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PI3K Inhibitor

parsaclisib for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

topMIND Trial 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.Check my eligibility

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.See study design

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.

topMIND Trial 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.

topMIND Trial 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

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

Primary outcome measures

Phase 1b : Incidence of Dose Limiting Toxicities

Phase 1b : Number of Treatment Emergent Adverse Events

Secondary outcome measures

Pharmacokinetics Parameter : AUC(t) of tafasitamab

Pharmacokinetics Parameter : Cmax of tafasitamab

Pharmacokinetics Parameter : Cmin of tafasitamab

+3 more

topMIND 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,111 Total Patients Enrolled

Oliver Manzke, MDStudy DirectorIncyte Corporation

2 Previous Clinical Trials

111 Total Patients Enrolled

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04809467 — Phase 1 & 2

Chronic Lymphocytic Leukemia Research Study Groups: tafasitamab + parsaclisib

Chronic Lymphocytic Leukemia Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT04809467 — Phase 1 & 2

Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809467 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple health care facilities trialing this experiment in the city?

"Eight medical sites have begun enrolling patients, such as Clinical Research Alliance in New Hyde Park, Jefferson University Hospitals in Philadelphia and Indiana Blood and Marrow Transplantation in Los Angeles. Additionally, there are five other healthcare centres participating."

Answered by AI

Are there any current opportunities to join this clinical experiment?

"As of this moment, no further patients are being sought for the trial originally posted on September 16th 2021. However, if you're looking to join other medical trials pertaining to non-Hodgkin's lymphoma (NHL) there are 2,897 studies available and 26 studies involving tafasitamab that still have spots open."

Answered by AI

What is the current tally of participants in this trial?

"At the present moment, this clinical trial is not seeking to enrol new patients. The initial posting was on September 16th 2021 and the most recent update occurred one year later. If you are considering alternative studies, there are 2897 trials for non-Hodgkin's lymphoma (NHL) that require participants as well as 26 investigations involving tafasitamab currently recruiting individuals."

Answered by AI

What are the primary goals of this medical experiment?

"The primary assessment of this clinical trial, which will span up to 25 months, is the incidence of Dose Limiting Toxicities. Further secondary evaluations include AUC(t) and Tmax measurements for tafasitamab as well as an Overall Response Rate based on the Lugano criteria and iwCLL standards."

Answered by AI

Does this trial introduce any new procedures or treatments?

"Presently, MorphoSys AG's tafasitamab is being tested in 26 trials across 42 nations and 224 cities. The drug prototype underwent Phase 2 approval after its initial trial in 2014 with 41 participants; since then, 13 other studies have been completed."

Answered by AI

What other research projects have utilized tafasitamab as an independent variable?

"At present, there are 26 ongoing trials investigating the effects of tafasitamab. Of those studies, 6 have reached Phase 3. Although Rozzano is a primary site for these clinical trials, there are 1914 different medical centres conducting research related to this treatment worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

2021. "A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04809467.

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