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Parsaclisib for Non-Hodgkin's Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Hodgkin's Lymphoma+13 MoreParsaclisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug in combination with the standard drug therapy for high risk diffuse large B-cell lymphoma to see if it is more effective than the standard therapy alone.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Follicular Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Double Hit Lymphoma
  • Slow-Growing Non-Hodgkin's Lymphoma
  • Marginal Zone Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Ann Arbor Stage II Marginal Zone Lymphoma
  • Ann Arbor Stage III Marginal Zone Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From registration to death due to any cause, assessed up to 5 years

Year 5
Overall survival (Dose Expansion)
Year 5
Event-free survival (Dose Expansion)
Year 5
Progression-free survival (Dose Expansion)
Year 2
Duration of response (Dose Expansion)
Up to 2 years
Incidence of adverse events (AEs) (Phase I)
Incidence of adverse events (Dose Expansion)
Up to 21 days
Maximum tolerated dose (MTD) of parsaclisib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (Phase I)
Week 4
Complete metabolic response (CMR) rate (Dose Expansion)
Objective response rate (Dose Expansion)

Trial Safety

Safety Progress

1 of 3

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1
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1
Daratumumab
1
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Side Effects for

Parsaclisib 15 mg QD + R-ICE
100%Anaemia
75%Neutropenia
75%Thrombocytopenia
50%Headache
50%Hypokalaemia
50%Fluid overload
50%Alopecia
50%Dizziness
25%Febrile neutropenia
25%Tachycardia
25%Dyspnoea
25%Visual perseveration
25%Palpitations
25%Arthralgia
25%Syncope
25%Fatigue
25%Nausea
25%White blood cell count increased
25%Atrial flutter
25%Constipation
25%Sinus tachycardia
25%Dyspnoea exertional
25%Muscle spasms
25%Pruritus
25%Pulmonary oedema
25%Respiratory syncytial virus test positive
25%White blood cell count decreased
25%Wound infection bacterial
25%Nasal congestion
25%Oedema peripheral
25%Chills
25%Cough
25%Dermatitis acneiform
25%Night sweats
25%Oral pain
25%Supraventricular tachycardia
25%Tinnitus
25%Wound infection pseudomonas
25%Rash
25%Hypertension
25%Atrial fibrillation
25%Hypomagnesaemia
25%Influenza
25%Insomnia
25%Laryngeal inflammation
25%Pyrexia
25%Blood creatinine increased
25%Diarrhoea
25%Decreased appetite
25%Dysuria
25%Eye irritation
25%Muscle twitching
25%Neuropathy peripheral
25%Weight increased
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02018861) in the Parsaclisib 15 mg QD + R-ICE ARM group. Side effects include: Anaemia with 100%, Neutropenia with 75%, Thrombocytopenia with 75%, Headache with 50%, Hypokalaemia with 50%.

Trial Design

1 Treatment Group

Treatment (parsaclisib, R-CHOP)
1 of 1

Experimental Treatment

44 Total Participants · 1 Treatment Group

Primary Treatment: Parsaclisib · No Placebo Group · Phase 1

Treatment (parsaclisib, R-CHOP)Experimental Group · 7 Interventions: Doxorubicin Hydrochloride, Cyclophosphamide, Prednisone, Pegfilgrastim, Parsaclisib, Rituximab, Vincristine Sulfate · Intervention Types: Drug, Drug, Drug, Biological, Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Methylprednisolone
FDA approved
Filgrastim
FDA approved
Parsaclisib
Not yet FDA approved
Rituximab
FDA approved
Vincristine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from registration to death due to any cause, assessed up to 5 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,918 Previous Clinical Trials
3,506,936 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,811 Total Patients Enrolled
Yucai WangPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
45 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The cell has a high expression of Myc and Bcl-2.
MYC rearrangement can be identified through fluorescence in situ hybridization (FISH)
Lymphoma that is high-grade and has a rearrangement in the MYC gene, as well as a rearrangement in the BCL2 or BCL6 genes (double-hit or triple-hit lymphoma), but is not a candidate for more aggressive chemotherapy.
to the nearest millimeter The disease must be able to be measured through a CT scan or PET/CT scan, and must be at least 1.5 cm in one diameter
This is a description of a subtype of B-cell found in non-germinal centers, by the Hans algorithm.
defines a high-risk population A high-risk population is defined as a group of people with a myc expression level of >= 40% by immunohistochemistry (IHC).
The text states that if Bcl-2 expression is 50% or more by IHC, then the patient is likely to have a good prognosis.
Patients with a new diagnosis of DLBCL (a more aggressive type of lymphoma) and an indolent lymphoma (a less aggressive type of lymphoma) are eligible
chronic lymphocytic leukemia (CLL) are not candidates for radiotherapy Ann Arbor staged II, III, or IV chronic lymphocytic leukemia is not a candidate for radiotherapy.
References

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