A Study to Evaluate the Effectiveness and Safety of P276-00 for Mantle Cell Lymphoma that has Returned and/or is Resistant to Treatment

Overview

About this study

The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age ≥18 years
  • Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t 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 rituximab treatment within 3 months and 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
  • 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 after signing the ICD, during the entire study, and for at least 4 weeks following withdrawal from the study
    • One must be a barrier method

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions