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A prospective clinical study to evaluate the efficacy of dexitabine in maintenance therapy after hematopoietic stem cell transplantation in juvenile myelomonocytic leukemia

A prospective clinical study to evaluate the efficacy of dexitabine in maintenance therapy after hematopoietic stem cell transplantation in juvenile myelomonocytic leukemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091166
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Myelomonocytic Leukemia

Interventions

Test group:The first course of treatment of dexitabine was 10mg/m2 /day(5 days in total), starting the next course 4-6 weeks after the end of the previous course of treatment until all immunosuppressa

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1)Age = 1 month and = 18 years old, regardless of sex; (2)Diagnosis of JMML according to WHO criteria: I.clinical and hematological features (4 items were consistent): 1.Peripheral blood mononuclear cell count = 1X109/L; 2.Blast percentage in PB and BM 0.5 X 109 / L for 3 consecutive days 2.Platelet engraftment: platelet count > 20 X 109 × L for 7 consecutive days without infusion (4)Normal liver, kidney and heart function: 1. 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 or = to 50% by echocardiogram, OR Ejection fraction of > or = to 50% by radionuclide angiogram (MUGA). (5)The subjects or their legal guardians voluntarily participated in the experiment and signed an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (1)Male and female patients who plan to prepare for pregnancy during this study or within 6 months after treatment (2)Pregnant women (3)Do not have a known history of allergy to any drug used in the study (4)There are serious, uncontrollable systemic bacterial, fungal, viral or other pathogen infections (5)During the period of this study, patients plan to receive chemotherapy, radiotherapy or cellular immunotherapy in addition to this regimen. (6)Suffering from severe complications after HSCT. (7)Suffering from Down syndrome, immunodeficiency disease and secondary tumor (8)Severe heart, lung, liver and kidney dysfunction cannot tolerate drug treatment (9)Engraftment failure or mixed chimerism after HSCT (10)Have a mental disorder or serious mental illness

Design outcomes

Primary

MeasureTime frame
Dose-limited toxicity;

Secondary

MeasureTime frame
Overall survival time;Event free survival time;Progression free survival;

Countries

China

Contacts

Public ContactChunChen

The Seventh Affiliated Hospital, Sun Yat-sen University

chenchun@mail.sysu.edu.cn+86 137 1900 3063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026