Zydelig Maintenance for Non-Hodgkin's Lymphoma

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: CNS lymphoma, HIV, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 year

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study to learn how safe and how effective the study drug Zydelig works, after autologous stem cell transplant as a maintenance therapy in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).

Research Team

Jean Yared, MD

Principal Investigator

University of Maryland Greenebaum Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 with certain types of B-cell non-Hodgkin's lymphoma who've had a stem cell transplant. They should be stable or improving post-transplant, able to use contraception, and have normal organ function. Excluded are those recently on other treatments, with severe lung disease, active infections, liver issues, or unable to take pills.

Inclusion Criteria

I am older than 18 years.

I am not completely bedridden.

I am eligible for high dose chemotherapy followed by stem cell transplant.

Exclusion Criteria

I cannot swallow pills.

I have severe lung disease and need oxygen or can't walk 50 feet without resting.

My condition worsened after taking Zydelig.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Zydelig at 150 mg twice daily continuously on 28-day cycles for maintenance therapy

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 years

Treatment Details

Interventions

• Zydelig

Trial Overview The study tests Zydelig as a maintenance therapy after autologous stem cell transplantation in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma. It aims to determine the safety and effectiveness of this drug in preventing cancer recurrence.

Participant Groups

Group I: Oral Zydelig 150 mg BID Experimental Treatment 1 Intervention

Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

University of Miami Sylvester Comprehensive Cancer Center

Collaborator

Trials

11

Recruited

2,700+