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Leukemia, Lymphocytic, Chronic, B-CellPhase 2COSMOSNCT02639910

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

A Phase 2 study testing Tafasitamab, Idelalisib and Venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Chronic Lymphocytic Leukemia, run by MorphoSys AG at 17 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tafasitamab, Idelalisib and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
17 sitesin 6 countries
Study dates
Nov 2016to Dec 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Major 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

Other Inclusion Criteria

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

Major 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

Trial locations and contacts

17 sites in 6 countries.

17 sites in 6 countries

Poland4 sites

  • Clinical Study Site

    Gdansk, 80952

  • Clinical Study Site

    Krakow, 30510

  • Clinical Study Site

    Lublin, 85094

  • Clinical Study Site

    Opole, 45372

Other trials in Poland

United States3 sites

  • Clinical Study Site

    Columbus, Ohio, 43210

  • Clinical Study Site

    Jacksonville, Florida, 32204

  • Clinical Study Site

    Rochester, Minnesota, 55905

Other trials in United States

Austria3 sites

  • Clinical Study Site

    Graz, 8036

  • Clinical Study Site

    Salzburg, 5020

  • Clinical Study Site

    Vienna, 1090

Other trials in Austria

Germany3 sites

  • Clinical Study Site

    Dresden, 1307

  • Clinical Study Site

    Leipzig, 4103

  • Clinical Study Site

    München, 80804

Other trials in Germany

Italy2 sites

  • Clinical Study Site

    Brescia, 25123

  • Clinical Study Site

    Milan, 20162

Other trials in Italy

United Kingdom2 sites

  • Clinical Study Site

    Bournemouth, BH7 7DW

  • Clinical Study Site

    Leeds, LS9 7TF

Other trials in United Kingdom

About this study

Official title: A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor

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.

Read the 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.

Being tested
Tafasitamab, Idelalisib, Venetoclax
Keywords
CD19, MOR208, MOR00208, CLL, SLL, COSMOS, tafasitamab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafasitamabBiological

    Also called MOR208, MOR00208

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

  • IdelalisibDrug

    Also called Zydelig; GS-1101 or CAL-101

    idelalisib dose: 150 mg twice daily orally

  • VenetoclaxDrug

    Also called Venclexta, Venclyxto; ABT-199

    venetoclax dose: 400 mg once daily orally

Study groups in NCT02639910
Study groupRoleWhat they receive
Cohort AExperimentaltafasitamab (MOR208) in combination with idelalisib
Receives: Biological: Tafasitamab; Drug: Idelalisib
Cohort BExperimentaltafasitamab (MOR208) in combination with venetoclax
Receives: Biological: Tafasitamab; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity of Adverse Events (AEs)

    For details please see Section of Adverse Events Overview

    Measured: 2 years

Secondary outcomes (3)

  1. Best Objective Response Rate (ORR)

    ORR = complete response [CR] + partial response [PR]; Local Evaluation

    Measured: 2 years

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

    Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation

    Measured: 2 years

  3. Maximum Plasma Concentration (Cmax) of MOR00208

    Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)

    Measured: At Cycle 3 Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2015 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2018
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02639910
Sponsor's protocol ID
MOR208C205
Acronym
COSMOS
Status last verified
Dec 2021
First submitted
15 Dec 2015
Last updated
20 Dec 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34414843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab, Idelalisib and Venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Chronic Lymphocytic Leukemia, run by MorphoSys AG at 17 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Poland, United States, Austria, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (AEs) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02639910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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