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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
Must not have
Prior treatment with a PI3K inhibitor
Clinically significant history of liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of two drugs, parsaclisib and romidepsin, for patients with T-cell lymphomas that have returned or not responded to standard treatments. Romidepsin stops cancer cells from dividing, while parsaclisib blocks a pathway that helps cancer cells grow. The goal is to find the best dose and see how well this combination works in reducing cancer and improving patient survival.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a PI3K inhibitor before.
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I have a significant history of liver problems.
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I have recently used medication that weakens my immune system.
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My brain or spinal cord disease is not under control.
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I cannot swallow pills or have major stomach problems.
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I have not received a live vaccine in the last 30 days.
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I am not taking strong CYP3A4 inhibitors or inducers.
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I am currently taking medication for an infection.
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My condition worsened while on romidepsin or soon after stopping it.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) of parsaclisib
Secondary study objectives
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
44%
Nausea
41%
Cough
41%
Diarrhoea
41%
Vomiting
33%
Fatigue
33%
Constipation
26%
Neutropenia
26%
Dizziness
22%
Arthralgia
22%
Headache
22%
Abdominal pain
19%
Thrombocytopenia
19%
Hypotension
15%
Dyspnoea
15%
Hypokalaemia
15%
Hypophosphataemia
15%
Oedema peripheral
15%
Oropharyngeal pain
15%
Upper respiratory tract infection
15%
Chills
15%
Back pain
15%
Tachycardia
15%
Anaemia
15%
Decreased appetite
11%
Sinusitis
11%
Aspartate aminotransferase increased
11%
Dehydration
11%
Hyperglycaemia
11%
Myalgia
11%
Palpitations
11%
Pruritus
11%
Stomatitis
11%
Electrocardiogram QT prolonged
11%
Muscle spasms
11%
Muscular weakness
11%
Night sweats
11%
Peripheral swelling
11%
Candida infection
11%
Dry skin
11%
Pneumonia
7%
Urinary tract infection
7%
Alanine aminotransferase increased
7%
Anxiety
7%
Blister
7%
Hypoalbuminaemia
7%
Neck pain
7%
Pain
7%
Pain in extremity
7%
Pyrexia
7%
Rash
7%
Rash papular
7%
Wheezing
7%
Bronchitis
7%
Abdominal distension
7%
Nasal congestion
7%
Platelet count decreased
7%
Asthenia
7%
Blood alkaline phosphatase increased
7%
Dysgeusia
7%
Fall
7%
Insomnia
7%
Nasopharyngitis
7%
Weight increased
4%
Contusion
4%
Dermatitis exfoliative
4%
Acute kidney injury
4%
Confusional state
4%
Leukocytosis
4%
Mental status changes
4%
Pleural effusion
4%
Renal tubular necrosis
4%
Respiratory failure
4%
Syncope
4%
Urinary incontinence
4%
Abdominal discomfort
4%
Herpes zoster
4%
Hypercalcaemia
4%
Hypertension
4%
Paraesthesia
4%
Respiratory tract congestion
4%
Rhinorrhoea
4%
Seasonal allergy
4%
Taste disorder
4%
Tinnitus
4%
Transaminases increased
4%
Upper-airway cough syndrome
4%
White blood cell count decreased
4%
Anal incontinence
4%
Hip fracture
4%
Malignant pleural effusion
4%
Haematuria
4%
Neuropathy peripheral
4%
Neutrophil count decreased
4%
Pain in jaw
4%
Weight decreased
4%
Bacteraemia
4%
Gastritis erosive
4%
Depression
4%
Drug hypersensitivity
4%
Erythema
4%
Hyperhidrosis
4%
Vaginal discharge
100%
80%
60%
40%
20%
0%
Study treatment Arm
Parsaclisib 30 mg QD
Parsaclisib 20 mg QD
Parsaclisib 45 mg QD
Parsaclisib 20 mg QD + R-ICE
Parsaclisib 20 mg + Itacitinib 300 mg
Parsaclisib 30 mg + Itacitinib 300 mg
Total
Parsaclisib 15 mg QD + R-ICE
Parsaclisib 5 mg QD
Parsaclisib 10 mg QD
Parsaclisib 15 mg QD

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: 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
2017
Completed Phase 2
~680

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.

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
293,305 Total Patients Enrolled
Walter HanelLead Sponsor
John C Reneau, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Parsaclisib (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04774068 — Phase 1
T-Cell and NK-Cell Non-Hodgkin Lymphoma Research Study Groups: Treatment (romidepsin, parsaclisib)
T-Cell and NK-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT04774068 — Phase 1
Parsaclisib (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774068 — Phase 1
~0 spots leftby Dec 2024