CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 66 enrolled
Drug / intervention
Tafasitamab +1 moredrug
Likely dose
Tafasitamab 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04134936
NCT04134936Phase 1Completed
CompareCT.gov

A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND

MorphoSys AG·interventional·Posted Oct 22, 2019·Updated Oct 16, 2024

In Brief

A Phase 1 clinical trial evaluating Tafasitamab and Tafasitamab plus lenalidomide for Diffuse Large B-cell Lymphoma. Completed, enrolled 66 participants across 70 sites in 9 countries.

Detailed Summary

This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-cell Lymphoma
CountriesAustria, Belgium, Czechia, France, Germany, Italy, Portugal, Spain, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 22, 2019
Enrollment StartDec 11, 2019
Primary CompletionFeb 11, 2021
Study CompletionAug 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.7 years ago

Interventions

Tafasitamabdrug

Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP

Tafasitamab plus lenalidomidedrug

Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP