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Anti-metabolites

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

Phase 1 & 2
Recruiting
Research Sponsored by MorphoSys AG
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 - 3 years approximately
Awards & highlights

MINDway Trial Summary

This trial is testing a new way to give the drug Tafasitamab to people with a certain type of lymphoma who have not responded to other treatments.

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.Check my eligibility
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.See study design
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.

MINDway Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had CD19 targeted therapy before and my lymphoma is still CD19 positive.
Select...
I have a tumor visible on PET scan that is at least 1.5 cm by 1.0 cm.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I've had 1-3 treatments for DLBCL, including one targeting CD20.
Select...
I have had 1-3 treatments for my refractory disease, including one targeting CD20.
Select...
My cancer has returned or is not responding to treatment.
Select...
My diagnosis is diffuse large B-cell lymphoma.

MINDway Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 3 years approximately
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 3 years approximately for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine recommended dose
Evaluate safety and tolerability
Secondary outcome measures
Assess anti-tumor activity
Duration of response (DoR)
Evaluate pharmacokinetic profile
+1 more
Other outcome measures
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
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)

MINDway 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 2
~180
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

MorphoSys AGLead Sponsor
26 Previous Clinical Trials
6,609 Total Patients Enrolled

Media Library

Lenalidomide (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05222555 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (Tafasitamab + Lenalidomide)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT05222555 — Phase 1 & 2
Lenalidomide (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222555 — Phase 1 & 2

Frequently Asked Questions

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

Are new patients being accepted into this clinical trial?

"This study is still recruiting patients, as indicated by the clinicaltrials.gov website. This trial was first posted on July 19th, 2020 and updated last September 30th, 2020."

Answered by AI

How can I sign up for the opportunity to participate in this research?

"This particular clinical trial is testing a new medication for patients with lymphoma, aged 18 to 80. Key inclusion criteria that participants must meet are as follows: having received no more than three previous systemic treatments for DLBCL, one of which must have included a CD20-targeted therapy; being in good general health according to the Eastern Cooperative Oncology Group scale; having measurable disease sites; and providing tumor tissue for central pathology review."

Answered by AI

Does this research study allow people who are 35 years or older to participate?

"In order to participate in this particular clinical trial, patients must fall between the ages of 18-80. Out of the 1656 trials for patients over 65 and 308 trials for those under 18, this is one of the few that includes adults in this age bracket."

Answered by AI

How many people can sign up for this clinical trial at most?

"In order for this study to happen, 51 individuals that fit the bill are required. The trial will be conducted by MorphoSys AG at various locations, two of which are Baptist Health in Lexington, Kentucky and Vista Oncology in Olympia, Washington."

Answered by AI

What is the point of this research?

"The objectives of this study, which will take place over the course of 1 to 3 years, are to determine the recommended dosage and evaluate the pharmacokinetic profile. The secondary outcomes include assessing anti-tumor activity and duration of response."

Answered by AI
~15 spots leftby Nov 2024