What side effects are associated with this type of intervention?

Treatments for Non-Hodgkin's Lymphoma, particularly those involving monoclonal antibodies like Tafasitamab and immunomodulatory agents like Lenalidomide, have several known side effects. Monoclonal antibodies can cause infusion-related reactions, neutropenia, and increased risk of infections. Lenalidomide is associated with neutropenia, thrombocytopenia, fatigue, and gastrointestinal symptoms. Both treatments can also increase the risk of secondary malignancies and venous thromboembolism.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma that involve monoclonal antibodies and immunomodulatory agents. Rituximab, a monoclonal antibody targeting CD20, was one of the first such approvals and is commonly used in combination with chemotherapy. More recently, Polatuzumab vedotin, another monoclonal antibody, has been approved for use in combination with bendamustine and rituximab for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Lenalidomide, an immunomodulatory and anti-angiogenic agent, has also been approved for use in combination with rituximab for previously treated follicular lymphoma and marginal zone lymphoma. These treatments share similarities with the trial involving Tafasitamab and Lenalidomide, as they combine monoclonal antibodies with immunomodulatory agents to enhance therapeutic efficacy.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma patients in 2024 include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which have shown significant efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like Blinatumomab, which target CD19 and engage T-cells to kill cancer cells. 3) Antibody-drug conjugates (ADCs) such as Polatuzumab Vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Novel monoclonal antibodies like Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, showing promise in clinical trials.

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Anti-metabolites

Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma (MINDway Trial)

Phase 1 & 2

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

Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy

At least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

Must not have

CNS lymphoma involvement

History of deep venous thrombosis/embolism and not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 - 3 years approximately

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, Tafasitamab and Lenalidomide, given through an infusion. It targets patients with a specific type of lymphoma who have not responded to other treatments and cannot undergo more aggressive therapies. The treatment works by attacking cancer cells and boosting the immune system. Both drugs have shown effectiveness in treating this type of lymphoma.

Who is the study for?

Adults with Diffuse Large B-Cell Lymphoma (DLBCL) who have tried 1-3 treatments but can't have high-dose chemo with stem-cell transplant. They need a confirmed diagnosis, at least one measurable site of cancer, and their major organs must function well. Can't join if they've had certain other cancers, severe diseases, or are HIV positive.

What is being tested?

The trial is testing Tafasitamab combined with Lenalidomide in patients with relapsed or refractory DLBCL. It's an open-label study to see how safe the treatment is and how the body processes it when given in a new dosing regimen.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as infusion reactions, blood disorders like low white cell counts increasing infection risk, liver problems indicated by abnormal tests, and potential for allergic responses if sensitive to similar drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had CD19 targeted therapy before and my lymphoma is still CD19 positive.

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I have a tumor visible on PET scan that is at least 1.5 cm by 1.0 cm.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I've had 1-3 treatments for DLBCL, including one targeting CD20.

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I have had 1-3 treatments for my refractory disease, including one targeting CD20.

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My cancer has returned or is not responding to treatment.

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My diagnosis is diffuse large B-cell lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer affects the central nervous system.

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I have had blood clots and cannot take medication to prevent them during treatment.

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My lymphoma is not the common type.

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I have been treated with IMiDs before.

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I have HIV or have had an active HIV infection.

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My cancer has 'double/triple hit' genetic features.

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I had a stem cell transplant less than 3 months ago.

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I have a rare hereditary sugar intolerance.

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I cannot take pills due to a stomach or intestine problem.

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I have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 - 3 years approximatey

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 - 3 years approximatey

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 3 years approximatey for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine recommended dose

Evaluate safety and tolerability

Secondary study objectives

Assess anti-tumor activity

Duration of response (DoR)

Evaluate pharmacokinetic profile

+1 more

Other study objectives

B cell numbers

NK cell numbers

T cell numbers

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

Intervertebral discitis

Enterobacter bacteraemia

Febrile infection

Cholecystitis

Klebsiella sepsis

Influenza

Prostate cancer

Escherichia bacteraemia

Transient ischaemic attack

Cardio-respiratory arrest

Haematoma

Myelodysplastic syndrome

Breast cancer

Lung adenocarcinoma

Bowen's disease

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Tafasitamab + Lenalidomide)Experimental Treatment2 Interventions

Treatment: Tafasitamab will be combined with lenalidomide in R/R DLBCL patients. Dose: Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 \& cohort 2 Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tafasitamab

2016

Completed Phase 3

~630

Lenalidomide

2005

Completed Phase 3

~2240

0 / 18Eligibility criteria met

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

Monoclonal antibodies, such as tafasitamab, target specific antigens like CD19 on lymphoma cells, leading to their destruction either directly or by marking them for immune system attack. Lenalidomide, an immunomodulatory and anti-angiogenic agent, boosts the immune response against lymphoma cells and inhibits the formation of new blood vessels that tumors require for growth. These mechanisms are significant for Non-Hodgkin's Lymphoma patients as they offer targeted treatment options that can be more effective and potentially less toxic than traditional chemotherapy.

Optimizing First-Line Therapy for Follicular Lymphoma: Is It Time for Chemotherapy-Free Approaches?