NCT04824092|Active Not RecruitingPhase 3DMCFDA Drug

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Incyte Corporation ClinicalTrials.gov

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3 other identifiers

MOR208C3102022-500237-92-002020-002990-84

Study Type

interventional

Target

899

Locations

28 countries

Sites

300

Timeline

RegisteredApr 2021

StartedMay 2021

CompletionNov 2027

Brief Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

899

participants targeted

Target at P75+ for phase_3

Timeline

18mo left

Started May 2021

Longer than P75 for phase_3

Geographic Reach

28 countries

300 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

Study Progress77%

May 2021Nov 2027

First Submitted

Initial submission to the registry

March 22, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

March 22, 2021

Last Update Submit

March 27, 2026

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCLCD19monoclonal antibodytafasitamablenalidomideR-CHOPDiffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

PFS-INV
Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)

Secondary Outcomes (10)

EFS-INV
From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)
OS
From randomization until the date of death from any cause (up to 62 months)
Metabolic PET-negative CR-rate at EOT by BIRC
End of treatment, 4-8 weeks after last dose
Metabolic PET-negative CR-rate at EOT by INV
End of treatment, 4-8 weeks after last dose
ORR as per INV at EOT
6 ± 2 weeks after End of Treatment
+5 more secondary outcomes

Study Arms (2)

Tafasitamab plus lenalidomide in addition to R-CHOP

EXPERIMENTAL

Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle

Drug: TafasitamabDrug: LenalidomideDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: Prednisone

Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP

PLACEBO COMPARATOR

Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle Lenalidomide placebo: Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle

Drug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: Tafasitamab placeboDrug: Lenalidomide placebo

Interventions

LenalidomideDRUG

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

Tafasitamab plus lenalidomide in addition to R-CHOP

RituximabDRUG

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.