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Alkylating agents

Tafasitamab + Lenalidomide for Diffuse Large B-Cell Lymphoma (frontMIND Trial)

Phase 3
Waitlist Available
Research Sponsored by MorphoSys AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:
DLBCL, NOS including GCB type, ABC type
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the date of death from any cause (up to 62 months)
Awards & highlights
Pivotal Trial

frontMIND Trial Summary

This trial is testing a new antibody to treat DLBCL, a type of blood cancer. The trial will compare the new treatment to the standard of care to see if it is more effective with fewer side effects.

Who is the study for?
This trial is for adults with untreated CD20-positive DLBCL, a type of lymphoma. They must be suitable for R-CHOP therapy and have an ECOG performance status of 0-2, meaning they are fully active or at least ambulatory. Participants need proper heart function and agree to contraception if applicable. Those with certain other cancers, CNS involvement by lymphoma, significant health issues, infections like TB, or prior anti-lymphoma treatment aren't eligible.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of adding tafasitamab plus lenalidomide to the standard R-CHOP regimen against R-CHOP alone in high-risk DLBCL patients. It's a phase 3 trial where participants are randomly assigned to either receive the new combination or placebo alongside their regular chemotherapy.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as infusion-related symptoms (fever, chills), blood cell count changes leading to increased infection risk or bleeding problems, fatigue from treatment burden on the body's resources, organ-specific inflammation due to immune response misdirection.

frontMIND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of lymphoma that has not been treated yet.
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My diagnosis is diffuse large B-cell lymphoma.
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My diagnosis is T-cell rich large B-cell lymphoma.
Select...
My lymphoma is Epstein-Barr virus positive.
Select...
My cancer is ALK-positive large B-cell lymphoma.
Select...
My lymphoma is HHV8-positive.
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I have high-grade lymphoma with specific genetic changes and am a candidate for R-CHOP treatment.
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My diagnosis is High-Grade B-Cell Lymphoma, not otherwise specified.
Select...
I have DLBCL with either follicular lymphoma, gastric MALT lymphoma, or non-gastric MALT lymphoma.
Select...
My condition is diagnosed as Follicular Lymphoma grade 3b.
Select...
My cancer severity score fits the trial's requirements based on my age.
Select...
My treatment for DLBCL started within 28 days of diagnosis.
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I can take care of myself and perform daily activities.
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My blood counts are within a healthy range.
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I agree to avoid pregnancy, breast feeding, and egg donation, and to undergo regular pregnancy tests during and after the study.
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I agree to not have sex or will use a condom and not donate sperm.

frontMIND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the date of death from any cause (up to 62 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the date of death from any cause (up to 62 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PFS-INV
Secondary outcome measures
Duration of Complete Response (CR) as assessed by the investigator
EFS at 3 years
EFS-INV
+7 more

Side effects data

From 2023 Phase 2 trial • 81 Patients • NCT02399085
64%
Any TEAE
49%
Neutropenia
37%
Diarrhoea
37%
Anaemia
30%
Cough
28%
Thrombocytopenia
26%
Asthenia
25%
Oedema peripheral
22%
Pyrexia
22%
Decreased appetite
20%
Back pain
19%
Hypokalaemia
19%
Constipation
16%
Fatigue
15%
Vomiting
15%
Bronchitis
15%
Muscle spasms
15%
Nausea
12%
Leukopenia
12%
Urinary tract infection
12%
Dyspnoea
11%
Respiratory tract infection
11%
C-reactive protein increased
10%
Abdominal pain
10%
Nasopharyngitis
10%
Upper respiratory tract infection
10%
Pruritus
10%
Rash
10%
Pain in extremity
10%
Hypomagnesaemia
9%
Rhinitis
9%
Pneumonia
9%
Headache
9%
Paraesthesia
9%
Blood creatinine increased
9%
Hypertension
7%
Abdominal pain upper
7%
Sinusitis
7%
Mucosal inflammation
7%
Gastroenteritis
7%
Gamma-glutamyltransferase increased
7%
Anxiety
7%
Oropharyngeal pain
7%
Arthralgia
7%
Hypotension
6%
Dysuria
6%
Sciatica
6%
Productive cough
6%
Blood alkaline phosphatase increased
6%
Rash maculo-papular
6%
Hyperglycaemia
6%
Febrile neutropenia
6%
Lymphopenia
6%
Hypocalcaemia
6%
Hypogammaglobulinaemia
6%
Infusion related reaction
4%
COVID-19
4%
Pulmonary embolism
2%
Basal cell carcinoma
2%
Lower respiratory tract infection
2%
Squamous cell carcinoma
2%
Atrial fibrillation
2%
Cardiac failure congestive
1%
Lung adenocarcinoma
1%
Haematoma
1%
Breast cancer
1%
Prostate cancer
1%
Transient ischaemic attack
1%
Intervertebral discitis
1%
Cholecystitis
1%
COVID-19 pneumonia
1%
Myelodysplastic syndrome
1%
Gastroenteritis rotavirus
1%
Bronchopulmonary aspergillosis
1%
Bowen's disease
1%
Myeloproliferative neoplasm
1%
Cardio-respiratory arrest
1%
Cytomegalovirus infection
1%
Enterobacter bacteraemia
1%
Escherichia bacteraemia
1%
Febrile infection
1%
Influenza
1%
Klebsiella sepsis
1%
Neutropenic sepsis
1%
Parainfluenzae virus infection
1%
Progressive multifocal leukoencephalopathy
1%
Respiratory syncytial virus infection
1%
Sepsis
1%
Soft tissue infection
1%
Streptococcal sepsis
1%
Urinary tract infection enterococcal
1%
Varicella zoster virus infection
1%
Cerebrovascular accident
1%
Cervicobrachial syndrome
1%
Transient global amnesia
1%
Lower limb fracture
1%
Wound complication
1%
Tumour flare
1%
Biliary colic
1%
Muscular weakness
1%
Agranulocytosis
1%
Cardiac failure
1%
Myocardial ischaemia
1%
Cognitive disorder
1%
Facial paralysis
1%
Chronic obstructive pulmonary disease
1%
Respiratory failure
1%
Arthritis
1%
Osteonecrosis
1%
Pathological fracture
1%
Sudden death
1%
Femur fracture
1%
Renal failure
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (MOR00208, Lenalidomide)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

frontMIND Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tafasitamab plus lenalidomide in addition to R-CHOPExperimental Treatment7 Interventions
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
Group II: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOPPlacebo Group7 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3780
Tafasitamab
2016
Completed Phase 2
~180
Vincristine
2003
Completed Phase 4
~2920

Find a Location

Who is running the clinical trial?

MorphoSys AGLead Sponsor
26 Previous Clinical Trials
5,761 Total Patients Enrolled
Andrea Sporchia, MDStudy DirectorMorphoSys AG
Associate Director, Clinical DevelopmentStudy DirectorMorphoSys AG

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04824092 — Phase 3
Diffuse Large B-Cell Lymphoma Research Study Groups: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04824092 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04824092 — Phase 3

Frequently Asked Questions

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

Which patients are eligible for this clinical trial?

"This clinical trial is looking for 880 individuals that have b-cell lymphoma and are aged between 18 and 80. Furthermore, potential participants must meet the following conditions: IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age), DLBCL, NOS including GCB type, ABC type, High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma"

Answered by AI

What indications does Tafasitamab typically address?

"Tafasitamab is most often used as a leukemia treatment, but it can also be taken for other issues such as ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and lung cancers."

Answered by AI

Does this medical experiment have an age limit?

"This trial is currently enrolling individuals who are over the age of 18 and below 80 years old."

Answered by AI

Are patients currently being enrolled in this research program?

"As of 8/23/2022, this study is still open and actively recruiting patients according to the listing on clinicaltrials.gov. This particular trial was first posted on 5/11/21."

Answered by AI

Does Tafasitamab have the green light from the FDA?

"There is some efficacy data from earlier phases as well as multiple rounds of safety testing, so Tafasitamab gets a 3 for safety."

Answered by AI

Could you share the aggregate patient number for this clinical trial?

"That is accurate. The information available on clinicaltrials.gov reveals that this study, which was originally posted on May 11th 2021, is still recruiting patients. 880 individuals are needed for the trial and 100 different sites are being utilized."

Answered by AI

In how many different medical clinics is this trial being offered?

"One hundred different medical facilities are conducting this trial. If you wish to enroll and minimize the burden of travel, pick a location nearest to where you live from the following cities: Fort Worth, Charlotte, Sioux Falls or any of the other 100 locations."

Answered by AI

Are there other examples of Tafasitamab's efficacy?

"Tafasitamab's first clinical trial took place in 1993 at the National Institutes of Health Clinical Center. As of now, a total of 2685 trials have been completed with 1669 still active. A considerable amount of these ongoing studies are based out of Fort Worth, Texas."

Answered by AI
~281 spots leftby Jun 2025