Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04697160




Registration number
NCT04697160
Ethics application status
Date submitted
23/12/2020
Date registered
6/01/2021
Date last updated
20/10/2021

Titles & IDs
Public title
Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL
Scientific title
An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study
Secondary ID [1] 0 0
MOR208C213
Universal Trial Number (UTN)
Trial acronym
RE-MIND2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who received systemic therapies for R/R DLBCL -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
Overall/Objective Response Rate (ORR)
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
Complete Response Rate (CR)
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
through study completion, an average of 1 year
Secondary outcome [4] 0 0
Event Free Survival (EFS)
Timepoint [4] 0 0
through study completion, an average of 1 year
Secondary outcome [5] 0 0
Progression Free Survival (PFS)
Timepoint [5] 0 0
through study completion, an average of 1 year
Secondary outcome [6] 0 0
Time to next treatment (TTNT)
Timepoint [6] 0 0
through study completion, an average of 1 year
Secondary outcome [7] 0 0
Treatment discontinuation rate due to adverse events
Timepoint [7] 0 0
through study completion, an average of 1 year
Secondary outcome [8] 0 0
Duration of treatment exposure
Timepoint [8] 0 0
through study completion, an average of 1 year

Eligibility
Key inclusion criteria
Eligibility Criteria:

1. Age = 18 years at the initial DLBCL diagnosis.
2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.

Non-Eligibility Criteria:

1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
3. Patients who underwent an allogeneic stem cell transplant.
4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for =5 years prior to inclusion.

Note: Patients with the following malignancies within the 5 years period are still eligible:
1. basal cell carcinoma of the skin
2. squamous cell carcinoma of the skin
3. carcinoma in situ of the cervix
4. carcinoma in situ of the breast
5. carcinoma in situ of the bladder
6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b)
5. Patients who received tafasitamab.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2021
Sample size
Target
Accrual to date
Final
3573
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
MorphoSys Research Site - Adelaide
Recruitment hospital [2] 0 0
MorphoSys Research Site - Benowa
Recruitment hospital [3] 0 0
MorphoSys Research Site - Concord
Recruitment hospital [4] 0 0
MorphoSys Research Site - Darlinghurst
Recruitment hospital [5] 0 0
MorphoSys Research Site - East Melbourne
Recruitment hospital [6] 0 0
MorphoSys Research Site - Fitzroy
Recruitment hospital [7] 0 0
MorphoSys Research Site - Frankston
Recruitment hospital [8] 0 0
MorphoSys Research Site - Kingswood
Recruitment hospital [9] 0 0
MorphoSys Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3099 - Frankston
Recruitment postcode(s) [8] 0 0
2747 - Kingswood
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
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United States of America
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Mississippi
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Oregon
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United States of America
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Tennessee
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United States of America
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Utah
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United States of America
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Washington
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Austria
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Leoben
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Austria
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Linz
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Austria
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Salzburg
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Austria
State/province [20] 0 0
Sankt Pölten
Country [21] 0 0
Austria
State/province [21] 0 0
Wels
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Canada
State/province [23] 0 0
Edmonton
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Canada
State/province [24] 0 0
Montréal
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Denmark
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Aalborg
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France
State/province [26] 0 0
Albi
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France
State/province [27] 0 0
Amiens
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France
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Angers
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France
State/province [29] 0 0
Caen
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France
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Carcassonne
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France
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Castres
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France
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Chambéry
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France
State/province [33] 0 0
Grenoble
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France
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La Roche-sur-Yon
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France
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Lille
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France
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Montpellier
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France
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Narbonne
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France
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Nice
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France
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Nîmes
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France
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Orléans
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France
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Paris
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France
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Perpignan
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France
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Pessac
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France
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Pierre-Bénite
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France
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Quimper
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France
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Rodez
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France
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Rouen
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France
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Saint-Brieuc
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France
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Saint-Priest-en-Jarez
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France
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Saint-Quentin
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France
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Toulouse
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Tours
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Troyes
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France
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Vandœuvre-lès-Nancy
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Germany
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Aschaffenburg
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Germany
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Augsburg
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Germany
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Bad Liebenwerda
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Germany
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Donauwörth
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Germany
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Dresden
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Germany
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Flensburg
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Germany
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Frechen
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Germany
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Freiburg im Breisgau
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Germany
State/province [63] 0 0
Göttingen
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Germany
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Halle
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Germany
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Hamburg
Country [66] 0 0
Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Heilbronn
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Germany
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Köln
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Germany
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Landshut
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Germany
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Lebach
Country [72] 0 0
Germany
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Lübeck
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Germany
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Mainz
Country [74] 0 0
Germany
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Münster
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Germany
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Neustadt
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Germany
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Oldenburg In Holstein
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Germany
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Oldenburg
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Germany
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Potsdam
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Germany
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Ratingen
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Germany
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Saarbrücken
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Germany
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Schorndorf
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Germany
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Stuttgart
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Germany
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Villingen Schwenningen
Country [84] 0 0
Germany
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Villingen-Schwenningen
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Germany
State/province [85] 0 0
Wilhelmshaven
Country [86] 0 0
Germany
State/province [86] 0 0
Wolfsburg
Country [87] 0 0
Italy
State/province [87] 0 0
Alessandria
Country [88] 0 0
Italy
State/province [88] 0 0
Ancona
Country [89] 0 0
Italy
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Aviano
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Como
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Italy
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Cremona
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Italy
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Firenze
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Italy
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Lecce
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Italy
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Milano
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Modena
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Perugia
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Italy
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Piacenza
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Italy
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Ponderano
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Italy
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Ravenna
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Italy
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Reggio Calabria
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Italy
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Rimini
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Italy
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Roma
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Italy
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Terni
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Italy
State/province [108] 0 0
Udine
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Italy
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Vicenza
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Hospitalet de Llobregat
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Spain
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Lugo
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Spain
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Madrid
Country [118] 0 0
Spain
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Majadahonda
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Spain
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Palma De Mallorca
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Spain
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Pamplona
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Spain
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Pozuelo De Alarcón
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Spain
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Sabadell
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Taiwan
State/province [128] 0 0
Taichung
Country [129] 0 0
Taiwan
State/province [129] 0 0
Tainan
Country [130] 0 0
Taiwan
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Taipei city
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United Kingdom
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Brighton
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United Kingdom
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Manchester
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United Kingdom
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Sunderland
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United Kingdom
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Taunton
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United Kingdom
State/province [135] 0 0
Truro
Country [136] 0 0
United Kingdom
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Westcliff-on-Sea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MorphoSys AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eva Waltl
Address 0 0
MorphoSys AG
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04697160