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Immunomodulatory Agent
Lenalidomide for Diffuse Large B-Cell Lymphoma (L-MIND Trial)
Phase 2
Waitlist Available
Led By Johannes Duell, MD
Research Sponsored by MorphoSys AG
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 approximately 2.5 years after first participant enrolled
Awards & highlights
L-MIND Trial Summary
This trial is testing a new antibody combined with Lenalidomide to see if it is safe and effective in treating adults with DLBCL who have had one to three prior systemic treatments and are not eligible for high dose chemotherapy with ASCT.
Eligible Conditions
- Diffuse Large B-Cell Lymphoma
L-MIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2.5 years after first participant enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2.5 years after first participant enrolled
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Best Objective Response Rate (ORR)
Secondary outcome measures
DCR by INV Evaluation
Disease Control Rate (DCR) by IRC Evaluation
DoR by Investigator (INV) Evaluation
+12 moreL-MIND Trial Design
1Treatment groups
Experimental Treatment
Group I: Tafasitamab (MOR00208) + lenalidomide (LEN)Experimental Treatment2 Interventions
MOR00208:
MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.
Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.
LEN:
Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
On days when both study drugs were given together, LEN was administered prior to MOR00208.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Tafasitamab
2016
Completed Phase 2
~180
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Who is running the clinical trial?
MorphoSys AGLead Sponsor
26 Previous Clinical Trials
6,579 Total Patients Enrolled
Anna-Maria Jegg, PhDStudy DirectorGlobal Program Medical Director
Sumeet V Ambarkhane, MDStudy DirectorClinical Program Leader
Frequently Asked Questions
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