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Alkylating agents

Tafasitamab + Bendamustine vs Rituximab + Bendamustine for Lymphoma (B-MIND Trial)

Phase 2 & 3
Waitlist Available
Led By Grzegorz Nowakowski, MD
Research Sponsored by MorphoSys AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- serum creatinine ≤2.0 x ULN or creatinine clearance must be ≥40 mL/min calculated using a standard Cockcroft-Gault formula (Cockroft & Gault, 1976)
Histologically confirmed diagnosis, according to the World Health Organization (WHO, 2008) classification, of: DLBCL NOS, THRLBCL, EBV-positive DLBCL, composite lymphoma with a DLBCL component with a DLBCL relapse subsequent to DLBCL treatment, disease transformed from an earlier diagnosis of low grade lymphoma (i.e. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with a DLBCL relapse subsequent to DLBCL treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 4 yrs
Awards & highlights

B-MIND Trial Summary

This trial will compare two different treatments for adult patients with a certain kind of blood cancer that has come back or didn't respond to initial treatment.

Who is the study for?
Adults with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) who have tried up to three treatments, including one with CD20-targeted therapy. They must be over 18, in fairly good health (ECOG 0-2), and not planning on pregnancy or donating blood/sperm for a while after the trial.Check my eligibility
What is being tested?
The trial is testing Tafasitamab combined with Bendamustine against Rituximab with Bendamustine to see which is safer and more effective for treating DLBCL in adults who haven't responded well to previous treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, low blood counts leading to increased infection risk, fatigue, liver issues, and potential allergic reactions. The severity of side effects can vary from person to person.

B-MIND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
My diagnosis is a specific type of lymphoma as defined by WHO.
Select...
My DLBCL cancer has returned or is not responding to treatment.
Select...
My platelet count is above 90, and I'm not currently bleeding.
Select...
I have a tumor that is visible and measurable on scans.
Select...
I have had 1-3 treatments for DLBCL, including one targeting CD20.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.

B-MIND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 4 yrs
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 4 yrs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Apparent trough concentration (Cpd) of Tafsitamab
Duration of response (DoR)
Maximum Plasma Concentration of Tafasitamab (Cmax)
+8 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%
Sinusitis
7%
Abdominal pain upper
7%
Mucosal inflammation
7%
Gastroenteritis
7%
Gamma-glutamyltransferase increased
7%
Anxiety
7%
Oropharyngeal pain
7%
Arthralgia
7%
Hypotension
6%
Febrile neutropenia
6%
Productive cough
6%
Blood alkaline phosphatase increased
6%
Hyperglycaemia
6%
Dysuria
6%
Sciatica
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%
Cardio-respiratory arrest
1%
Lung adenocarcinoma
1%
Bowen's disease
1%
Gastroenteritis rotavirus
1%
Myelodysplastic syndrome
1%
Febrile infection
1%
Influenza
1%
Cerebrovascular accident
1%
Cervicobrachial syndrome
1%
Cholecystitis
1%
Haematoma
1%
Bronchopulmonary aspergillosis
1%
Transient ischaemic attack
1%
Escherichia bacteraemia
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)

B-MIND Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tafasitamab and bendamustineExperimental Treatment2 Interventions
Tafasitamab and bendamustine
Group II: Rituximab and bendamustineActive Control2 Interventions
Rituximab and bendamustine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tafasitamab
2016
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
14,922 Total Patients Enrolled
MorphoSys AGLead Sponsor
26 Previous Clinical Trials
6,210 Total Patients Enrolled
Grzegorz Nowakowski, MDPrincipal InvestigatorMayo Clinic

Media Library

Bendamustine (BEN) (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02763319 — Phase 2 & 3
Diffuse Large B-Cell Lymphoma Research Study Groups: Tafasitamab and bendamustine, Rituximab and bendamustine
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Bendamustine (BEN) Highlights & Side Effects. Trial Name: NCT02763319 — Phase 2 & 3
Bendamustine (BEN) (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02763319 — Phase 2 & 3

Frequently Asked Questions

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

Are there other ongoing research trials that are testing Tafasitamab?

"Tafasitamab was first researched in 1993 at the National Institutes of Health Clinical Center. There have been 875 completed trials and presently 466 studies are actively recruiting. A majority of these trials are based in Los Angeles, California."

Answered by AI

Is this clinical trial being run in more than one location within the city?

"Presently, this clinical trial is actively recruiting patients from 26 different sites. While some of these sites are in Los Angeles, Jackson and Plainville, there are also other locations that are participating. If you enroll, try to select the site that is closest to your location to reduce travel burden."

Answered by AI

Are new patients currently being accepted for this clinical trial?

"This research is no longer active. The trial was first posted on June 1st, 2016 and was last edited on August 1st, 2022. However, there are other opportunities available; 1797 trials are currently recruiting patients with lymphoma and 466 studies are looking for participants for Tafasitamab."

Answered by AI

What are the most common medical conditions that Tafasitamab is indicated for?

"Tafasitamab is an effective therapeutic intervention for patients with diffuse large b-cell lymphoma (DLBCL) and Hodgkin disease."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
2016. "A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02763319.
~5 spots leftby Jun 2024
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