Status:
COMPLETED
Interrogating Biological Signaling Pathway Dysregulations and In Vitro Screening With Personalized Therapies in Relapsed or Refractory Mantle Cell Lymphoma, MCL MATCH Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial collects and tests samples using genetic testing to find personalized treatments that may work best for patients with mantle cell lymphoma (MCL) that has come back (relapsed) or do...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the feasibility of the proposed therapy based on dysregulated cell signaling pathways in combination with in vitro drug activity. SECONDARY OBJECTIVES: I. Overall ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Pregnant or breastfeeding females.
- 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.
- 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.
- 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).
- 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.
- 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.
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04872413
Start Date
March 4 2021
End Date
February 21 2025
Last Update
February 26 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030