Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Bendamustine; Mitoxantrone; Rituximab
Intervention description: Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.; 10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.; 375 mg/m^2 by vein over several hours on Day 1 of each cycle.
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Non-Hodgkin's Lymphoma; Untreated High Risk Follicular Lymphoma; Bendamustine hydrochloride; Bendamustine HCI; Bendamustine; CEP-18083; SDX-105; Treanda; Mitoxantrone; Novantrone; Rituximab; Rituxan

Summary:

      The goal of this clinical research study is to learn if the combination of bendamustine
      hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.

      The safety of this drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years at the time of signing the informed consent form.

          2. Able to adhere to the study visit schedule and other protocol requirements.

          3. Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.

          4. At least one measurable lesion according to the International Working Group Criteria
             for Response, of greater that 1.5cm.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of < 2 at study entry.

          6. Laboratory test results within these ranges: Absolute neutrophil count >/=1.5 x
             10^9/L; Platelet count >/=100 x 10^9/L; Serum creatinine </= 2.0 mg/dL; Total
             bilirubin </= 1.5 mg/dL; AST (SGOT) and ALT (SGPT) </= 2 x upper limit of normal (ULN)
             or </= 5 x ULN if hepatic metastases are present.

          7. Disease free of prior malignancies for at least 5 years with exception of currently
             treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the
             cervix or breast.

          8. Have a high risk FLIPI score, as defined by a FLIPI score >/= 3.

          9. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 to
             14 days prior to study entry.

         10. An ejection fraction of >/= 50% as documented by a cardiac function study.

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Pregnant or breast feeding females.

          3. 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.

          4. Use of any prior chemotherapy for follicular lymphoma.

          5. Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.

          6. A history of congestive heart failure.

          7. Any prior use of bendamustine or mitoxantrone.

          8. Concurrent use of other anti-cancer agents or experimental treatments.

          9. Known positive for HIV or infectious hepatitis type B or C.

         10. Creatinine clearance less than 40 ml/min.

         11. A known history of hepatic insufficiency (patients with a history of fulminate hepatic
             failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).

         12. Any history of grade 3b follicular lymphoma.