Risk Stratified Treatment for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia: a Phase I/II Non-Randomized Study of Trametinib and Azacitidine with or Without Chemotherapy
SB
Sandeep Batra, MD
Principal Investigator
Status: Enrolling By Invitation
Ages: 1 Month - 21 Years
Gender: All Genders
Phase: 1/2
2 Locations
Brief Description
This clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML). Newly diagnosed lower-risk JMML patients will receive trametinib and azacitidine. High-risk JMML patients will receive trametinib, azacitidine, fludarabine, and cytarabine.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed Description
- Patients with newly diagnosed lower-risk JMML will be treated with daily azacitidine for 5 days in combination with daily trametinib for 28 days per course for up to 12 courses.
- Patients with newly diagnosed high-risk JMML will be treated with daily azacitidine, fludarabine, and cytarabine for 5 days in combination with daily trametinib for 28 days per course for up to 2 courses.
Eligibility of study
Inclusion Criteria:
Age - Patients must be ≥ 1 month and ≤21 years of age at enrollment.
Diagnosis
- Patients must meet the World Health Organization criteria for JMML. The diagnosis is made based on the following criteria.
1 Month to 21 Years (Child, Adult )
Age - Patients must be ≥ 1 month and ≤21 years of age at enrollment.
Diagnosis
- Patients must meet the World Health Organization criteria for JMML. The diagnosis is made based on the following criteria.
1 Month to 21 Years (Child, Adult )
Interested in participating?
Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.