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Completed

NCT Number: 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

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).

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MorphoSys Research Site, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Major Inclusion Criteria:

  • Age >18 years
  • Histologically confirmed diagnosis of DLBCL, not otherwise specified (NOS)
  • Tumor tissue for retrospective central pathology review and correlative studies must be provided.
  • At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • International Prognostic Index (IPI) status of 2 to 5
  • Appropriate candidate for R-CHOP
  • Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
  • Adequate hematologic, liver and renal function
  • 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
  • Males must:
  • use an effective barrier method of contraception if sexually active with FCBP
  • refrain from donating sperm
  • 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:

  • Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
  • Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
  • History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
  • 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
  • History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
  • 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

Treatment and study plan

Tafasitamab

Drug

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

Tafasitamab plus lenalidomide

Drug

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 outcomes

  1. Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

    Time frame: 6 months approximately

Secondary outcomes

  1. Objective Response Rate (ORR) at the End of Treatment (EOT)

    Time frame: 6 months approximately

    The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit.

  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 (FU) Period

    Time frame: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events

  4. Best Objective Response Rate (ORR) Until the End of Study (EOS)

    Time frame: 24 months approximately

    The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS.

  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

    As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used.

  7. Event-free Survival (EFS) at 12 and 24 Months

    Time frame: 24 months approximately

    As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used.

  8. Time to Next Anti-lymphoma Treatment (TTNT)

    Time frame: 24 months approximately

    As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time.

  9. Overall Survival at 12 and 24 Months

    Time frame: 24 months approximately

    As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used.

  10. Anti-tafasitamab Antibodies Formation

    Time frame: 12 months approximately

Sponsors and collaborators

Lead sponsor

MorphoSys AG

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 22, 2019
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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