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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

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ClinicalTrials.gov Identifier: NCT04134936
Recruitment Status : Active, not recruiting
First Posted : October 22, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Tracking Information
First Submitted Date  ICMJE October 11, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 6 months approximately ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czechia,   France,   Germany,   Italy,   Portugal,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04134936
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party MorphoSys AG
Study Sponsor  ICMJE MorphoSys AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pia Kloepfer, MD MorphoSys AG
PRS Account MorphoSys AG
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP