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Personalized Therapy

Personalized Therapy for Mantle Cell Lymphoma

N/A

Recruiting

Led By Luhua (Michael) Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patient with rapid progressive disease, warranting urgent immediate admission

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial collects and tests samples to find personalized treatments for mantle cell lymphoma patients who have relapsed or are refractory to current treatment.

Who is the study for?

This trial is for adults with relapsed or refractory Mantle Cell Lymphoma (MCL) who have measurable disease and are willing to undergo a biopsy. They must have proper liver, kidney, heart function, and blood counts within specific ranges. Women of childbearing age must test negative for pregnancy, and men must use contraception. Exclusions include pregnant/breastfeeding women, uncontrolled medical conditions like hypertension or diabetes, certain infections like HIV or active hepatitis B, recent treatments with chemotherapy or other drugs.

What is being tested?

The MCL MATCH Trial aims to collect biological samples from patients with MCL to perform genetic testing. The goal is to identify personalized therapies based on the genetic mutations found in individuals whose cancer has not responded well to standard treatment options such as BTK inhibitors.

What are the potential side effects?

Since this trial involves biospecimen collection and follow-up rather than direct drug intervention at this stage, typical side effects associated with medications are not applicable here. However, there may be risks related to the biopsy procedure itself such as pain, bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My Mantle Cell Lymphoma diagnosis is confirmed with specific cell markers.

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I am 18 years old or older.

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My MCL cancer has returned or didn't respond to treatment.

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I am willing to have a biopsy of my cancer that can be easily reached.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is worsening quickly and I need urgent care.

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I take steroids equivalent to or more than 4 mg of dexamethasone or 20 mg of prednisone daily for a non-cancer condition.

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I do not have any serious health issues that would stop me from participating safely.

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I do not have serious heart problems like recent heart attacks or uncontrolled heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility rate

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

+1 more

Other study objectives

Correlation of somatic mutations in mantle cell lymphoma with cell signaling dysregulated activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (biospecimen collection)Experimental Treatment2 Interventions

Patients undergo blood, saliva or tissue sample collection for mRNA analysis and drug efficacy testing. Patients assigned treatment per the results are followed every 1 cycle of therapy for 1 year, every 2 months for 1 year, every 4 months for 1 year then every 6 months thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 10Eligibility criteria met