The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

NCT03920813

Acute Lymphoblastic Leukemia

UNKNOWN PHASE4

Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

NCT02314273

Pancytopenia Due to Chemotherapy

COMPLETED PHASE4

Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate

NCT00898404

B-cell Childhood Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Recurrent Childhood Acute Lymphoblastic Leukemia +1 more

COMPLETED

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

NCT05313958

Leukemia, Monocytic, Acute Pediatric AML

RECRUITING PHASE2/PHASE3

Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

NCT06607419

B-Cell Lymphoblastic Leukemia

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia, Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard treatment regimen

6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.

Group Type ACTIVE_COMPARATOR

6-mercaptopurine

Intervention Type DRUG

6-mercaptopurine was administered orally to patients once daily.

Standard treatment

Intervention Type PROCEDURE

The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.

Individualized treatment regimen

6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.

Group Type EXPERIMENTAL

6-mercaptopurine

Intervention Type DRUG

6-mercaptopurine was administered orally to patients once daily.

Individualized treatment

Intervention Type PROCEDURE

The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

6-mercaptopurine

6-mercaptopurine was administered orally to patients once daily.

Intervention Type DRUG

Standard treatment

The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.

Intervention Type PROCEDURE

Individualized treatment

The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

6-MP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Confirmed diagnosis of acute lymphoblastic leukemia;
2. Age 1-18y at time of initial diagnosis;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Informed consent signed by the patients parents or guardians before initiation of the study.

Exclusion Criteria

1. Ph-positive ALL, matrue B-cell ALL, BC-CML;
2. Secondary to immunodeficiency, second cancer；
3. Abnormal liver and kidney function;
4. Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
5. Patients who enrolled in another clinical trial;
6. Expected survival time less than the treatment cycle;
7. Patients with other factors that researcher considers unsuitable for inclusion

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No