NCT02639910

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_2

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 15, 2015

Results QC Date

December 13, 2019

Last Update Submit

December 10, 2021

Conditions

Leukemia, Lymphocytic, Chronic, B-CellChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Keywords

CD19MOR208MOR00208CLLSLLCOSMOStafasitamab

Outcome Measures

Primary Outcomes (1)

  • Incidence and Severity of Adverse Events (AEs)

    For details please see Section of Adverse Events Overview

    2 years

Secondary Outcomes (3)

  • Best Objective Response Rate (ORR)

    2 years

  • Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation

    2 years

  • Maximum Plasma Concentration (Cmax) of MOR00208

    At Cycle 3 Day 15

Other Outcomes (1)

  • Proportion of Patients With MRD-negativity

    2 years

Study Arms (2)

Cohort A

EXPERIMENTAL

tafasitamab (MOR208) in combination with idelalisib

Biological: TafasitamabDrug: Idelalisib

Cohort B

EXPERIMENTAL

tafasitamab (MOR208) in combination with venetoclax

Biological: TafasitamabDrug: Venetoclax

Interventions

TafasitamabBIOLOGICAL

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

Also known as: MOR208, MOR00208
Cohort ACohort B
IdelalisibDRUG

idelalisib dose: 150 mg twice daily orally

Also known as: Zydelig; GS-1101 or CAL-101
Cohort A
VenetoclaxDRUG

venetoclax dose: 400 mg once daily orally

Also known as: Venclexta, Venclyxto; ABT-199
Cohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Clinical Study Site

Jacksonville, Florida, 32204, United States

Location

Clinical Study Site

Rochester, Minnesota, 55905, United States

Location

Clinical Study Site

Columbus, Ohio, 43210, United States

Location

Clinical Study Site

Graz, 8036, Austria

Location

Clinical Study Site

Salzburg, 5020, Austria

Location

Clinical Study Site

Vienna, 1090, Austria

Location

Clinical Study Site

Dresden, 1307, Germany

Location

Clinical Study Site

Leipzig, 4103, Germany

Location

Clinical Study Site

München, 80804, Germany

Location

Clinical Study Site

Brescia, 25123, Italy

Location

Clinical Study Site

Milan, 20162, Italy

Location

Clinical Study Site

Gdansk, 80952, Poland

Location

Clinical Study Site

Krakow, 30510, Poland

Location

Clinical Study Site

Lublin, 85094, Poland

Location

Clinical Study Site

Opole, 45372, Poland

Location

Clinical Study Site

Bournemouth, BH7 7DW, United Kingdom

Location

Clinical Study Site

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34414843DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tafasitamabidelalisibvenetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Peter Kelemen MD, PhD - Director, Clinical Program Leader
Organization
MorphoSys AG
peter.kelemen@morphosys.com
+498989927

Study Officials

  • Anke Muth

    Clinical Development, MorphoSys AG

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 28, 2015

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2021

Last Updated

December 20, 2021

Results First Posted

January 30, 2020

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)US(3)DE(3)PL(4)GB(2)IT(2)