Clinical trial NCT04134936: 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
Official title: A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
CD19
monoclonal antibody
tafasitamab
lenalidomide
MOR208
MOR00208
Lead sponsor: MorphoSys AG
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).


Eligibility criteria: Major Inclusion Criteria:

1. Age \>18 years
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

Major Exclusion Criteria:

1. Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
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

Primary outcomes:
measure: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
timeFrame: 6 months approximately
Secondary outcomes:
measure: Objective Response Rate (ORR) at the End of Treatment (EOT)
timeFrame: 6 months approximately
measure: Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment
timeFrame: 6 months approximately
measure: Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period
timeFrame: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events
measure: Best Objective Response Rate (ORR) Until the End of Study (EOS)
timeFrame: 24 months approximately
measure: Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study
timeFrame: 24 months approximately
measure: Progression-free Survival (PFS) at 12 and 24 Months
timeFrame: 24 months approximately
measure: Event-free Survival (EFS) at 12 and 24 Months
timeFrame: 24 months approximately
measure: Time to Next Anti-lymphoma Treatment (TTNT)
timeFrame: 24 months approximately
measure: Overall Survival at 12 and 24 Months
timeFrame: 24 months approximately
measure: Anti-tafasitamab Antibodies Formation
timeFrame: 12 months approximately
Other outcomes:
Locations:
city: Tucson
country: United States
facility: MorphoSys Research Site
state: Arizona
city: Anaheim
country: United States
facility: MorphoSys Research Site
state: California
city: Duarte
country: United States
facility: MorphoSys Research Site
state: California
city: Encinitas
country: United States
facility: MorphoSys Research Site
state: California
city: Aurora
country: United States
facility: MorphoSys Research Site
state: Colorado
city: New Haven
country: United States
facility: MorphoSys Research Site
state: Connecticut
city: Washington
country: United States
facility: MorphoSys Research Site
state: District of Columbia
city: Urbana
country: United States
facility: MorphoSys Research Site
state: Illinois
city: Louisville
country: United States
facility: MorphoSys Research Site
state: Kentucky
city: Covington
country: United States
facility: MorphoSys Research Site
state: Louisiana
city: Rockville
country: United States
facility: MorphoSys Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: MorphoSys Research Site
state: Michigan
city: Rochester
country: United States
facility: MorphoSys Research Site
state: Minnesota
city: Cincinnati
country: United States
facility: MorphoSys Research Site
state: Ohio
city: Cleveland
country: United States
facility: MorphoSys Research Site
state: Ohio
city: Eugene
country: United States
facility: MorphoSys Research Site
state: Oregon
city: Charleston
country: United States
facility: MorphoSys Research Site
state: South Carolina
city: Austin
country: United States
facility: MorphoSys Research Site
state: Texas
city: Dallas
country: United States
facility: MorphoSys Research Site
state: Texas
city: Houston
country: United States
facility: MorphoSys Research Site
state: Texas
city: San Antonio
country: United States
facility: MorphoSys Research Site
state: Texas
city: Tyler
country: United States
facility: MorphoSys Research Site
state: Texas
city: Vancouver
country: United States
facility: MorphoSys Research Site
state: Washington
city: Graz
country: Austria
facility: MorphoSys Research Site
city: Innsbruck
country: Austria
facility: MorphoSys Research Site
city: Linz
country: Austria
facility: MorphoSys Research Site
city: Salzburg
country: Austria
facility: MorphoSys Research Site
city: St. Poelten
country: Austria
facility: MorphoSys Research Site
city: Vienna
country: Austria
facility: MorphoSys Research Site
city: Wels
country: Austria
facility: MorphoSys Research Site
city: Antwerpen
country: Belgium
facility: MorphoSys Research Site
city: Antwerpen
country: Belgium
facility: MorphoSys Research Site
city: Brussel
country: Belgium
facility: MorphoSys Research Site
city: Gent
country: Belgium
facility: MorphoSys Research Site
city: Roeselare
country: Belgium
facility: MorphoSys Research Site
city: Yvoir
country: Belgium
facility: MorphoSys Research Site
city: Hradec Králové
country: Czechia
facility: MorphoSys Research Site
city: Ostrava
country: Czechia
facility: MorphoSys Research Site
city: Prague
country: Czechia
facility: MorphoSys Research Site
city: Prague
country: Czechia
facility: MorphoSys Research Site
city: Prague
country: Czechia
facility: MorphoSys Research Site
city: Bordeaux 33076
country: France
facility: MorphoSys Research Site
city: Brest 29609
country: France
facility: MorphoSys Research Site
city: Nantes 44093
country: France
facility: MorphoSys Research Site
city: Pierre Benite 69310
country: France
facility: MorphoSys Research Site
city: Aachen
country: Germany
facility: MorphoSys Research Site
city: Augsburg
country: Germany
facility: MorphoSys Research Site
city: Bonn
country: Germany
facility: MorphoSys Research Site
city: Dortmund
country: Germany
facility: MorphoSys Research Site
city: Gießen
country: Germany
facility: MorphoSys Research Site
city: Göttingen
country: Germany
facility: MorphoSys Research Site
city: Halle
country: Germany
facility: MorphoSys Research Site
city: Mutlangen
country: Germany
facility: MorphoSys Research Site
city: München
country: Germany
facility: MorphoSys Research Site
city: München
country: Germany
facility: MorphoSys Research Site
city: Nürnberg
country: Germany
facility: MorphoSys Research Site
city: Würzburg
country: Germany
facility: MorphoSys Research Site
city: Bologna 40138
country: Italy
facility: MorphoSys Research Site
city: Ravenna 48100
country: Italy
facility: MorphoSys Research Site
city: Lisboa
country: Portugal
facility: MorphoSys Research Site
city: Lisbon
country: Portugal
facility: MorphoSys Research Site
city: Porto
country: Portugal
facility: MorphoSys Research Site
city: Porto
country: Portugal
facility: MorphoSys Research Site
city: Barcelona 8003
country: Spain
facility: MorphoSys Research Site
city: Caceres 10003
country: Spain
facility: MorphoSys Research Site
city: Girona 17007
country: Spain
facility: MorphoSys Research Site
city: Madrid 28041
country: Spain
facility: MorphoSys Research Site
city: Sabadell 8208
country: Spain
facility: MorphoSys Research Site
city: Sevilla 41013
country: Spain
facility: MorphoSys Research Site
city: Vitoria-Gasteiz 1009
country: Spain
facility: MorphoSys Research Site
Study officials:
References: