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PI3K Inhibitor

Tafasitamab + Parsaclisib for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia (topMIND Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)

Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL

Must not have

Clinically significant cardiac disease

Other malignancy within the past 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two drugs are safe to use together to treat certain B-cell cancers.

Who is the study for?

Adults with relapsed or refractory B-cell malignancies, such as certain types of non-Hodgkin's lymphoma or chronic lymphocytic leukemia, who have tried at least two prior treatments including an anti-CD20 antibody. Participants must be in good physical condition and not have had recent stem cell transplants, CNS lymphoma, significant heart disease, or active infections.

What is being tested?

The trial is testing the combination of tafasitamab and parsaclisib to see if they're safe together and effective for treating B-cell malignancies. It's a Phase 1b/2a study where all participants receive both drugs at doses previously found to be safe.

What are the potential side effects?

Potential side effects may include reactions related to the immune system like infusion-related symptoms, liver issues due to hepatic toxicity, bone marrow suppression leading to blood disorders, increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is visible on scans.

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My cancer is a specific type of B-cell malignancy.

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My lymphoma or leukemia has returned or is not responding to treatment.

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I have had at least 2 treatments for my condition, including one with an anti-CD20 antibody.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have not had any other cancer in the last 3 years.

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I have a long-term or currently active infection.

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I am experiencing symptoms of graft-versus-host disease.

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I have been treated with CD19-targeted therapy or PI3K inhibitors before.

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I had a stem cell transplant from a donor within the last 6 months or my own within the last 3 months.

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My cancer is a type of lymphoma that affects the brain or spinal cord.

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I haven't taken any cancer treatment or experimental drugs in the last 30 days.

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My condition is a type of lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1b : Incidence of Dose Limiting Toxicities

Phase 1b : Number of Treatment Emergent Adverse Events

Secondary study objectives

Pharmacokinetics Parameter : AUC(t) of tafasitamab

Pharmacokinetics Parameter : Cmax of tafasitamab

Pharmacokinetics Parameter : Cmin of tafasitamab

+3 more

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: tafasitamab + parsaclisibExperimental Treatment2 Interventions

Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

parsaclisib

2021

Completed Phase 2

~120

0 / 14Eligibility criteria met