A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients with Untreated High Risk Follicular Lymphoma
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.
Disease Group: Lymphoma
Treatment Agent: Bendamustine HCl
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: n/a
Sponsor: Cephalon Oncology
Return Visit: Screening, Cycles 1-6, Days 1,2,8,15,22. End of Treatment, Follow-up and End of Study.
Home Care: n/a
Primary objectives · To evaluate the complete response rate of the combination of bendamustine, mitoxantrone, and rituximab in previously untreated follicular non-Hodgkin’s lymphoma. Secondary study objectives · To evaluate the toxicity and safety of BMR in patients with untreated follicular lymphoma. · To determine the time to progression (TTP) in patients with untreated follicular lymphoma following treatment with BMR. To evaluate the overall response rate of the combination of bendamustine, mitoxantrone, and rituximab in previously untreated follicular non-Hodgkin’s lymphoma. Exploratory objectives · To determine the correlation between molecular complete response and response to therapy. · To examine the immediate and prolonged effects of BMR on immune effector cell number and function.
IRB Review and Approval Date: 09/24/2008
Recruitment Status: Not Accepting
Projected Accrual: N/A
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) 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 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 mIU/mL within 10 to 14 days prior to study entry.
10) An ejection fraction of >/= 50% as documented by a cardiac function study.
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.