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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility rate

Secondary outcome measures

Duration of response

Incidence of adverse events

Overall survival

+2 more

Other outcome measures

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

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 2

~1730

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,301 Total Patients Enrolled

Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center

14 Previous Clinical Trials

592 Total Patients Enrolled

Luhua (Michael) Wang, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Personalized Therapies (Personalized Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04872413 — N/A

Mantle Cell Lymphoma Research Study Groups: Screening (biospecimen collection)

Mantle Cell Lymphoma Clinical Trial 2023: Personalized Therapies Highlights & Side Effects. Trial Name: NCT04872413 — N/A

Personalized Therapies (Personalized Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04872413 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this research encompassing the patient population?

"Affirmative. The clinical trial, which was initially listed on March 4th 2021 is still searching for eligible participants. A total of 20 volunteers are sought from one medical centre and the study details were most recently revised on October 14 2022 according to clinicaltrials.gov."

Answered by AI

Is the enrollment process still active for this research endeavor?

"According to the information on clinicaltrials.gov, this medical trial is still recruiting participants and has been since March 4th 2021 when it was first posted. It was last revised on October 14th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Interrogating Biological Signaling Pathway Dysregulations and In Vitro Screening With Personalized Therapies in Relapsed or Refractory Mantle Cell Lymphoma, MCL MATCH Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04872413.

All > Mantle Cell Lymphoma