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New treatment option for Systemic Mastocytosis With an Associated Hematologic Neoplasm
Official title Avapritinib With Decitabine in Patients With SM-AHN
ClinicalTrials.gov ID: NCT06327685
What this study is testing
What is Avapritinib?
Avapritinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic mastocytosis with an associated hematologic neoplasm.
Also referred to as Ayvakit.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of SM-AHN defined by World Health Organization 2022 criteria.
- ECOG 0-3
- Ability to understand and the willingness to sign a written informed consent.
- Ability to adhere to study visit schedule and other protocol requirements.
- Willing to receive blood products as deemed clinically necessary.
You likely can't join if
- History of decitabine use with documented disease progression of AHN by 2006 IWG MDS response criteria while on decitabine.
- History of avapritinib use with documented progression of mastocytosis while on avapritinib per m-IWG-MRT-ECNM criteria.
- History of treatment with decitabine in combination with avapritinib.
- Use of azacitidine within 4 weeks of first dose of study drug.
- Diagnosis of AML defined as presence of ≥ 20% myeloblasts in the peripheral blood or bone marrow or presence of a myeloid sarcoma.
- Patients who are receiving any other investigational agents or are participating in another treatment study.
See the full eligibility criteria
- Diagnosis of SM-AHN defined by World Health Organization 2022 criteria.
- ECOG 0-3
- Ability to understand and the willingness to sign a written informed consent.
- Ability to adhere to study visit schedule and other protocol requirements.
- Willing to receive blood products as deemed clinically necessary.
- Adequate organ and marrow function as defined by the protocol.
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association...
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least...
- History of decitabine use with documented disease progression of AHN by 2006 IWG MDS response criteria while on decitabine.
- History of avapritinib use with documented progression of mastocytosis while on avapritinib per m-IWG-MRT-ECNM criteria.
- History of treatment with decitabine in combination with avapritinib.
- Use of azacitidine within 4 weeks of first dose of study drug.
- Diagnosis of AML defined as presence of ≥ 20% myeloblasts in the peripheral blood or bone marrow or presence of a myeloid sarcoma.
- Patients who are receiving any other investigational agents or are participating in another treatment study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacytidine, decitabine, cedazuridine, avapritinib, propylene glycol, mannitol (only for patients receiving...
- History of intracranial hemorrhage or need for full anticoagulation with warfarin, direct oral anticoagulant, or treatment dose low molecular weight heparin (LMWH), or any condition that, in the investigator's opinion...
- Patient has a history of a seizure disorder (eg, epilepsy) or requirement for antiseizure medication.
- Patient has a QT interval corrected using Fridericia's formula (QTcF) \> 480 msec.
- Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant related immunosuppression.
- Patients receiving any medications or substances that are strong or moderate CYP3A inhibitors or strong or moderate CYP3A inducers. Because the lists of these agents are constantly changing, it is important to regularly...
- Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because, based on the mechanism of action and data from animal reproduction studies, in utero exposure to avapritinib may cause fetal harm.
- Women who are breast feeding.
- Patient is unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Patient has a primary brain malignancy or metastases to the brain.
- Patient has had a major surgical procedure within 14 days of the first dose of study drug. Surgical procedures such as central venous catheter placement, bone marrow (BM) biopsy, and feeding tube placement are...
- Patient has eosinophilia and known positivity for the FIP1L1-PGDFRA fusion, unless the patient has demonstrated relapse or progressive disease (PD) on prior imatinib therapy. Patients with eosinophilia (\> 1.5 × 109/L)...
- Patient is participating in another treatment clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Palo Alto, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Palo Alto, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.