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Anti-metabolites

Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Xencor, Inc.

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 from first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)

Awards & highlights

Study Summary

This trial will study if a combination of drugs is safe and effective in treating people with a certain type of blood cancer that has come back or does not respond to other treatments.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug up to end of treatment (maximum treatment exposure: 303 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to end of treatment (maximum treatment exposure: 303 days) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1 A: Number of Participants With Cytokine Release Syndrome

Part 1 A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 2A :Plamotamab, Tafasitamab, and LenalidomideExperimental Treatment3 Interventions

Drug: Plamotamab will be administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally).

Group II: Part 1B: Plamotamab (target dose), Tafasitamab, and LenalidomideExperimental Treatment3 Interventions

Drug: Plamotamab will be administered at the target dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially after Part 1A.

Group III: Part 1A: Plamotamab (lower dose), Tafasitamab, and LenalidomideExperimental Treatment3 Interventions

Drug: Plamotamab will be administered at a lower dose in addition to tafasitamab (12 milligrams [mg]/kilograms [kg] intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially prior to Part 1B.

Group IV: Part 2B: Tafasitamab and LenalidomideActive Control2 Interventions

Drug: Tafasitamab (12 mg/kg intravenously) plus lenalidomide 25 mg (orally).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Tafasitamab

2016

Completed Phase 2

~180

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,750 Total Patients Enrolled

Steve Kye, MDStudy DirectorExecutive Medical Director, Clinical Development

Michael ChiarellaStudy DirectorSenior Director, Clinical Science, Clinical Development

Frequently Asked Questions

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

What is the federal regulatory status of plamotamab?

"Taking into account the Phase 2 classification, which indicates limited evidence regarding safety but no proof of efficacy, plamotamab is rated at a two on our safety scale."

Answered by AI

Is there an ongoing call for participants right now?

"Affirmative, the information presented on clinicaltrials.gov demonstrates that this research is actively recruiting participants. This trial was posted to their website on June 30th 2022 and has been updated as recently as May 2nd 2021; requiring a total of 240 patients from one site for enrolment in the study."

Answered by AI

How many individuals can participate in this clinical trial?

"Affirmative. Records available through clinicaltrials.gov demonstrate that this research is currently in the process of recruiting participants, with the initial post on June 30th 2022 and last edited May 2nd 2022. Ultimately, 240 individuals are needed to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)

2022. "Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05328102.