Parsaclisib for Anaplastic Large Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anaplastic Large Cell Lymphoma+8 MoreParsaclisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Anaplastic Large Cell Lymphoma
  • Refractory Transformed Mycosis Fungoides
  • Cutaneous T-Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Non-Hodgkin's T-cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Day 28
Maximum tolerated dose (MTD) of parsaclisib
Month 100
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
Up to 2 years
Disease control rate (DCR)
Up to 24 weeks
Overall response rate (ORR)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Parsaclisib 10 mg QD
67%Upper respiratory tract infection
67%Pyrexia
67%Rash
33%Hypokalaemia
33%Dermatitis exfoliative
33%Night sweats
33%Bacteraemia
33%Drug hypersensitivity
33%Muscle spasms
33%Urinary tract infection
33%Diarrhoea
33%Vaginal discharge
33%Weight decreased
33%Psoriasis
33%Middle ear inflammation
33%Fatigue
33%Hypertension
33%Nausea
33%Sinusitis
33%Stomatitis
33%Abdominal tenderness
33%Alopecia
33%Basal cell carcinoma
33%Dry mouth
33%Dysphagia
33%Oedema peripheral
33%Pneumonia
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02018861) in the Parsaclisib 10 mg QD ARM group. Side effects include: Upper respiratory tract infection with 67%, Pyrexia with 67%, Rash with 67%, Hypokalaemia with 33%, Dermatitis exfoliative with 33%.

Trial Design

1 Treatment Group

Treatment (romidepsin, parsaclisib)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Parsaclisib · No Placebo Group · Phase 1

Treatment (romidepsin, parsaclisib)Experimental Group · 2 Interventions: Parsaclisib, Romidepsin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parsaclisib
Not yet FDA approved
Romidepsin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Walter HanelLead Sponsor
Ohio State University Comprehensive Cancer CenterLead Sponsor
287 Previous Clinical Trials
285,993 Total Patients Enrolled
Walter Hanel, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
John C Reneau, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
has a median overall survival of 18 months The median overall survival for biopsy proven diagnosis of PTCL or CTCL is 18 months.
In order to be eligible for this study, patients must have: 1) Relapsed/refractory PTCL, progressing after at least one line of systemic therapy (for anaplastic large cell lymphoma [ALCL], must have had prior treatment with brentuximab vedotin)
for allogeneic stem cell transplantation Mycosis fungoides with large cell transformation is a type of cancer that can be treated with allogeneic stem cell transplantation.
A blood test result of an absolute neutrophil count (ANC) of 1,000 or more per millimeter cubed is considered normal.
Stage IB CTCL or PTCL patients with a nodal area of at least 1.5 cm in long dimension, extranodal disease of at least 1 cm in long dimension, or fludeoxyglucose F-18 - positron emission tomography (FDG-PET) avid disease (Deauville score = 5) are candidates for this treatment.
The patient's platelet count is greater than or equal to 100,000 per milliliter.
The person is able to understand what they are consenting to and they are doing so voluntarily.
You have no performance status of 0-2.
The life expectancy of a patient is 90 days or more.