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Maplirpacept + Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the first documentation of a cr until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Awards & highlights
Study Summary
This trial is testing 3 medicines to treat relapsed/refractory DLBCL, a type of NHL cancer, to see if they're safe & effective. Participants will receive them through IV infusion & taking a pill.
Who is the study for?
This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has either come back or didn't respond to treatment. They should have tried at least one other therapy but can't or don't want to do certain stem cell transplants or CAR-T therapy. Participants need to provide a tumor sample and have good enough bone marrow, liver, and kidney function.Check my eligibility
What is being tested?
The study tests the combined effect of three drugs: Maplirpacept (PF-07901801), Tafasitamab, and Lenalidomide in patients with relapsed/refractory DLBCL. Treatments are given in cycles; Maplirpacept by IV infusion weekly then biweekly, Tafasitamab IV on specific days early then biweekly, and daily oral Lenalidomide for part of each cycle.See study design
What are the potential side effects?
Potential side effects include reactions related to intravenous infusions such as discomfort or infection at the injection site, allergic reactions during infusion, fatigue from treatment regimens, digestive issues like nausea or diarrhea from oral medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the first documentation of a cr until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the first documentation of a cr until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Dose limiting toxicity (DLT) rate
Phase 2: Objective Response Rate (ORR)
Secondary outcome measures
Phase 1b and Phase 2: Complete Response Rate (CRR)
Phase 1b and Phase 2: Duration of Complete Response (DoCR)
Phase 1b and Phase 2: Duration of Response (DoR)
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment3 Interventions
Participants will be randomized to 1 of 2 different dose levels of maplirpacept (PF-07901801) which will be administered in combination with standard doses of tafasitamab and lenalidomide. Approximately 50 participants will be enrolled (25 per dose).
Group II: Phase 1bExperimental Treatment3 Interventions
Participants will be allocated to sequential dose levels of maplirpacept (PF-07901801), administered in combination with standard doses of tafasitamab and lenalidomide, to select two doses for further evaluation in Phase 2. Approximately 20 participants will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tafasitamab
2016
Completed Phase 2
~180
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,225 Total Patients Enrolled
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,932 Total Patients Enrolled
MorphoSys AGIndustry Sponsor
26 Previous Clinical Trials
6,590 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing serious infections.I can provide a sample of my tumor for testing before treatment starts.I had a stem cell transplant less than 12 weeks ago.My diagnosis is diffuse large B-cell lymphoma.My liver, kidneys, and bone marrow are working well.I've had 1-2 treatments for my condition, including one with an anti-CD20 antibody.I can perform all self-care but may not be able to work.My condition has returned or didn't respond to treatment.I cannot or do not want to undergo high dose chemotherapy and stem cell transplant, and I cannot receive CAR T-cell therapy.I have previously been treated with anti-CD47, anti-CD19 (not CAR T), or immunomodulatory agents.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b
- Group 2: Phase 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Phase 1b of this therapy received authorization from the US Food and Drug Administration?
"With the absence of efficacy data, our team has ranked the safety of Phase 1b as a 2 on a 3-point scale."
Answered by AI
Are there any available openings for this research endeavor?
"According to the information provided on clinicaltrials.gov, this trial has been actively accepting participants since its inception date of May 23rd 2023 and was last amended on May 17th 2023."
Answered by AI
To what degree is this trial seeing participation from potential test subjects?
"To complete the experiment, 70 eligible participants must be enrolled. Pfizer is managing the trial from two centres: Mary Bird Perkins Cancer Center Baton Rouge in Baton Rouge and Thompson Cancer Survival Center located in Knoxville."
Answered by AI
What is the scope of this study's presence within our state?
"Nine enrolled sites are currently recruiting for this trial, including the Mary Bird Perkins Cancer Center Baton Rouge in Louisiana, Thompson Cancer Survival Center of Knoxville and its Lenoir City counterpart. There is also a number of other medical facilities that meet these criteria."
Answered by AI
What outcomes is this clinical trial intended to realize?
"This clinical trial runs for up to 24 months with the primary outcome being an objective response, while secondary outcomes include an objective response rate (ORR), complete response rate (CRR) and duration of complete response (DoCR). All responses are evaluated against Lugano Response Classification Criteria 2014."
Answered by AI
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