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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the date of death from any cause (up to 62 months)
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the date of death from any cause (up to 62 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the date of death from any cause (up to 62 months)
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 moreSide effects data
From 2023 Phase 2 trial • 81 Patients • NCT0239908564%
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%
Sinusitis
7%
Abdominal pain upper
7%
Mucosal inflammation
7%
Gastroenteritis
7%
Gamma-glutamyltransferase increased
7%
Anxiety
7%
Oropharyngeal pain
7%
Arthralgia
7%
Hypotension
6%
Hyperglycaemia
6%
Blood alkaline phosphatase increased
6%
Febrile neutropenia
6%
Dysuria
6%
Sciatica
6%
Productive cough
6%
Rash maculo-papular
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%
Escherichia bacteraemia
1%
Cardio-respiratory arrest
1%
Bronchopulmonary aspergillosis
1%
Cervicobrachial syndrome
1%
Febrile infection
1%
Influenza
1%
Cerebrovascular accident
1%
Bowen's disease
1%
Transient ischaemic attack
1%
Cholecystitis
1%
Haematoma
1%
Myelodysplastic syndrome
1%
Gastroenteritis rotavirus
1%
Lung adenocarcinoma
1%
Transient global amnesia
1%
Sudden death
1%
Breast cancer
1%
Myeloproliferative neoplasm
1%
COVID-19 pneumonia
1%
Klebsiella sepsis
1%
Enterobacter bacteraemia
1%
Intervertebral discitis
1%
Prostate cancer
1%
Cytomegalovirus infection
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%
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%
Femur fracture
1%
Renal failure
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (MOR00208, Lenalidomide)
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
~1340
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~2200
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Tafasitamab
2016
Completed Phase 2
~180
Vincristine
2003
Completed Phase 4
~2910
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Tafasitamab is a monoclonal antibody that targets CD19 on B cells, leading to their destruction through immune-mediated mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis. Lenalidomide modulates the immune response by enhancing T-cell and natural killer (NK) cell function, and inhibiting angiogenesis and cytokine release.
These mechanisms are crucial for DLBCL patients as they directly target malignant B cells and enhance the body's immune response to fight the cancer, potentially leading to better treatment outcomes.
Find a Location
Who is running the clinical trial?
MorphoSys AGLead Sponsor
26 Previous Clinical Trials
5,763 Total Patients Enrolled
Andrea Sporchia, MDStudy DirectorMorphoSys AG
Associate Director, Clinical DevelopmentStudy DirectorMorphoSys AG
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma type is not specifically listed.My cancer has spread to my brain.I am considered a suitable candidate for R-CHOP treatment.I can take care of myself and perform daily activities.I have received treatments for lymphoma before the start of this clinical trial.I have had cancer before, but it wasn't related to blood.My lymphoma is CD20-positive and has not been treated yet.I do not have any major heart, brain, or systemic diseases that could affect my participation.I am allergic or cannot tolerate the drugs in R-CHOP.I currently have an active infection.My lymphoma diagnosis matches the 2016 WHO classification.I can provide samples of my tumor for testing.My blood counts are within a healthy range.My cancer severity score fits the trial's requirements.I agree to use condoms and not donate sperm.
Research Study Groups:
This trial has the following groups:- Group 1: Tafasitamab plus lenalidomide in addition to R-CHOP
- Group 2: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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