(Apex) CGT9486 in Patients With Advanced Systemic Mastocytosis

Overview

About this study

The purpose of this study is to investigate CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM. (ASM), System Mastocytosis (SM) with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee

1. Aggressive Systemic Mastocytosis (ASM)

2. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)

3. Mast Cell Leukemia (MCL)

2. Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).

3. ECOG (0 to 3)

4. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.

Key Exclusion Criteria:

1. Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to ≤ Grade 1

2. Associated hematologic neoplasm requiring immediate antineoplastic therapy

3. Clinically significant cardiac disease

4. Known positivity for the FIP1L1-PDGFRA fusion (except for patients who demonstrated relapse or disease progression on prior imatinib therapy). Patients with eosinophilia (eosinophil count >1.5×109 /L) who do not have a detectable KIT D816V mutation must provide documentation of the lack of a PDGFRA fusion mutation by fluorescence in situ hybridization or polymerase chain reaction prior to enrollment.

5. Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody

6. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study

7. Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment

8. Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less
than 28 days, before screening bone marrow biopsy

9. Received hematopoietic growth factor support within 14 days before the first dose of study drug

10. Received strong CYP3A4 inhibitors or inducers before the first dose of study drug

11. Need for treatment with steroids

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/4/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cecilia Arana Yi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions