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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02763319
Registration number
NCT02763319
Ethics application status
Date submitted
30/04/2016
Date registered
5/05/2016
Date last updated
2/08/2022
Titles & IDs
Public title
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)
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Scientific title
A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)
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Secondary ID [1]
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2014-004689-11
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Secondary ID [2]
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MOR208C204
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Universal Trial Number (UTN)
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Trial acronym
B-MIND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rituximab (RTX)
Treatment: Drugs - Tafasitamab
Treatment: Drugs - Bendamustine (BEN)
Experimental: Tafasitamab and bendamustine - Tafasitamab and bendamustine
Active Comparator: Rituximab and bendamustine - Rituximab and bendamustine
Treatment: Drugs: Rituximab (RTX)
Rituximab: Dose: 375 mg/m2 IV
Treatment: Drugs: Tafasitamab
Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)
Treatment: Drugs: Bendamustine (BEN)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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To determine the efficacy of a combination of MOR00208 with BEN versus a combination of RTX with BEN in terms of progression-free survival (PFS) in:
Adult patients with R-R DLBCL (overall population)
A subgroup of adult patients with R-R DLBCL with low baseline peripheral blood NK-cell count (NKCC-low)
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Timepoint [1]
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From date of randomization until recurrence/disease progression, unacceptable toxicity, death or discontinuation for any other reason, whichever comes first assessed up to 4 yrs
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Secondary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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To determine efficacy
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Timepoint [1]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [2]
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Duration of response (DoR)
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Assessment method [2]
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To determine efficacy
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Timepoint [2]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [3]
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overall survival (OS)
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Assessment method [3]
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To determine efficacy
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Timepoint [3]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [4]
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disease control rate (DCR)
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Assessment method [4]
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To determine efficacy
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Timepoint [4]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [5]
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time to progression (TTP)
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Assessment method [5]
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To determine efficacy
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Timepoint [5]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [6]
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time to next treatment (TTNT)
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Assessment method [6]
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To determine efficacy
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Timepoint [6]
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From date of randomization assessed up to 4 yrs
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Secondary outcome [7]
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Number of patients with adverse events
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Assessment method [7]
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Number of participants with treatment- and non-treatment related adverse events as assessed by CTCAE
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Timepoint [7]
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assessed up to 4 yrs
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Secondary outcome [8]
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quality of life (QoL)
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Assessment method [8]
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EORTC QLQ-C30 and EQ-5D-5L questionnaires will be used
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Timepoint [8]
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assessed up to 4 yrs
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Secondary outcome [9]
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Number of patients developing Tafasitamab antibodies
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Assessment method [9]
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Timepoint [9]
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assessed up to 2 yrs
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Secondary outcome [10]
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Maximum Plasma Concentration of Tafasitamab (Cmax)
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Assessment method [10]
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0
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Timepoint [10]
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assessed up to 2 yrs
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Secondary outcome [11]
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Apparent trough concentration (Cpd) of Tafsitamab
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Assessment method [11]
0
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Timepoint [11]
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assessed up to 2 yrs
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Eligibility
Key inclusion criteria
INCLUSION CRITERIA:
1. Age =18 years
2. 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.
3. Fresh tumour tissue for central pathology review must be provided as an adjunct to
participation in this study. Should it not be possible to obtain a fresh tumour tissue
sample, archival paraffin embedded tumour tissue acquired =3 years prior to screening
for this protocol must be available for this purpose.
4. Patients must have:
1. relapsed or refractory DLBCL
2. at least one bidimensionally measurable disease site. The lesion must have a
greatest transverse diameter of =1.5 cm and greatest perpendicular diameter of
=1.0 cm at baseline. The lesion must be positive on PET scan
3. received at least one, but no more than three previous systemic therapy lines for
the treatment of DLBCL. At least one previous therapy line must have included a
CD20-targeted.
4. ECOG 0 to 2
5. Patients after failure of ASCT or patients considered in the opinion of the
investigator currently not eligible for HDC with subsequent ASCT.
6. Patients must meet the following laboratory criteria at Screening:
1. ANC =1.5 × 109/L (unless secondary to bone marrow involvement by DLBCL)
2. PLTs =90 × 109/L (unless secondary to bone marrow involvement by DLBCL) and
absence of active bleeding
3. total serum bilirubin =2.5 × ULN unless secondary to Gilbert's syndrome (or
pattern consistent with Gilbert's) or documented liver involvement by lymphoma.
Patients with Gilbert's syndrome or documented liver involvement by lymphoma may
be included if their total bilirubin is =5 x ULN
4. ALT, AST and AP =3 × ULN or <5 × ULN in cases of documented liver involvement by
lymphoma
5. serum creatinine =2.0 x ULN or creatinine clearance must be =40 mL/min calculated
using a standard Cockcroft-Gault formula (Cockroft & Gault, 1976)
7. For a female of childbearing potential (FCBP), a negative pregnancy test must be
confirmed before enrolment. An FCBP must commit to take highly effective contraceptive
precautions without interruption during the study and for 3, 6 or 12 months after the
last dose of Tafasitamab, BEN or RTX respectively, whichever is later. An FCBP must
refrain from breastfeeding and donating blood or oocytes during the course of the
study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX
respectively, whichever is later. Restrictions concerning blood donations apply as
well to females who are not of childbearing potential.
8. Males must use an effective barrier method of contraception without interruption
during the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or
RTX respectively, whichever is later, if the patient is sexually active with an FCBP.
Males must refrain from donating blood or sperm during study participation and for 3,
6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever
is later.
9. In the opinion of the investigator, the patients must:
1. be able to comply with all study-related procedures, medication use, and
evaluations
2. be able to understand and give informed consent
3. not be considered to be potentially unreliable and/or not cooperative.
EXCLUSION CRITERIA:
1. Patients who have: any other histological type of lymphoma including, e.g., primary
mediastinal (thymic) large B-cell lymphoma (PMBL) or Burkitt's lymphoma, primary
refractory DLBCL, patients with known "double/triple hit" DLBCL genetics, CNS lymphoma
involvement in present or past medical history
2. Patients who had a major surgery less than 30 days prior to Day 1 dosing
3. Patients who have, within 14 days prior to Day 1 dosing:
1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,
investigational anticancer therapy or other lymphoma-specific therapy
2. received live vaccines
3. required parenteral antimicrobial therapy for active, intercurrent systemic
infections
4. Patients who:
1. in the opinion of the investigator, have not recovered sufficiently from the
adverse toxic effects of prior therapies, major surgeries or significant
traumatic injuries
2. were previously treated with CD19-targeted therapy or BEN
3. have a history of previous severe allergic reactions to compounds of similar
biological or chemical composition to Tafasitamab, RTX, murine proteins or BEN,
or the excipients contained in the study drug formulations
4. have undergone ASCT within a period of =3 months prior to signing the informed
consent form. Patients who have a more distant history of ASCT must exhibit full
haematological recovery before enrolment into the study.
5. have undergone previous allogeneic stem cell transplantation
6. concurrently use other anticancer or experimental treatments
5. Prior history of malignancies other than DLBCL, unless the patient has been free of
the disease for =3 years prior to Screening. Exceptions to the =3-year time limit
include history of the following:
1. basal cell carcinoma of the skin
2. squamous cell carcinoma of the skin
3. carcinoma in situ of the cervix, breast and bladder
f) incidental histological finding of prostate cancer (Tumour/Node/Metastasis [TNM]
stage of T1a or T1b)
6. Patients with:
1. positive hepatitis B and/or C serology
2. known seropositivity for or history of active viral infection with HIV
3. evidence of active, severe uncontrolled systemic infections or sepsis
4. a history or evidence of severely immunocompromised state
5. a history or evidence of severe hepatic impairment (total serum bilirubin > 3
mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver
involvement by lymphoma
6. a history or evidence of clinically significant cardiovascular, cerebrovascular,
CNS and/or other disease that, in the investigator's opinion, would preclude
participation in the study or compromise the patient's ability to give informed
consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
450
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Recruitment in Australia
Recruitment state(s)
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MorphoSys Research Site - Adelaide
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MorphoSys Research Site - Albury
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5000 - Adelaide
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2640 - Albury
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5042 - Bedford Park
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3128 - Box Hill
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2139 - Concord
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3199 - Frankston
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2605 - Garran
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3220 - Geelong
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2250 - Gosford
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6009 - Nedlands
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4101 - South Brisbane
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3021 - St. Albans
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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MorphoSys AG
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ICON Clinical Research
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Summary
Brief summary
The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus
RTX with BEN in adult patients with relapsed of refractory DLBCL.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02763319
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02763319
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