SCCA Lymphoma Clinical Trials
|Closed||Mantle Cell Lymphoma||Phase II||
The purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.
- Age ≥18 years
- Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping
- Documented progression or relapse after at least 1 line of prior chemotherapy
- Presence of measurable disease
- ECOG performance status 0, 1, or 2
- Life expectancy of at least 3 months
- Ability to understand and the willingness to sign a written informed consent document (ICD)
- Full recovery from all prior treatment toxicities of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1
- Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
- Prior treatment with monoclonal antibodies or any radio- or toxin- immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study.
- Prior allogeneic stem cell transplantation within 1 year of study drug administration
- Current or prior CNS lymphoma
- QTc > 450 msec
- Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration
- Presence of active and serious comorbidity and uncontrolled illness other than MCL
- History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer
- Hemoglobin <8.0 gm/dL
- Absolute neutrophil count <1000/mm3
- Platelet count <50,000/mm3
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × institutional upper limit of normal (ULN) (> 5 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)
- Total bilirubin, >1.5 × institutional ULN (> 3 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)
- Serum creatinine >1.5 × institutional ULN
- Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
- Pregnant or lactating women
- Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (one of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.