Description:
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).
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
MOR208C107
- NCT ID:
NCT04134936
Conditions
- Diffuse Large B-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Tafasitamab | | Arm A |
Tafasitamab plus lenalidomide | | Arm B |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Tafasitamab in addition to R-CHOP | |
Arm B | Experimental | Tafasitamab plus lenalidomide in addition to R-CHOP | - Tafasitamab plus lenalidomide
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and severity of treatment-emergent adverse events (TEAEs) |
Time Frame: | 6 months approximately |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) at the end of treatment |
Time Frame: | 6 months approximately |
Safety Issue: | |
Description: | |
Measure: | Metabolic, PET-negative complete response (CR) rate at the end of treatment |
Time Frame: | 6 months approximately |
Safety Issue: | |
Description: | |
Measure: | Incidence and severity of adverse events (AEs) in the follow-up period |
Time Frame: | 18 months approximately |
Safety Issue: | |
Description: | |
Measure: | Best Objective Response Rate (ORR) until the end of study |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Metabolic, PET-negative complete response (CR) rate until the end of study |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) at 12 and 24 months |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Event-free survival (EFS) at 12 and 24 months |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Time to next anti-lymphoma treatment (TTNT) |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Overall survival at 12 and 24 months |
Time Frame: | 24 months approximately |
Safety Issue: | |
Description: | |
Measure: | Anti-tafasitamab antibodies formation |
Time Frame: | 12 months approximately |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | MorphoSys AG |
Trial Keywords
- DLBCL
- CD19
- monoclonal antibody
- tafasitamab
- lenalidomide
- MOR208
- MOR00208
Last Updated
October 14, 2020