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A Trial to Evaluate the Efficacy and Safety of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (B-MIND)

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ClinicalTrials.gov Identifier: NCT02763319
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
MorphoSys AG

Brief Summary:
The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Rituximab (RTX) Drug: MOR208 Drug: Bendamustine (BEN) Phase 2 Phase 3

Detailed Description:
This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of MOR208 in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor: blinding on treatment group
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomised, Multicentre Study of MOR208 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)
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: MOR208 and bendamustine
MOR208 and bendamustine
Drug: MOR208
MOR208: MOR208 dose: 12 mg/kg intravenously (IV)

Drug: Bendamustine (BEN)
Other Name: Levact/Treanda

Active Comparator: Rituximab and bendamustine
Rituximab and bendamustine
Drug: Rituximab (RTX)
Rituximab: Dose: 375 mg/m2 IV
Other Names:
  • Rituxan
  • Mab Thera

Drug: Bendamustine (BEN)
Other Name: Levact/Treanda




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 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 ]
    To determine the efficacy of a combination of MOR208 with BEN versus a combination of RTX with BEN in terms of progression-free survival (PFS) in adult patients with R-R DLBCL.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  2. Duration of response (DoR) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  3. overall survival (OS) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  4. disease control rate (DCR) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  5. time to progression (TTP) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  6. time to next treatment (TTNT) [ Time Frame: From date of randomization assessed up to 4 yrs ]
    To determine efficacy

  7. Number of patients with adverse events [ Time Frame: assessed up to 4 yrs ]
    Number of participants with treatment- and non-treatment related adverse events as assessed by CTCAE

  8. quality of life (QoL) [ Time Frame: assessed up to 4 yrs ]
    EORTC QLQ-C30 and EQ-5D-5L questionnaires will be used

  9. Number of patients developing MOR208 antibodies [ Time Frame: assessed up to 2 yrs ]
  10. Maximum Plasma Concentration of MOR208 (Cmax) [ Time Frame: assessed up to 2 yrs ]
  11. Apparent trough concentration (Cpd) of MOR00208 [ Time Frame: assessed up to 2 yrs ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 MOR00208, 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 MOR00208, 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 MOR00208, 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 MOR00208, 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 MOR00208, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763319


Contacts
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Contact: Ray Valencia, MD +49 89 89927 26611 ray.valencia@morphosys.com

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Locations
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United States, California
MorphoSys Research Site Recruiting
Anaheim, California, United States, 92801
MorphoSys Research Site Recruiting
Bakersfield, California, United States, 93309
Morphosys Research Site Recruiting
Burbank, California, United States, 91505
Contact: Ravi Shankar, MD         
Morphosys Research Site Recruiting
Fresno, California, United States, 93701
Contact: Haifaa Abdulhaq, MD         
MorphoSys Research Site Recruiting
Los Angeles, California, United States, 90017
MorphoSys Research Site Recruiting
Whittier, California, United States, 90603
United States, Connecticut
MorphoSys Research Site Recruiting
Plainville, Connecticut, United States, 06062
United States, Illinois
MorphoSys Research Site Recruiting
Skokie, Illinois, United States, 60077
United States, Michigan
MorphoSys Research Site Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
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Rochester, Minnesota, United States, 55905
United States, Mississippi
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Hattiesburg, Mississippi, United States, 39401
Morphosys Research site Recruiting
Jackson, Mississippi, United States, 39126
Contact: Stephanie Elkins, MD         
United States, New Jersey
Morphosys Research Site Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Charles Farber, MD         
United States, New York
MorphoSys Research Site Recruiting
New York, New York, United States, 10029
MorphoSys Research Site Recruiting
Stony Brook, New York, United States, 11794
United States, Ohio
Morphosys research site Recruiting
Columbus, Ohio, United States, 43202
Contact: Sabarish Ayyappan, MD         
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73142-2015
United States, Tennessee
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Knoxville, Tennessee, United States, 37909
United States, Texas
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Lubbock, Texas, United States, 79415
Contact: Lukman Tijani, MD         
Australia
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Adelaide, Australia, 5000
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Albury, Australia, 2640
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Bedford Park, Australia, 5042
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Box Hill, Australia, 3128
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Concord, Australia, 2139
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Frankston, Australia, 3199
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Garran, Australia, 2605
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Geelong, Australia, 3220
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Gosford, Australia, 2250
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Nedlands, Australia, 6009
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South Brisbane, Australia, 4101
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St. Albans, Australia, 3021
Austria
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Innsbruck, Austria, 6020
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Salzburg, Austria, 5020
Canada, Alberta
Morphosys Research Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Randeep Sangha, MD         
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Jacqueline Costello, MD         
Canada, Ontario
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Kingston, Ontario, Canada, K7L 5P9
Canada, Quebec
MorphoSys Research Site Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Morphosys Research Site Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Isabelle Fleury, MD         
Canada
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Saskatoon, Canada, S7N4H4
Croatia
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Zadar, Croatia, 23000
MorphoSys Research Site Recruiting
Zagreb, Croatia, 10000
Czechia
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Hradec Kralove, Czechia, 50005
Morphosys Research site Recruiting
Olomouc, Czechia, 77900
Contact: Ales Obr, MD         
Morphosys Research Site Recruiting
Prague, Czechia, 12808
Contact: Marek Trneny, Prof         
MorphoSys Research Site Recruiting
Prague, Czechia, 15006
Finland
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Oulu, Finland, 90220
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Tampere, Finland, 33521
France
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Chalon sur Saône, France, 71100
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Grenoble, France, 38043
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Le Mans, France, 72037
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Perigueux, France, 24019
Germany
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Aachen, Germany, 52074
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Berlin, Germany, 10967
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Berlin, Germany, 12351
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Düsseldorf, Germany, 40479
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Giessen, Germany, 35392
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Homburg, Germany, 66421
Contact: Stephan Stilgenbauer, MD         
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Leipzig, Germany, 04103
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Mainz, Germany, 55131
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Munich, Germany, 81737
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Mutlangen, Germany, 73557
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Münster, Germany, 48149
Contact: Andrea Kerkhoff         
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Rostock, Germany, 18057
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Stuttgart, Germany, 70199
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Stuttgart, Germany, 70376
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Traunstein, Germany, 83278
Hungary
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Budapest, Hungary, 1083
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Debrecen, Hungary, 4032
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Győr, Hungary, 9024
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Szeged, Hungary, 6725
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 90131
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
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Petaẖ Tiqwa, Israel, 49100
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Reẖovot, Israel, 76100
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Tel Aviv, Israel, 69710
Italy
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Alessandria, Italy, 15121
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Bologna, Italy, 40138
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Campobasso, Italy, 86100
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Cona, Italy, 44124
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Genova, Italy, 16132
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Lecce, Italy, 73100
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Meldola, Italy, 47014
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Monza, Italy, 20900
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Napoli, Italy, 80131
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Novara, Italy, 28100
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Orbassano, Italy, 10043
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Parma, Italy, 43100
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Pavia, Italy, 27100
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Pisa, Italy, 56126
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Ravenna, Italy, 48121
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Reggio Emilia, Italy, 42100
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Rimini, Italy, 47923
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Rome, Italy, 00128
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Rome, Italy, 00144
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Terni, Italy, 05100
Contact: Anna Marina Liberati, MD         
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Turin, Italy, 10043
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Turin, Italy, 10126
Contact: Umberto Vitolo, MD         
Korea, Republic of
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Busan, Korea, Republic of, 49201
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Goyang-si, Korea, Republic of, 10408
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Incheon, Korea, Republic of, 21565
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Jeonju, Korea, Republic of, 54907
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Seongnam, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 07985
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Seoul, Korea, Republic of, 135710
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Ulsan, Korea, Republic of, 44033
New Zealand
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Addington, New Zealand, 8011
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Auckland, New Zealand, 2025
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Grafton, New Zealand, 1148
Poland
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Bydgoszcz, Poland, 85-796
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Gdansk, Poland, 80-952
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Gdynia, Poland, 81-519
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Kraków, Poland, 30-510
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Legnica, Poland, 59-220
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Lodz, Poland, 93-510
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Lublin, Poland, 20-090
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Warsaw, Poland, 02-776
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Warszawa, Poland, 02781
Contact: Anna Dabrowska-Iwanicka, MD         
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Wrocław, Poland, 50-556
Portugal
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Braga, Portugal, 4710243
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Coimbra, Portugal, 3000-075
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Coimbra, Portugal, 3000075
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Matosinhos, Portugal, 4464-504
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Porto, Portugal, 4099001
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Porto, Portugal, 4200072
Romania
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Bucharest, Romania, 022328
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Bucharest, Romania, 30171
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Iaşi, Romania, 700483
Serbia
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
MorphoSys Research Site Recruiting
Sremska Kamenica, Serbia, 21204
Singapore
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Singapore, Singapore, 119074
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Singapore, Singapore, 169610
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Singapore, Singapore, 188770
MorphoSys Research Site Recruiting
Singapore, Singapore, 258499
Spain
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Cadiz, Spain, 11009
MorphoSys Research Site Recruiting
Girona, Spain, 17007
MorphoSys Research Site Recruiting
L'Hospitalet De Llobregat, Spain, 08908
MorphoSys Research Site Recruiting
Madrid, Spain, 28007
MorphoSys Research Site Recruiting
Madrid, Spain, 28023
MorphoSys Research Site Recruiting
Madrid, Spain, 28050
MorphoSys Research Site Recruiting
Palma de Mallorca, Spain, 07198
MorphoSys Research Site Recruiting
Pamplona, Spain, 31008
MorphoSys Research Site Recruiting
Pozuelo De Alarcón, Spain, 28223
MorphoSys Recruiting
Sabadell, Spain, 08208
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Salamanca, Spain, 37007
MorphoSys Research Site Recruiting
Valencia, Spain, 46940
Taiwan
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Chang Hua, Taiwan, 50006
Contact: Lin Hsuan-Ju, MD         
Morphosys Research Site Recruiting
Hualien City, Taiwan, 97002
Contact: Wang Tso-Fu, MD         
Morphosys Research Site Recruiting
Taichung City, Taiwan, 40447
Contact: Li-Yuan Bai, MD         
Turkey
MorphoSys Research Site Recruiting
Adana, Turkey, 01330
MorphoSys Research Site Recruiting
Ankara, Turkey, 06500
MorphoSys Research Site Recruiting
Ankara, Turkey, 06590
MorphoSys Research Site Recruiting
Bornova, Turkey, 35100
MorphoSys Research Site Recruiting
Gaziantep, Turkey, 27310
MorphoSys Research Site Recruiting
İzmir, Turkey, 35340
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Manisa, Turkey, 45010
MorphoSys Research Site Recruiting
Samsun, Turkey, 55139
United Kingdom
Morphosys Research Site Recruiting
Birmingham, United Kingdom, B71 4HJ
Contact: Farooq Wandroo, MD         
MorphoSys Research Site Recruiting
Leeds, United Kingdom, LS97 TF
MorphoSys Research Site Recruiting
Southend on Sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
MorphoSys AG
ICON Clinical Research
Investigators
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Principal Investigator: Grzegorz Nowakowski, MD Mayo Clinic

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02763319     History of Changes
Other Study ID Numbers: MOR208C204
2014-004689-11 ( EudraCT Number )
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MorphoSys AG:
Diffuse Large B-cell Lymphoma
bendamustine
rituximab
combination therapy
CD19 monoclonal antibody
transplant ineligible

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action