Is NCT04996875 recruiting in Atlanta, GA?

Yes, NCT04996875 is currently recruiting participants at its Atlanta, GA location. This systemic mastocytosis clinical trial is actively enrolling qualified participants.

How do I join the systemic mastocytosis clinical trial in Atlanta?

To join this clinical trial in Atlanta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Atlanta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Systemic Mastocytosis Clinical Trial in Atlanta, GA

About This Systemic Mastocytosis Study in Atlanta

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Sponsor: Cogent Biosciences, Inc.

Who Can Participate

Inclusion Criteria

for Main Study:

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

Aggressive Systemic Mastocytosis (ASM)

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

Mast Cell Leukemia (MCL)

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

ECOG (0 to 3)

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

Exclusion Criteria

for Main Study:

Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1

Associated hematologic neoplasm requiring immediate antineoplastic therapy

Clinically significant cardiac disease

Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment

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

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

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

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

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

Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug

Need for treatment with high dose steroids Key Inclusion Criteria for Substudy Population: Rollover Cohort

Demonstrate AHN progression requiring immediate AHN-directed therapy while receiving bezuclastinib

Demonstrated clinical benefit from bezuclastinib therapy

Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits High-Risk Cohort

Receiving or indicated for AHN-directed therapy.

Diagnosed with one of the following pathologic diagnoses of SM-AHN:

Myelodysplastic syndrome (MDS) that is high- or very high-risk

Accelerated phase myeloproliferative neoplasm (MPN)

MDS with excessive blasts in bone marrow or peripheral blood

Chronic myelomonocytic leukemia-2 (CMML-2)

Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits. Key Exclusion Criteria for Substudy Population:

Diagnosis of Philadelphia chromosome-positive malignancy

Diagnosis of acute myeloid leukemia (AML)

Appropriate for allogenic hematopoietic stem cell transplantation

Any contraindication to selected concomitant therapy

Rollover Cohort: Have not demonstrated acceptable tolerability of previous bezuclastinib therapy

High-Risk Cohort: Previously treated with investigational therapy for AdvSM

High-Risk Cohort: Previously treated with cytoreductive therapy and discontinued due to treatment-related toxicity

High-Risk Cohort: 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 or archival bone marrow biopsy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT04996875) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Systemic Mastocytosis Treatment Options in Atlanta, GA

If you're searching for systemic mastocytosis treatment options in Atlanta, GA, this clinical trial (NCT04996875) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced systemic mastocytosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all systemic mastocytosis clinical trials near you to find additional studies recruiting in your area.

Systemic Mastocytosis Clinical Trial in Atlanta, GA

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