A phase II trial to study the efficacy and safety of a new drug P276-00 in the treatment of Mantle Cell Lymphoma
- Conditions
- Health Condition 1: null- Mantle Cell Lymphoma
- Registration Number
- CTRI/2009/091/000771
- Lead Sponsor
- Piramal Life Sciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 25
1. Age >/=18 years
2. 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
3. Documented progression or relapse after at least 1 line of prior chemotherapy
4. Presence of measurable disease
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. Life expectancy of at least 3 months
7. Ability to understand and the willingness to sign a written informed consent document (ICD)
8. Full recovery from all prior treatment toxicities to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
1. Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
2. 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.
3. Prior allogeneic stem cell transplantation within 1 year of study drug administration
4. Current or prior CNS lymphoma
5. QTc 450 msec
6. Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration
7. Presence of active and serious comorbidity and uncontrolled illness other than MCL
8. 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
9. Hemoglobin 8.0 gm/dL
10. Absolute neutrophil count 1000/mm3
11. Platelet count 50,000/mm3
12. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 Ã? institutional upper limit of normal (ULN) ( 5 Ã? institutional ULN if liver is involved with lymphoma or if patient has Gilberts Disease)
13. Total bilirubin, 1.5 Ã? institutional ULN ( 3 Ã? institutional ULN if liver is involved with lymphoma or if patient has Gilberts Disease)
14. Serum creatinine 1.5 Ã? institutional ULN
15. Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
16. Pregnant or lactating women
17. Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (1 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method