymphoma within 28 days of study entry. Chronically administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted.
• Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy.
• Any other investigational agent within 28 days of study entry.
• Known hypersensitivity to bendamustine, mannitol, or other study-related drugs.
• The patient has Ann Arbor stage I disease.

Study Phase: Phase III (What are Phases?)

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Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT00877006

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