An azacitidine study for relapsed infant A

Phase 1

• Conditions: Acute lymphoblastic leukemia

• Registration Number: JPRN-jRCTs031180063
• Lead Sponsor: Tomizawa Daisuke

Brief Summary

AZA-MLL-P16 trial is a single center phase I trial to evaluate a safety of hypomethylating agent azacytidine for children with relapsed MLL-rearranged B-ALL who was initially diagnosed at age younger than 2 years old. Total three patients were screened for registration between September 11, 2017 and March 31, 2022, but only one eligible patient could be registered. No DLT in DL1 was observed in that patient. However, DLT of azacitidine could not be evaluated due to an insufficient number of the patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-27
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Patients should meet all the criteria listed below:
(1) Patients must be diagnosed as B-cell precursor acute lymphoblastic leukemia (ALL) with MLL gene rearrangement confirmed by FISH.
(2) Patients must be a first relapsed case.
(3) Patients must be less than 2 years old at the time of initial ALL diagnosis, and less than 7 years old at the time of consent.
(4) Patients must have received at least a single course of standard induction chemotherapy for relapsed ALL.
(5) All patients' parents or legal guardians must sign a written informed consent.
(6) Patients must have performance score (PS) of 0 to 3.
(7) Patients' peripheral blood cell count must be ANC 500/mcL or higher, after 48 hours or longer cessation of G-CSF.
(8) Patients must have sufficient organ function (liver, kidney, heart, lung) at the trial entry;
8-1. SpO2 96% or higher in room air, no abnormal findings in chest X-ray.
8-2. No abnormal ECG and UCG findings which require interventions.
8-3. AST and ALT value within 5 times of normal upper limit.
8-4. Serum bilirubin value within 2 times of normal upper limit.
8-5. Creatinine value within 2 times of normal upper limit.

Exclusion Criteria

Patients should be excluded if either of the below criteria is met:
(1) Patients with uncontrollable infections.
(2) Patients with congenital heart disease that requires any interventions.
(3) Patients with somatic chromosomal abnormalities.
(4) Patients with active hemorrhage at study entry.
(5) Patients with CNS symptoms at study entry.
(6) Patients with other malignant diseases.
(7) Patients who cannot maintain peripheral blood platelet count of 10,000/mcL or higher with transfusions.
(8) Patients not eligible for the study entry decided by the primary/co-investigators of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified