Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT00901927
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00901927
Study Brief:
Protocol Section:
NCT00901927