Zydelig Maintenance for Non-Hodgkin's Lymphoma

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Zydelig to determine its safety and effectiveness for people with non-Hodgkin's lymphoma that hasn't worsened after a stem cell transplant. The goal is to use Zydelig as a maintenance treatment to prevent cancer recurrence. Individuals who have undergone a stem cell transplant and have not experienced lymphoma progression might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot take strong CYP3A4 inhibitors or inducers. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Zydelig is likely to be safe for humans?

Research shows that Zydelig has been tested in adults with a slow-growing type of non-Hodgkin lymphoma. Safety information comes from studies involving 146 patients. The most common side effects include low white blood cell counts in 53% of patients, increased liver enzymes in 50%, diarrhea in 47%, and tiredness in 30%. These side effects were usually manageable. The treatment aims to help prevent cancer from returning after a stem cell transplant. Although some side effects occur, previous studies suggest that the medication is generally well-tolerated in this context. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-Hodgkin's lymphoma, which often involve chemotherapy or monoclonal antibodies, Zydelig is unique because it targets a specific enzyme called PI3K delta. This enzyme plays a crucial role in the survival and proliferation of lymphoma cells. By inhibiting PI3K delta, Zydelig offers a more targeted approach that could potentially reduce the side effects associated with broader-acting therapies. Researchers are excited about Zydelig because it provides a novel mechanism of action that might improve outcomes for patients with indolent or transformed indolent B-cell NHL.

What evidence suggests that Zydelig might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that Zydelig may help treat certain types of non-Hodgkin's lymphoma. In earlier studies, it worked well for patients with a slow-growing form of this cancer, with 54% responding to the treatment. Additionally, after one year, 94% of patients did not experience disease progression, and many survived the first year. While these results are encouraging, the drug's effectiveness can vary. Ongoing research, including this trial where participants receive Zydelig as maintenance therapy, aims to better understand its benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Jean Yared, MD

Principal Investigator

University of Maryland Greenebaum Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/6354/528633/Idelalisib-ZydeligR-Maintenance-in-B-Cell-Non

Idelalisib (Zydelig®) Maintenance in B-Cell Non-Hodgkin's ...

The median PFS and OS with the 95% CI have not been reached yet. PFS at 1 yr and 2 yrs were 94% and 82% respectively. OS at 1 yr and 2 yrs were ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666636725006384

Idelalisib (Zydelig) Maintenance in B-Cell Non-Hodgkin's ...

Idelalisib (Zydelig®), the 1st marketed PI3Kδ inhibitor, has been effective against iNHL (FL) with favorable activity in treated pts, with an ORR of 54%, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03133221

Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma ...

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5395130/

Efficacy and safety of idelalisib in patients with relapsed ...

At data cutoff (June 11, 2014), complete response (CR) was achieved in 10 patients (13.9%), partial response (PR) in 30 patients (41.7%), and stable disease (SD) ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S000649712409181X

Idelalisib (Zydelig®) Maintenance in B-Cell Non-Hodgkin's ...

At the time of ASCT, 11 pts were in complete remission (CR) and 6 pts were in partial remission (PR). All pts achieved CR after ASCT. The median ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf

ZYDELIG (idelalisib) tablets, for oral use - accessdata.fda.gov

Summary of Clinical Trials in Indolent Non-Hodgkin Lymphoma. The safety data reflect exposure to Zydelig in 146 adults with indolent non-Hodgkin lymphoma ...

7.

gilead.com

gilead.com/-/media/files/pdfs/medicines/oncology/zydelig/zydelig_pi.pdf

Zydelig

The most common adverse reactions were neutropenia (53%), ALT increased (50%), diarrhea (47%), AST increased (41%), fatigue (30%), nausea and cough (29% each),.

8.

zydelig.com

zydelig.com/

ZYDELIG® (idelalisib) | Official Patient Website

ZYDELIG should not be used as the first medicine to treat anyone, including people with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and ...

9.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2802537

Clinical Trials Portfolio and Regulatory History of Idelalisib ...

In this systematic review and meta-analysis, we found 20 trials that investigated idelalisib in indolent non-Hodgkin lymphoma (NHL).