Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

NCT ID: NCT02639910

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2021-12-31

Brief Summary

This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.

Detailed Description

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee.

An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

CD19; MOR208; MOR00208; CLL; SLL; COSMOS; tafasitamab

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

tafasitamab (MOR208) in combination with idelalisib

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: BIOLOGICAL

tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion

Idelalisib

Intervention Type: DRUG

idelalisib dose: 150 mg twice daily orally

Cohort B

tafasitamab (MOR208) in combination with venetoclax

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: BIOLOGICAL

tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion

Venetoclax

Intervention Type: DRUG

venetoclax dose: 400 mg once daily orally

Interventions

Tafasitamab

tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion

Intervention Type: BIOLOGICAL

Idelalisib

idelalisib dose: 150 mg twice daily orally

Intervention Type: DRUG

Venetoclax

venetoclax dose: 400 mg once daily orally

Intervention Type: DRUG

Other Intervention Names

MOR208; MOR00208; Zydelig; GS-1101 or CAL-101; Venclexta, Venclyxto; ABT-199

Eligibility Criteria

Inclusion Criteria

Diagnosis/Trial Population

• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

• history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
• histologically confirmed diagnosis of SLL by lymph node biopsy
• indication for treatment as defined by the IWCLL guidelines
• Patients must have both of the following:

• relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
• single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
• ECOG performance status of 0 to 2
• Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery

Laboratory Values

• Patients must meet adequate bone marrow function and adequate hepatic and renal function

• Females of childbearing potential must use a highly effective method of contraception

Exclusion Criteria

Diagnosis

• Patients who have:

• non-Hodgkin's lymphomas other than CLL/SLL
• transformed CLL/SLL or Richter's syndrome
• active and uncontrolled autoimmune cytopenia

Previous and Current Treatment

• Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing
• Patients who have, within 14 days prior to D1 dosing:

• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
• received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MorphoSys AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anke Muth

Role: STUDY_DIRECTOR

Clinical Development, MorphoSys AG

Locations

Clinical Study Site

Jacksonville, Florida, United States

Clinical Study Site

Rochester, Minnesota, United States

Clinical Study Site

Columbus, Ohio, United States

Clinical Study Site

Graz, , Austria

Clinical Study Site

Salzburg, , Austria

Clinical Study Site

Vienna, , Austria

Clinical Study Site

Dresden, , Germany

Clinical Study Site

Leipzig, , Germany

Clinical Study Site

München, , Germany

Clinical Study Site

Brescia, , Italy

Clinical Study Site

Milan, , Italy

Clinical Study Site

Gdansk, , Poland

Clinical Study Site

Krakow, , Poland

Clinical Study Site

Lublin, , Poland

Clinical Study Site

Opole, , Poland

Clinical Study Site

Bournemouth, , United Kingdom

Clinical Study Site

Leeds, , United Kingdom

Countries

France; United States; Austria; Germany; Italy; Poland; United Kingdom

References

Staber PB, Jurczak W, Greil R, Vucinic V, Middeke JM, Montillo M, Munir T, Neumeister P, Schetelig J, Stilgenbauer S, Striebel F, Dirnberger-Hertweck M, Weirather J, Brugger W, Kelemen P, Wendtner CM, Woyach JA. Tafasitamab combined with idelalisib or venetoclax in patients with CLL previously treated with a BTK inhibitor. Leuk Lymphoma. 2021 Dec;62(14):3440-3451. doi: 10.1080/10428194.2021.1964020. Epub 2021 Aug 20.

Reference Type: DERIVED

PMID: 34414843 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MOR208C205

Identifier Type: -

Identifier Source: org_study_id