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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 : Recruiting
First Posted : October 22, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

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).

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Tafasitamab Drug: Tafasitamab plus lenalidomide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2022


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

Experimental: Arm B
Tafasitamab plus lenalidomide 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




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 6 months approximately ]

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


Information from the National Library of Medicine

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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

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

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): NCT04134936


Contacts
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Contact: Pia Kloepfer, MD +49 (0)89 899 27-0 pia.kloepfer@morphosys.com

Locations
Show Show 57 study locations
Sponsors and Collaborators
MorphoSys AG
Investigators
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Study Director: Pia Kloepfer, MD MorphoSys AG

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT04134936    
Other Study ID Numbers: MOR208C107
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MorphoSys AG:
DLBCL
CD19
monoclonal antibody
tafasitamab
lenalidomide
MOR208
MOR00208
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
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents