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ATRA + Pembrolizumab for Lymphoma

Phase 2

Recruiting

Led By Rita Assi, MD

Research Sponsored by Rita Assi

Eligibility Criteria Checklist

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

Must have

Patients with histologically proven, relapsed or refractory HL or B-NHL as specified

Have a performance status of 0 to 2 on the ECOG Performance Scale

Must not have

Receipt of live vaccine within 30 days of planned start of study therapy

Known active Hepatitis B or Hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, before cycle 2, before cycle 4, and within 60 days after cycle 4 day 1

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment for patients with relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma. The treatment involves a combination of A

Who is the study for?

This trial is for people with certain types of lymphoma (Hodgkin's and B-Non-Hodgkin's) that have come back or didn't respond to previous treatments. Specific eligibility details are not provided, but typically participants would need a confirmed diagnosis and may be required to meet other health criteria.

What is being tested?

The study is testing the effectiveness of combining two drugs: ATRA (a vitamin A derivative) and Pembrolizumab (an immunotherapy drug), in treating relapsed Hodgkin Lymphoma and B-Non-Hodgkin Lymphoma. It's an open-label trial, meaning both researchers and participants know what treatment is being given.

What are the potential side effects?

Possible side effects from Pembrolizumab can include fatigue, itching, rash, diarrhea, joint pain, or flu-like symptoms. ATRA might cause dry skin, headaches, dizziness or increased sensitivity to sunlight. The combination of these drugs could potentially amplify these effects.

Eligibility Criteria

Inclusion Criteria

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

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My Hodgkin's lymphoma or B-cell non-Hodgkin's lymphoma has returned or is not responding to treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not received a live vaccine in the last 30 days.

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I have an active Hepatitis B or C infection.

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I have cancer that has spread to my brain or its coverings.

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I cannot use ATRA due to health reasons.

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I received a COVID vaccine or booster within 4 weeks before starting treatment.

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I have a history of or currently have non-infectious lung inflammation.

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I do not have any ongoing serious infections requiring treatment.

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I use a low-dose progesterone contraceptive and am not open to changing it.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have an active tuberculosis infection.

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I am not on any medication that is not allowed in the study.

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My physical ability has significantly declined just before treatment.

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I have an immune system disorder or have taken steroids in the past week.

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I have had a stem cell or solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, before cycle 2, before cycle 4, and within 60 days after cycle 4 day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, before cycle 2, before cycle 4, and within 60 days after cycle 4 day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, before cycle 2, before cycle 4, and within 60 days after cycle 4 day 1 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events

Secondary study objectives

Patient derived myeloid-derived suppressor cells (MDSC)

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: ATRA and PembrolizumabExperimental Treatment2 Interventions

Patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 ATRA orally for 3 days surrounding each of the first four infusions of pembrolizumab (day -1, day 0, day +1).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ATRA

1993

Completed Phase 4

~1250

Pembrolizumab

2017

Completed Phase 3

~2810