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Monoclonal Antibodies

Umbralisib for Mantle Cell Lymphoma (CHOP U2 Trial)

Phase 1 & 2
Waitlist Available
Led By Amitkumar Mehta
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 3 years
Awards & highlights

CHOP U2 Trial Summary

This trial is testing a new drug, Umbralisib, to treat mantle cell lymphoma. The primary endpoint is the biological response rate of the combination of Umbralisib with other drugs. The study will expand to a phase II portion after safety is confirmed in phase I.

Eligible Conditions
  • Mantle Cell Lymphoma

CHOP U2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Complete Remission at the End of Induction Treatment
Secondary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)
Rate of Disease Control Rate (CR+PR+SD)
+2 more

CHOP U2 Trial Design

1Treatment groups
Experimental Treatment
Group I: phase 1b and phase 2Experimental Treatment2 Interventions
for phase 1 B portion, Ublitixumab will be given IV at dosage 900mg from Cycle 1 Day1 till cycle 6. If investigator decides to continue the treatment as maintenance, Ublitixumab will be given IV every 8 weeks for 24 months Umbralisib (800mg) will be given orally once a day within 30 minutes of a meal from Cycle 1 Day1 till cycle 6.If investigator decides to continue the treatment as maintenance,• Umbralisib will be given at orally daily for 24 months. Chemotherapy combination of CHOP-cyclophosphamide IV 750mg/m2 for Age <70 years, 500 mg/m2 for Age>70 years doxorubicin IV 50mg/m2for Age <70 years, 25 mg/m2 for Age>70 years , and vincristine IV 1mg/m2 (max 2mg)) are administered on Cycle 1 day 1 till Cycle 6. Prednisone 50-100mg will be given orally on days 1 through 5 of every cycle. For Phase II portion- Once Umbralisib dose is defined in phase Ib, the study will expand to phase II portion after SMC/DSMB (Safety monitoring committee/Data Safety Monitoring Committee) agrees.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbralisib
FDA approved
Ublituximab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,353 Total Patients Enrolled
Amitkumar MehtaPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
Amitkumar Mehta, MD 2021. "Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04692155.
~0 spots leftby Apr 2025
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