A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: P276-00
Intervention description: P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD inhibitor; Mantle Cell Lymphoma

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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