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

Diffuse Large B-cell Lymphoma Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04134936
• Other study ID #: MOR208C107
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2019
• Est. completion date: August 10, 2022

Study information

• Verified date: March 2023
• Source: MorphoSys AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 10, 2022
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
Austria	MorphoSys Research Site	Graz
Austria	Medizinische Universtät Innsbruck	Innsbruck
Austria	MorphoSys Research Site	Linz
Austria	MorphoSys Research Site	Salzburg
Austria	MorphoSys Research Site	St. Poelten
Austria	MorphoSys Research Site	Vienna
Austria	MorphoSys Research Site	Wels
Belgium	MorphoSys Research Site	Antwerpen
Belgium	MorphoSys Research Site	Antwerpen
Belgium	MorphoSys Research Site	Brussel
Belgium	MorphoSys Research Site	Gent
Belgium	MorphoSys Research Site	Roeselare
Belgium	MorphoSys Research Site	Yvoir
Czechia	MorphoSys Research Site	Hradec Králové
Czechia	MorphoSys Research Site	Ostrava
Czechia	MorphoSys Research Site	Prague
Czechia	MorphoSys Research Site	Prague
Czechia	MorphoSys Research Site	Prague
France	MorphoSys Research Site	Bordeaux 33076
France	MorphoSys Research Site	Brest 29609
France	MorphoSys Research Site	Nantes 44093
France	MorphoSys Research Site	Pierre Benite 69310
Germany	MorphoSys Research Site	Aachen
Germany	MorphoSys Research Site	Augsburg
Germany	MorphoSys Research Site	Bonn
Germany	MorphoSys Research Site	Dortmund
Germany	MorphoSys Research Site	Gießen
Germany	MorphoSys Research Site	Göttingen
Germany	MorphoSys Research Site	Halle
Germany	MorphoSys Research Site	München
Germany	MorphoSys Research Site	München
Germany	MorphoSys Research Site	Mutlangen
Germany	MorphoSys Research Site	Nürnberg
Germany	MorphoSys Research Site	Würzburg
Italy	MorphoSys Research Site	Bologna 40138
Italy	MorphoSys Research Site	Ravenna 48100
Portugal	MorphoSys Research Site	Lisboa
Portugal	MorphoSys Research Site	Lisbon
Portugal	MorphoSys Research Site	Porto
Portugal	MorphoSys Research Site	Porto
Spain	MorphoSys Research Site	Barcelona 8003
Spain	MorphoSys Research Site	Caceres 10003
Spain	MorphoSys Research Site	Girona 17007
Spain	MorphoSys Research Site	Madrid 28041
Spain	MorphoSys Research Site	Sabadell 8208
Spain	MorphoSys Research Site	Sevilla 41013
Spain	MorphoSys Research Site	Vitoria-Gasteiz 1009
United States	MorphoSys Research Site	Anaheim	California
United States	MorphoSys Research Site	Ann Arbor	Michigan
United States	MorphoSys Research Site	Aurora	Colorado
United States	MorphoSys Research Site	Austin	Texas
United States	MorphoSys Research Site	Charleston	South Carolina
United States	MorphoSys Research Site	Cincinnati	Ohio
United States	MorphoSys Research Site	Cleveland	Ohio
United States	MorphoSys Research Site	Covington	Louisiana
United States	MorphoSys Research Site	Dallas	Texas
United States	MorphoSys Research Site	Duarte	California
United States	MorphoSys Research Site	Encinitas	California
United States	MorphoSys Research Site	Eugene	Oregon
United States	MorphoSys Research Site	Houston	Texas
United States	MorphoSys Research Site	Louisville	Kentucky
United States	MorphoSys Research Site	New Haven	Connecticut
United States	MorphoSys Research Site	Rochester	Minnesota
United States	MorphoSys Research Site	Rockville	Maryland
United States	MorphoSys Research Site	San Antonio	Texas
United States	MorphoSys Research Site	Tucson	Arizona
United States	MorphoSys Research Site	Tyler	Texas
United States	MorphoSys Research Site	Urbana	Illinois
United States	MorphoSys Research Site	Vancouver	Washington
United States	MorphoSys Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MorphoSys AG

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  France,  Germany,  Italy,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs)		6 months approximately
Secondary	Objective Response Rate (ORR) at the end of treatment		6 months approximately
Secondary	Metabolic, PET-negative complete response (CR) rate at the end of treatment		6 months approximately
Secondary	Incidence and severity of adverse events (AEs) in the follow-up period		18 months approximately
Secondary	Best Objective Response Rate (ORR) until the end of study		24 months approximately
Secondary	Metabolic, PET-negative complete response (CR) rate until the end of study		24 months approximately
Secondary	Progression-free survival (PFS) at 12 and 24 months		24 months approximately
Secondary	Event-free survival (EFS) at 12 and 24 months		24 months approximately
Secondary	Time to next anti-lymphoma treatment (TTNT)		24 months approximately
Secondary	Overall survival at 12 and 24 months		24 months approximately
Secondary	Anti-tafasitamab antibodies formation		12 months approximately