Tafasitamab for Lymphoma, B-Cell

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lymphoma, B-Cell+3 More
Tafasitamab - Drug
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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02639910) in the Cohort B (Tafasitamab+Venetoclax) ARM group. Side effects include: Neutropenia with 46%, Hyperuricaemia with 38%, Cough with 38%, Nausea with 38%, Infusion related reaction with 38%.

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 preview

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.