Follicular Lymphoma Clinical Trial
Official title:
A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
Verified date | April 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Cephalon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab) | To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. | 3 months | |
Secondary | Participants With Adverse Events | To evaluate the toxicity and safety of BMR in participants with untreated follicular lymphoma. | 3 months | |
Secondary | Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 5 months |
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