Myelodysplastic Syndrome Clinical Trial

Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

Summary

The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patients must have a diagnosis prior to participation in the study of IPSS-R very low, low, or intermediate risk MDS with ≤10% bone marrow blasts and one or more of the following:

Symptomatic anemia with hemoglobin <10 gdL that has relapsed after or is refractory to ESAs (or the patient intolerant ESAs)
Symptomatic anemia with hemoglobin <10 gdL) that is ESA-naive with EPO level ≥ 500 > Thrombocytopenia with platelets <30,000/uL or with clinically significant bleeding or bruising and platelets <50,000/uL
Neutropenia with an absolute neutrophil count (ANC) <500> Patients who are refractory to, intolerant of, or ineligible/unable to receive SOC therapeutic options including lenalidomide
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions' guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study -

Key Exclusion Criteria:

Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
Patients with chronic myelomonocytic leukemia (CMML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN)
Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or ESAs anytime ≤ 2 weeks (or 5 half-lives, whichever is longer) prior to start of study treatment.
Systemic chronic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
For arms containing canakinumab: Patients with ANC < 500 /µL

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04810611

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 14 Locations for this study

See Locations Near You

H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Chelsea Conner
Contact
813-972-8391
[email protected]
David Sallman
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Tayna Behnan
Contact
[email protected]
Andrew M Brunner
Principal Investigator
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States More Info
Jake Morgan
Contact
641-239-3316
[email protected]
Uma Borate
Principal Investigator
MD Anderson Cancer Center/University of Texas MD Anderson
Houston Texas, 77030, United States More Info
Bailey Mirabella
Contact
713-792-7305
[email protected]
Guillermo Garcia-Manero
Principal Investigator
Novartis Investigative Site
Adelaide South Australia, 5000, Australia
Novartis Investigative Site
Prahran Victoria, 3181, Australia
Novartis Investigative Site
Tianjin Tianjin, 30002, China
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Milano MI, 20162, Italy
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Singapore , 11922, Singapore
Novartis Investigative Site
Singapore , 16960, Singapore
Novartis Investigative Site
Salamanca Castilla Y Leon, 37007, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04810611

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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