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Zydelig Maintenance for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Jean Yared, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Age >18

ECOG performance status <4

Must not have

Patients who are unable to swallow pills

Patients with moderate to severe lung disease including those requiring O2 supplementation, unable to walk 50 feet without stopping to rest, and moderate to severe obstructive or restrictive disease of the lung

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1- and 2-year progression-free survival

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective in treating lymphoma after a stem cell transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Zydelig may cause side effects like diarrhea, fever, fatigue, coughing, nausea; it can also lead to serious conditions such as liver toxicity, severe skin reactions and intestinal perforation among others.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I am not completely bedridden.

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

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My liver and kidney functions are within the normal range required by the trial.

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My cancer is one of the specified types of non-Hodgkin lymphoma.

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I am 30-120 days post stem cell transplant with stable or improving cancer and recovered blood counts.

Exclusion Criteria

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

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I cannot swallow pills.

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

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My condition worsened after taking Zydelig.

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I have inflammatory bowel disease.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have active or untreated brain lymphoma.

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I am not taking any strong medications that could interfere with the trial drugs.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks.

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I have liver disease, cirrhosis, or a hepatitis B/C infection.

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I am not pregnant, nursing, nor planning to become pregnant or nurse during the study.

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I have been diagnosed with diffuse large B-cell lymphoma from the start.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1- and 2-year progression-free survival

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1- and 2-year progression-free survival

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1- and 2-year progression-free survival for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year

Secondary study objectives

Progression-free Survival at 1 and 2 Years After Autologous Stem Cell Transplantation.

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: Oral Zydelig 150 mg BIDExperimental Treatment1 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.

0 / 18Eligibility criteria met