Status:
TERMINATED
Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Cephalon
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 com...
Detailed Description
The Study Drugs: Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells. Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells fr...
Eligibility Criteria
Inclusion
- Age \>18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.
- At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 at study entry.
- 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.
- 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.
- Have a high risk FLIPI score, as defined by a FLIPI score \>/= 3.
- 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.
- An ejection fraction of \>/= 50% as documented by a cardiac function study.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- 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.
- Use of any prior chemotherapy for follicular lymphoma.
- Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
- A history of congestive heart failure.
- Any prior use of bendamustine or mitoxantrone.
- Concurrent use of other anti-cancer agents or experimental treatments.
- Known positive for HIV or infectious hepatitis type B or C.
- Creatinine clearance less than 40 ml/min.
- A known history of hepatic insufficiency (patients with a history of fulminate hepatic failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).
- Any history of grade 3b follicular lymphoma.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00901927
Start Date
May 1 2009
End Date
January 1 2016
Last Update
April 3 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030