What side effects are associated with this type of intervention?

Common treatments for Diffuse Large B-Cell Lymphoma (DLBCL) include R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and newer combinations like Tafasitamab plus Lenalidomide. Known side effects of R-CHOP include neutropenia, infection, nausea, hair loss, and cardiotoxicity. Tafasitamab, an anti-CD19 antibody, can cause infusion-related reactions and infections. Lenalidomide, an immunomodulatory drug, is associated with neutropenia, thrombocytopenia, fatigue, and an increased risk of deep vein thrombosis. Combining these therapies may increase the risk of infections and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for Diffuse Large B-Cell Lymphoma (DLBCL) that target CD19 or modulate the immune response. One notable approval is for axicabtagene ciloleucel, a CAR T-cell therapy targeting CD19, which has shown efficacy in relapsed or refractory DLBCL. Additionally, lenalidomide, an immunomodulatory drug, has been used in combination with rituximab (an anti-CD20 monoclonal antibody) for treating DLBCL. These treatments share similarities with the combination of tafasitamab (anti-CD19) and lenalidomide being studied in clinical trials.

What other types of research exist?

Promising novel alternatives for DLBCL treatment in 2024 include: 1) Chimeric Antigen Receptor (CAR) T-cell therapies such as axicabtagene ciloleucel and lisocabtagene maraleucel, which target CD19 on B cells. 2) Bispecific T-cell engagers (BiTEs) like glofitamab and epcoritamab, which also target CD19 and engage T cells to kill cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which targets CD79b on B cells. These therapies have shown promising results in clinical trials and offer novel mechanisms of action compared to Tafasitamab plus Lenalidomide.

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Alkylating agents

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

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

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

Pivotal Trial

Summary

This trial tests a new treatment combining an antibody, an immune-boosting drug, and standard chemotherapy for high-risk patients with newly diagnosed aggressive lymphoma. The goal is to see if this combination works better than standard chemotherapy alone. Rituximab, when combined with standard chemotherapy, has shown significant improvements in response rates and survival for patients with aggressive lymphoma.

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.

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.

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS-INV

Secondary study objectives

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

Pneumonia

Rhinitis

Headache

Paraesthesia

Blood creatinine increased

Hypertension

Sinusitis

Abdominal pain upper

Mucosal inflammation

Gastroenteritis

Gamma-glutamyltransferase increased

Anxiety

Oropharyngeal pain

Arthralgia

Hypotension

Sciatica

Rash maculo-papular

Febrile neutropenia

Dysuria

Blood alkaline phosphatase increased

Hyperglycaemia

Productive cough

Lymphopenia

Hypocalcaemia

Hypogammaglobulinaemia

Infusion related reaction

COVID-19

Pulmonary embolism

Basal cell carcinoma

Lower respiratory tract infection

Squamous cell carcinoma

Atrial fibrillation

Cardiac failure congestive

Transient ischaemic attack

Cholecystitis

Haematoma

Prostate cancer

Enterobacter bacteraemia

Escherichia bacteraemia

Febrile infection

Influenza

Klebsiella sepsis

Bowen's disease

Breast cancer

Lung adenocarcinoma

Myelodysplastic syndrome

Intervertebral discitis

Cardio-respiratory arrest

Bronchopulmonary aspergillosis

Cerebrovascular accident

Cervicobrachial syndrome

Transient global amnesia

Sudden death

COVID-19 pneumonia

Gastroenteritis rotavirus

Myeloproliferative neoplasm

Cytomegalovirus infection

Neutropenic sepsis

Parainfluenzae virus infection

Progressive multifocal leukoencephalopathy

Respiratory syncytial virus infection

Sepsis

Soft tissue infection

Streptococcal sepsis

Urinary tract infection enterococcal

Varicella zoster virus infection

Lower limb fracture

Wound complication

Tumour flare

Biliary colic

Muscular weakness

Agranulocytosis

Cardiac failure

Myocardial ischaemia

Cognitive disorder

Facial paralysis

Chronic obstructive pulmonary disease

Respiratory failure

Arthritis

Osteonecrosis

Pathological fracture

Femur fracture

Renal failure

Deep vein thrombosis

100%

80%

60%

40%

20%

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.

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

~2240

Rituximab

1999

Completed Phase 4

~2990

Cyclophosphamide

2010

Completed Phase 4

~2310

Tafasitamab

2016

Completed Phase 3

~630

Doxorubicin

2012

Completed Phase 3

~8030

Vincristine

2003

Completed Phase 4

~2970

Prednisone

2014

Completed Phase 4

~2500

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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.