Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Lymphoma, B-Cell
- Diffuse Large B-cell Lymphoma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: From randomization until the date of death from any cause (up to 62 months)
36 months after randomization
EFS at 3 years
OS at 3 years
PFS at 3 years
Week 2
MRD status at EOT
ORR as per INV at EOT
Week 8
Metabolic PET-negative CR-rate at EOT by BIRC
Metabolic PET-negative CR-rate at EOT by INV
Month 43
PFS-INV
Month 62
OS
Month 43
EFS-INV
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Cohort B (Tafasitamab+Venetoclax)
46%Neutropenia
38%Hyperuricaemia
38%Cough
38%Nausea
38%Infusion related reaction
31%Hypophosphataemia
31%Blood lactate dehydrogenase increased
23%Pyrexia
23%Fatigue
23%Troponin T increased
23%Hypokalaemia
23%Dyspnoea
23%Iron deficiency
23%Leukopenia
23%Hypocalcaemia
23%Vomiting
23%Dyspepsia
15%Anaemia
15%Upper respiratory tract infection
15%Brain natriuretic peptide increased
15%Weight decreased
15%Hyperglycaemia
15%Coombs test positive
15%Myalgia
15%Muscle spasms
15%Insomnia
15%Arthralgia
15%Tachycardia
15%Diarrhoea
15%Pneumonia
15%Respiratory tract infection
15%Dizziness
8%Orthostatic hypotension
8%Small airways disease
8%Deep vein thrombosis
8%Alopecia
8%Peripheral venous disease
8%Pruritus
8%Weight increased
8%Pulmonary embolism
8%Atrioventricular block second degree
8%Anal haemorrhage
8%Cholelithiasis
8%Groin pain
8%Helicobacter gastritis
8%Rhinovirus infection
8%Lymphopenia
8%Face oedema
8%Pneumococcal sepsis
8%Chest discomfort
8%Constipation
8%Nasopharyngitis
8%Sinusitis
8%Inguinal hernia
8%Immunodeficiency
8%C-reactive protein increased
8%Hepatic enzyme increased
8%Rhinitis
8%Exostosis
8%Joint swelling
8%Blood alkaline phosphatase increased
8%Lethargy
8%Rhinitis allergic
8%Hyperhidrosis
8%Onychoclasis
8%Burning sensation
8%Pleural effusion
8%Skin lesion
8%Electrocardiogram T wave abnormal
8%Paronychia
8%Tendon rupture
8%Sinus disorder
8%Haematochezia
8%Infectious pleural effusion
8%Depressed mood
8%Lymphadenopathy
8%Drug intolerance
8%Hepatic cyst
8%Musculoskeletal pain
8%Hyperbilirubinaemia
8%Rash
8%Increased bronchial secretion
8%Thrombocytopenia
8%Alanine aminotransferase increased
8%Depression
8%Hypertension
8%Atelectasis
8%Pneumothorax
8%Malaise
8%Skin haemorrhage
8%Staphylococcal infection
8%Hypoalbuminaemia
8%Hyperkalaemia
8%Neuropathy peripheral
8%Haematuria
8%Haemothorax
8%Decreased appetite
8%Hypermagnesaemia
8%Dry skin
8%Bone pain
8%Catheter site inflammation
8%Osteosclerosis
8%Atrioventricular block
8%Oral pain
8%Chills
8%Hypomagnesaemia
8%Influenza
8%Tumour lysis syndrome
8%Splenic infarction
8%Palpitations
8%Ear discomfort
8%Deafness unilateral
8%Dry mouth
8%Abdominal pain
8%Umbilical hernia
8%Oedema peripheral
8%Urinary tract infection
8%Abdominal distension
8%Contrast media allergy
8%Graft versus host disease in liver
8%Drug hypersensitivity
8%Hypersensitivity
8%Lung infection
8%Gamma-glutamyltransferase increased
8%Erysipelas
8%Aspartate aminotransferase increased
8%Agitation
8%Arthropod bite
8%Hypoaesthesia
8%Pain in extremity
8%Hypercalcaemia
8%Headache
8%Hypotension
8%Flushing
Trial Design
2 Treatment Groups
Tafasitamab plus lenalidomide in addition to R-CHOP
1 of 2
Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP
1 of 2
Experimental Treatment
Non-Treatment Group
880 Total Participants · 2 Treatment Groups
Primary Treatment: Tafasitamab · Has Placebo Group · Phase 3
Tafasitamab plus lenalidomide in addition to R-CHOPExperimental Group · 7 Interventions: Rituximab, Lenalidomide, Doxorubicin, Prednisone, Cyclophosphamide, Tafasitamab, Vincristine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOPPlaceboComparator Group · 7 Interventions: Rituximab, Doxorubicin, Prednisone, Lenalidomide placebo, Cyclophosphamide, Vincristine, Tafasitamab placebo · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Lenalidomide
FDA approved
Doxorubicin
FDA approved
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Tafasitamab
FDA approved
Vincristine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization until the date of death from any cause (up to 62 months)
Who is running the clinical trial?
MorphoSys AGLead Sponsor
23 Previous Clinical Trials
6,559 Total Patients Enrolled
7 Trials studying Lymphoma, B-Cell
4,775 Patients Enrolled for Lymphoma, B-Cell
Andrea Sporchia, MDStudy DirectorMorphoSys AG
Associate Director, Clinical DevelopmentStudy DirectorMorphoSys AG
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:A tissue sample must be available for review.
You have an IPI status of 3 to 5 or aaIPI 2 to 3.
You have a T-cell rich large B-cell lymphoma.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 21st, 2021
Last Reviewed: November 6th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
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