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

• ClinicalTrials.gov Identifier: NCT04134936
• Recruitment Status: Completed
• First Posted: October 22, 2019
• Last Update Posted: March 15, 2023
• Sponsor: MorphoSys AG
• Information provided by (Responsible Party): MorphoSys AG

Tracking Information

• First Submitted Date: October 11, 2019
• First Posted Date: October 22, 2019
• Last Update Posted Date: March 15, 2023
• Actual Study Start Date: December 11, 2019
• Actual Primary Completion Date: February 11, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 21, 2019): Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 6 months approximately ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2019)

• Objective Response Rate (ORR) at the end of treatment [ Time Frame: 6 months approximately ]
• Metabolic, PET-negative complete response (CR) rate at the end of treatment [ Time Frame: 6 months approximately ]
• Incidence and severity of adverse events (AEs) in the follow-up period [ Time Frame: 18 months approximately ]
• Best Objective Response Rate (ORR) until the end of study [ Time Frame: 24 months approximately ]
• Metabolic, PET-negative complete response (CR) rate until the end of study [ Time Frame: 24 months approximately ]
• Progression-free survival (PFS) at 12 and 24 months [ Time Frame: 24 months approximately ]
• Event-free survival (EFS) at 12 and 24 months [ Time Frame: 24 months approximately ]
• Time to next anti-lymphoma treatment (TTNT) [ Time Frame: 24 months approximately ]
• Overall survival at 12 and 24 months [ Time Frame: 24 months approximately ]
• Anti-tafasitamab antibodies formation [ Time Frame: 12 months approximately ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diffuse Large B-cell Lymphoma

Intervention

• Drug: Tafasitamab
  Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
• Drug: 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

Study Arms

• Experimental: Arm A
  Tafasitamab in addition to R-CHOP
  Intervention: Drug: Tafasitamab
• Experimental: Arm B
  Tafasitamab plus lenalidomide in addition to R-CHOP
  Intervention: Drug: Tafasitamab plus lenalidomide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2023): 66
• Original Estimated Enrollment (submitted: October 21, 2019): 60
• Actual Study Completion Date: August 10, 2022
• Actual Primary Completion Date: February 11, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Czechia, France, Germany, Italy, Portugal, Spain, United States

Administrative Information

• NCT Number: NCT04134936
• Other Study ID Numbers: MOR208C107
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: MorphoSys AG
• Original Responsible Party: Same as current
• Current Study Sponsor: MorphoSys AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pia Kloepfer, MD; MorphoSys AG

• PRS Account: MorphoSys AG
• Verification Date: March 2023