Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL
NCT ID: NCT04134936
Last Updated: 2024-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2019-12-11
2022-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Tafasitamab in addition to R-CHOP
Tafasitamab
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
Arm B
Tafasitamab plus lenalidomide in addition to R-CHOP
Tafasitamab plus lenalidomide
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Interventions
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Tafasitamab
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
Tafasitamab plus lenalidomide
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of DLBCL, not otherwise specified (NOS)
3. Tumor tissue for retrospective central pathology review and correlative studies must be provided.
4. At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
6. International Prognostic Index (IPI) status of 2 to 5
7. Appropriate candidate for R-CHOP
8. Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
9. Adequate hematologic, liver and renal function
10. Females of childbearing potential (FCBP) must:
* not be pregnant
* refrain from breast feeding and donating oocyte
* agree to ongoing pregnancy testing
* commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
11. Males must:
* use an effective barrier method of contraception if sexually active with FCBP
* refrain from donating sperm
12. In the opinion of investigator, the patient must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
Exclusion Criteria
2. Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
3. History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
4. History of prior non-hematologic malignancy except for the following:
* Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
* Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
* Adequately treated carcinoma in situ without current evidence of disease
5. History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
6. Patients with:
* positive test results for active hepatitis B and C
* known seropositive for or history of active viral infection with human immunodeficiency virus (HIV)
* known active bacterial, viral, fungal, mycobacterial, or other infection at screening
* known central nervous system (CNS) lymphoma involvement
* history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator opinion preclude participation in the study
18 Years
ALL
No
Sponsors
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MorphoSys AG
INDUSTRY
Responsible Party
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Locations
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MorphoSys Research Site
Tucson, Arizona, United States
MorphoSys Research Site
Anaheim, California, United States
MorphoSys Research Site
Duarte, California, United States
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Encinitas, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Urbana, Illinois, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Rockville, Maryland, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Eugene, Oregon, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Vancouver, Washington, United States
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Wels, , Austria
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Antwerp, , Belgium
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Antwerp, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Roeselare, , Belgium
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Yvoir, , Belgium
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Bordeaux, , France
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Brest, , France
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Nantes, , France
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Pierre-Bénite, , France
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Aachen, , Germany
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Augsburg, , Germany
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Bonn, , Germany
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Dortmund, , Germany
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Giessen, , Germany
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Göttingen, , Germany
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Halle, , Germany
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Mutlangen, , Germany
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München, , Germany
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München, , Germany
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Nuremberg, , Germany
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Würzburg, , Germany
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Bologna, , Italy
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Ravenna, , Italy
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Barcelona, , Spain
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Cáceres, , Spain
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Girona, , Spain
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Madrid, , Spain
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Sabadell, , Spain
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Seville, , Spain
MorphoSys Research Site
Vitoria-Gasteiz, , Spain
Countries
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References
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Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MOR208C107
Identifier Type: -
Identifier Source: org_study_id
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