Interrogating Biological Signaling Pathway Dysregulations and In Vitro Screening With Personalized Therapies in Relapsed or Refractory Mantle Cell Lymphoma, MCL MATCH Trial

Korábbi kezelés

• The patient has a prior or concurrent malignancy that, in the opinion of the investigator, presents a greater risk to the patient's health and survival than the MCL, with a life expectancy ≤ 1 year.
• Prior chemotherapy within 2 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 2 weeks, radio- or toxin-immunoconjugates within 2 weeks, radiation therapy or other investigational agents within 1 week, major surgery within 4 weeks, or vaccination with live attenuated vaccines within 4 weeks of the first dose of start of assigned therapy.

Más betegség

• Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection, active hemorrhage, and psychiatric illness.
• Patient with rapid progressive disease, warranting urgent immediate admission.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent, or any cardiac disease defined by the New York Heart Association Classification as Class 3 (moderate) or 4 (severe).
• The patient receives corticosteroids for non-malignant conditions (e.g., asthma, inflammatory bowel disease) equivalent to a dexamethasone dose ≥ 4 mg/day or prednisone ≥ 20 mg/day.

Laborértékek

• Known HIV infection or active hepatitis B infection (not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI-Hepatology consultation.

Egyéb

• Pregnant or breastfeeding females.

• Confirmed MCL tissue diagnosis with CD20- and Cyclin D1-positive cells or cyclin D1 negative but t (11;14) positive and diagnosis confirmed by pathologist from the tissue biopsy.
• Patients must have relapsed/refractory MCL.
• Understand and voluntarily sign an IRB-approved informed consent form.
• Patients must have a biopsy-accessible lesion and be willing to undergo biopsy.
• Patients must have bi-dimensional measurable disease per Cheson criteria (bone marrow or GI-only involvement is acceptable).
• Age ≥ 18 years at the time of signing the informed consent.
• Absolute neutrophil count ≥ 1.0 x 109/L, absolute lymphocyte count ≥ 0.6 x 109/L, platelet count ≥ 50 x 109/L
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Patients must have adequate organ function for drugs(s) or combination being utilized (dependent on the drug (s) being given, the acceptable values of clinical parameters are given below: Biochemical values should be within the following limits:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Creatinine clearance (CLcr) > 30 mL/min
• Cardiac ejection fraction ≥ 50% by ECHO or MUGA.
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. Men must agree not to father a child and agree to use a condom if his partner is of child-bearing potential.