Status:
TERMINATED
A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma
Lead Sponsor:
Piramal Enterprises Limited
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Despite response rates of up to 97% with first-line standard or high-intensity chemotherapy, with or without stem-cell transplantation, most patients of mantle cell lymphoma (MCL)relapse.Prognosis of ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00843050
Start Date
November 1 2009
End Date
August 1 2012
Last Update
July 27 2012
Active Locations (20)
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1
Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona
Phoenix, Arizona, United States, 85054
2
Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona
Scottsdale, Arizona, United States, 85259
3
College of Medicine, Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601