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Protocol No. UW16086

Principal Investigator Chang, Julie

Phase II

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Bendamustine + obinutuzumab induction chemoimmunotherapy with risk-adapted obinutuzumab maintenance therapy in previously untreated mantle cell lymphoma

Objective The purpose of this study is to see if treatment with bendamustine plus the drug obinutuzumab helps keep mantle cell lymphome (MCL) in remission longer than treatment with bendamustine and a similar drug called rituximab. Patients like you are usually treated using a combination of the chemotherapy drug called bendamustine (TREANDA®) and rituximab. Obinutuzumab (Gazyva®) is similar to rituximab, but more potent. We hope that combining bendamustine with obinutuzumab will result in better and longer lymphoma remissions compared with standard treatment with bendamustine and rituximab. We also want to see if a type of lab test called minimal residual disease (MRD) testing can predict how long remission will last after treatment. This very sensitive MRD test will help researchers better understand how response to cancer treatment can predict how long this treatment benefit will last. We will also use information from the MRD testing to decide how long you will continue with study treatment.

Treatment Both obinutuzumab and bendamustine are approved by the US Food and Drug Administration (FDA) for treatment of other diseases similar to MCL. However, neither drug is FDA-approved specifically to treat MCL. Using obinutuzumab with bendamustine to treat MCL is investigational. “Investigational” means that the FDA has not approved this combination of drugs for your type of cancer.

Description The first portion of the treatment is called the induction phase. You will get treatment in “cycles.” Each cycle lasts 28 days. The induction phase of treatment will be 6 cycles long. For Cycle 1 only, you will receive 4 days of intravenous (IV) treatment given in the clinic. On Days 1 and 2, you will receive both bendamustine IV and obinutuzumab IV. In Cycles 2-6, for each of the cycles on Day 1 you will receive bendamustine IV and obinutuzumab IV, and on Day 2 you will receive only bendamustine IV. Consolidation therapy will begin no later than 12 weeks after the last dose of induction chemotherapy and once your neutrophil (type of white blood cell) levels have returned to safe levels. The consolidation phase of treatment consists of one, 28-day cycle. You will receive obinutuzumab IV on Days 1, 8, 15, and 22 of this cycle. Approximately 4-6 weeks after you complete consolidation therapy, we will assess your response to treatment.

Key Eligibility
  • Age greater than or equal to18 years at the time of signing the informed consent document
  • Histologically confirmed mantle cell lymphoma
  • Subjects must have at least one bi-dimensionally measurable lesion
  • No prior cytotoxic chemotherapy; prior therapy with single-agent rituximab is permitted
  • Prior involved-field radiotherapy to symptomatic nodal sites of involvement is also permitted
  • Prior therapy with rituximab is permitted, even in the setting of rituximab-refractory disease
  • Patients must not be eligible for more intensive cytotoxic chemotherapy or consolidative autologous stem cell transplant OR subject has been informed of the risks and benefits of intensive chemotherapy and autologous stem cell transplant for treatment of mantle cell lymphoma and has refused this option
  • Subjects are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement
  • Patients are not eligible if on current use of other anti-cancer agents or treatments
  • Patients are not eligible if they have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment
  • Patients are not eligible if they have had a prior malignancy, except for adequately treated basal cell or squamous cell skin cancer in situ cervical or breast cancer, or other cancer from which the subject has been disease free for at least 2 years
  • Patients are not eligible if they have had severe or life-threatening anaphylaxis or hypersensitivity reaction when previously exposed to rituximab or other mAb therapy
  • Patients are not eligible if known to be positive for HIV or infectious hepatitis (type B or C)
  • Patients are not eligible if pregnant or breast-feeding
  • Patients are not eligible if they have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Applicable Disease Sites Lymphoma

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved Obinutuzumab; RO5072759 (Obinutuzumab); SDX-105 (bendamustine); Treanda (bendamustine); bendamustine

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park