What side effects are associated with this type of intervention?

Romidepsin, a Histone Deacetylase Inhibitor, is commonly associated with side effects such as nausea, vomiting, fatigue, infections, and hematologic abnormalities like thrombocytopenia and neutropenia. Parsaclisib, a PI3K Inhibitor, may cause side effects including diarrhea, colitis, hyperglycemia, hypertension, and liver enzyme abnormalities. Both treatments require careful monitoring due to their potential for serious adverse effects.

What prior FDA approvals exist?

Romidepsin, a histone deacetylase inhibitor, has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL). Another histone deacetylase inhibitor, Vorinostat, is also FDA-approved for CTCL. While Parsaclisib, a PI3K inhibitor, is still under investigation, other PI3K inhibitors like Duvelisib have been approved for certain types of lymphomas, though not specifically for CTCL. These approvals highlight the ongoing exploration of targeted therapies in the treatment of CTCL.

What other types of research exist?

Promising novel alternatives for CTCL treatment in 2024 include Brentuximab Vedotin (an antibody-drug conjugate targeting CD30), Mogamulizumab (a monoclonal antibody targeting CCR4), and Pembrolizumab (a PD-1 inhibitor). These agents have shown efficacy in clinical trials and offer different mechanisms of action compared to Romidepsin and Parsaclisib.

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PI3K inhibitor

Romidepsin + Parsaclisib for Lymphoma

Phase 1

Waitlist Available

Led By John C Reneau, MD, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Biopsy proven diagnosis of PTCL or CTCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it's more effective than standard treatment for T-cell lymphomas.

Who is the study for?

Adults with relapsed or refractory T-cell lymphomas, including various subtypes like Anaplastic Large Cell and Cutaneous T-Cell Lymphoma. Participants must have a life expectancy of at least 90 days, adequate organ function, no recent cancer treatments (with some exceptions for steroids), and not be pregnant. They should agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the combination of Romidepsin and Parsaclisib to find the best dose for treating T-cell lymphomas that haven't responded well to other treatments. It aims to see if this combo can achieve complete remission or significant reduction in cancer size and improve patient survival.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation, liver enzyme changes, blood cell count variations which could affect infection risk or cause fatigue, gastrointestinal issues such as nausea or diarrhea, and possible heart rhythm abnormalities.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with PTCL or CTCL through a biopsy.

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My cancer is at least stage IB and affects more than 10% of my body or is a type that has spread to my lymph nodes or other areas.

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My condition is mycosis fungoides with large cell transformation.

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I can take care of myself and perform daily activities.

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My PTCL cancer returned or didn't respond after treatment, including brentuximab for ALCL.

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My CTCL cancer has worsened after at least 2 skin treatments or 1 body-wide treatment.

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My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) of parsaclisib

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Overall response rate (ORR)

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 88 Patients • NCT02018861

63%

Fatigue

50%

Cough

38%

Upper respiratory tract infection

38%

Nausea

25%

Hypertension

25%

Hyperglycaemia

25%

Diarrhoea

25%

Tachycardia

25%

Oral herpes

13%

Hyperlipidaemia

13%

Hepatic steatosis

13%

Myalgia

13%

Anxiety

13%

Herpes zoster

13%

Neuropathy peripheral

13%

Pyrexia

13%

Radiculopathy

13%

Headache

13%

Paraesthesia

13%

Alanine aminotransferase increased

13%

Bradycardia

13%

Hypokalaemia

13%

Respiratory tract congestion

13%

Acute kidney injury

13%

Pain

13%

Neutropenia

13%

Night sweats

13%

Sinusitis

13%

Aspartate aminotransferase increased

13%

Hypophosphataemia

13%

Abdominal distension

13%

Haematuria

13%

Hypotension

13%

Lacrimation increased

13%

Nasal congestion

13%

Neutrophil count decreased

13%

Oedema peripheral

13%

Productive cough

13%

Vertigo

13%

Wound

13%

Abdominal pain

13%

Blood alkaline phosphatase increased

13%

Dyspepsia

13%

Dyspnoea

13%

Malaise

13%

Paranasal sinus discomfort

13%

Renal impairment

13%

Blood creatinine increased

13%

Blood phosphorus increased

13%

Spinal cord compression

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Parsaclisib 20 mg + Itacitinib 300 mg

Parsaclisib 15 mg QD + R-ICE

Total

Parsaclisib 30 mg + Itacitinib 300 mg

Parsaclisib 20 mg QD + R-ICE

Parsaclisib 5 mg QD

Parsaclisib 10 mg QD

Parsaclisib 15 mg QD

Parsaclisib 20 mg QD

Parsaclisib 30 mg QD

Parsaclisib 45 mg QD

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (romidepsin, parsaclisib)Experimental Treatment2 Interventions

PRE-PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

2011

Completed Phase 2

~790

Parsaclisib

2018

Completed Phase 2

~280

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Romidepsin, a Histone Deacetylase (HDAC) inhibitor, works by blocking HDAC enzymes, leading to the activation of tumor suppressor genes and inducing apoptosis in cancer cells. Parsaclisib, a PI3K inhibitor, blocks the PI3K pathway, which is essential for cancer cell growth and survival, thereby reducing tumor growth and promoting cancer cell death. These targeted mechanisms are crucial for Cutaneous T-Cell Lymphoma patients as they offer more precise and potentially effective treatment options by directly interfering with pathways critical for cancer cell survival and proliferation.