Is NCT05849662 recruiting in Indianapolis, IN?

Yes, NCT05849662 is currently recruiting participants at its Indianapolis, IN location. This juvenile myelomonocytic leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Indianapolis 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.

Juvenile Myelomonocytic Leukemia Clinical Trial in Indianapolis, IN

Q: How do I join the juvenile myelomonocytic leukemia clinical trial in Indianapolis?

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

About This Juvenile Myelomonocytic Leukemia Study in Indianapolis

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.

Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Who Can Participate

Inclusion Criteria

Age • Patients must be ≥ 1 month and ≤21 years of age at enrollment. Diagnosis • Patients must meet the 2022 International Consensus Classification criteria for JMML. The diagnosis is made based on the following criteria:. Clinical and hematologic features (the first 2 features are present in most cases; the last 2 are required):

Peripheral blood monocyte count ≥ 1 × 109/L\

Splenomegaly†

Blast percentage in PB and BM \< 20%

Absence of BCR::ABL1

This monocyte threshold is not reached in approximately 7% of cases. †Splenomegaly is absent in 3% of cases at presentation. II. Genetic studies (1 finding required):

Somatic mutation in PTPN11‡ or KRAS‡ or NRAS‡ or RRAS or RRAS2‡

Clinical diagnosis of neurofibromatosis type 1 or germline NF1 mutation and loss of heterozygosity of NF1 or somatic biallelic loss of NF1

Germline CBL mutation and loss of heterozygosity of CBL, or somatic mutation(s) in CBL§

Germline mutations (indicating Noonan syndrome) need to be excluded. §Occasional cases with heterozygous splice site mutations. Performance Level

Karnofsky \> 50% for patients ≥ 16 years of age

Lansky \> 50% for patients \< 16 years of age. Prior Therapy

No prior leukemia directed therapy is permitted with the exception of:

Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of trametinib.

Cytoreduction with 6-mercaptopurine (6-MP) 6-MP can be initiated and continued for up to 72 hours prior to the start of trametinib.

Intrathecal (IT) cytarabine, IT methotrexate or triple IT therapy (cytarabine, methotrexate and hydrocortisone) within 7 days of enrollment as part of a diagnostic evaluation. No prior hematopoietic stem cell transplant is permitted. Adequate Renal Function Defined as:

Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2 OR a normal serum creatinine based on age/gender in the chart below: Maximum Serum Creatinine (mg/dL):

1 month to \< 6 months old - Male: 0.4, Female 0.4

6 months to \<1 year old - Male 0.5, Female 0.5

1 to \< 2 years old - Male: 0.6, Female: 0.6

2 to \< 6 years old - Male:0.8, Female: 0.8

6 to \< 10 years old - Male: 1, Female: 1

10 to \< 13 years old - Male: 1.2, Female: 1.2

13 to \< 16 years old - Male: 1.5, Female: 1.4

≥ 16 years old - Male: 1.7, Female: 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC. Adequate Liver Function Defined as:

Direct bilirubin \< 1.5 x upper limit of normal (ULN) for age or normal, AND alanine transaminase (ALT) \< 5 x ULN for age.

The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia and will not be evaluable for hepatotoxicity. This must be reviewed and approved by the study chair or vice chair. Adequate Cardiac Function Defined as:

Ejection fraction of \> or = to 50% by echocardiogram, OR

Ejection fraction of \> or = to 50% by radionuclide angiogram (MUGA). Reproductive Function

Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.

Female patients with infants must agree not to breastfeed their infants while on this study.

Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria

Patients cannot have a known allergy to any of the drugs used in the study.

Patients cannot have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.

Patients cannot have a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.

Patients cannot have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.

Patients cannot have a clinical or molecular diagnosis of Noonan syndrome. Note: patients with either neurofibromatosis type 1 or Casitas B-lineage lymphoma (CBL) syndrome (also known as Noonan-like syndrome), are eligible to enroll. Patients with Down syndrome are excluded from the study.

Patient cannot have had prior use of hematopoietic growth factors, biologics (anti-neoplastic agent), or XRT.

Patients cannot be taking any medications for treatment of left ventricular systolic dysfunction.

Patients cannot have a history of or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR).

Patients cannot have had prior use of any MEK inhibitor.

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 Indianapolis?

Yes, this clinical trial (NCT05849662) has an active research site in Indianapolis, IN 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.

Juvenile Myelomonocytic Leukemia Treatment Options in Indianapolis, IN

If you're searching for juvenile myelomonocytic leukemia treatment options in Indianapolis, IN, this clinical trial (NCT05849662) 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 Indianapolis research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced juvenile myelomonocytic leukemia 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 juvenile myelomonocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Juvenile Myelomonocytic Leukemia Clinical Trial in Indianapolis, IN

Expert Care in Indianapolis

IRB Approved

No-Cost Care

Apply for This Indianapolis Location

Why Participate?

Simple Process