24 Participants Needed

ATRA + Pembrolizumab for Lymphoma

Recruiting at 1 trial location
KW
KT
Overseen ByKat Ton, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.

Will I have to stop taking my current medications?

The trial requires you to stop taking Vitamin A supplements and certain medications that affect liver enzymes (CYP3A modulators) at least 3 days before starting the treatment and during the trial. If you're on a micro-dosed progesterone contraceptive, you'll need to switch to another form of birth control.

What data supports the effectiveness of the drug combination ATRA and Pembrolizumab for treating lymphoma?

Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has been effective in treating various cancers, including melanoma and Hodgkin's lymphoma. ATRA, when combined with pembrolizumab, has shown promise in treating melanoma, suggesting potential benefits for other cancers like lymphoma.12345

Is the combination of ATRA and Pembrolizumab safe for humans?

Research on ATRA (All-trans retinoic acid) combined with other treatments like interferon shows that it generally has a manageable safety profile, with some studies reporting negligible side effects. However, specific safety data for the combination of ATRA and Pembrolizumab is not available in the provided research.678910

How is the drug combination of ATRA and Pembrolizumab unique for treating lymphoma?

The combination of ATRA and Pembrolizumab is unique because it targets the immune system in a novel way by combining a retinoic acid (ATRA) that influences cell differentiation with an immune checkpoint inhibitor (Pembrolizumab) that helps T cells attack cancer cells. This approach is different from standard treatments as it leverages both immune modulation and direct cancer cell targeting.1341112

Research Team

RA

Rita Assi, MD

Principal Investigator

Indiana University

Eligibility Criteria

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.

Inclusion Criteria

My Hodgkin's lymphoma or B-cell non-Hodgkin's lymphoma has returned or is not responding to treatment.
Willingness to comply with all study procedures and be available for the duration of the trial
I can take care of myself and am up and about more than half of my waking hours.
See 8 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.
Known history of Human Immunodeficiency Virus (HIV)
Known sensitivity to retinoic acid derivatives
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200mg Q3W pembrolizumab treatment plus 150 mg/m2 ATRA orally for 3 days surrounding each of the first four infusions

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
1 visit (in-person)

Treatment Details

Interventions

  • ATRA
  • Pembrolizumab
Trial Overview 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.
Participant Groups
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).

ATRA is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tretinoin for:
  • Acute promyelocytic leukemia (APL)
🇪🇺
Approved in European Union as Tretinoin for:
  • Acute promyelocytic leukemia (APL)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rita Assi

Lead Sponsor

Trials
1
Recruited
20+

Findings from Research

Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]
In a phase II trial involving 24 patients with advanced mycosis fungoides or Sézary syndrome, pembrolizumab showed an overall response rate of 38%, with two complete responses and seven partial responses, indicating its efficacy in treating these conditions.
The treatment had a favorable safety profile, with immune-related adverse events leading to discontinuation in only four patients, and while 53% experienced a temporary worsening of skin symptoms, this did not result in treatment discontinuation and was associated with high PD-1 expression on Sézary cells.
Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study.Khodadoust, MS., Rook, AH., Porcu, P., et al.[2021]
The combination of all-trans retinoic acid (ATRA) and pembrolizumab was well tolerated in a phase Ib/II trial with 24 patients, establishing a recommended phase II dose of 150 mg/m2 ATRA plus 200 mg pembrolizumab every three weeks.
This treatment showed a high overall response rate of 71%, with 50% of patients achieving a complete response and a median progression-free survival of 20.3 months, indicating its potential as an effective frontline therapy for advanced melanoma.
Targeting MDSC Differentiation Using ATRA: A Phase I/II Clinical Trial Combining Pembrolizumab and All-Trans Retinoic Acid for Metastatic Melanoma.Tobin, RP., Cogswell, DT., Cates, VM., et al.[2023]

References

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study. [2021]
Targeting MDSC Differentiation Using ATRA: A Phase I/II Clinical Trial Combining Pembrolizumab and All-Trans Retinoic Acid for Metastatic Melanoma. [2023]
Pembrolizumab: first global approval. [2021]
Pembrolizumab versus the standard of care for relapsed and refractory classical Hodgkin's lymphoma progressing after brentuximab vedotin: an indirect treatment comparison. [2019]
Phase I/II study of intermittent all-trans-retinoic acid, alone and in combination with interferon alfa-2a, in patients with epidemic Kaposi's sarcoma. [2018]
Clinical Availability of ATRA for Patients With Suspected Acute Promyelocytic Leukemia: Why Guidelines May Not Be Followed. [2023]
[Treatment of cutaneous T-cell lymphoma with retinoid receptor X-selective ligands: endocrine and metabolic disorders]. [2019]
Activity of interferon-alpha and isotretinoin in patients with advanced, refractory lymphoid malignancies. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment of cutaneous T cell lymphoma with a combination of low-dose interferon alfa-2b and retinoids. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Pembrolizumab for the treatment of diffuse large B-cell lymphoma. [2020]
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