Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

NCT03255668 | Completed

• 1 other identifier: IndonesiaFKUI
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects who are recruited in this study are LLA patient, who are treated for routine control to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion criteria.

Conditions

Mercaptopurine Adverse Reaction; Leukemia, Lymphoblastic

Keywords

Mercaptopurine, acute lymphoblastic leukemia, hematotoxicity

Outcome Measures

Primary Outcomes (1)

• Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping

  Haematology data (hemoglobin, leukocites, platelets, absolute neutrophil count), TPMT genotyping, and blood concentration of 6-meMP and 6-TGN (=phenotyping).

  August 2017 - May 2018

Secondary Outcomes (1)

• other Factors that can influence the incidence of hematotoxicity

  July 2017 - May 2018

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with LLA who received 6-MP chemotherapy in the maintenance phase, who come to RSCM, and who meets the inclusion criteria and does not meet the exclusion criteria.

You may qualify if:

• Acute lymphoblastic leukemia (ALL) patients, 1 until 18 years old, male or female, who come to Cipto Mangunkusumo Hospital, Jakarta, Indonesia
• Received 6MP chemotherapy at least 1 month maintenance phase
• Received maintenance phase treatment regimen
• Willing to participate in research, signed informed consent and obtained parental consent to participate in research

You may not qualify if:

• Patients are experiencing severe infections
• Patients receiving colony stimulating factor (CSF), allopurinol, mesalazine, olsalazine, and sulfasalazine

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rianto Setiabudy, Professor

  Department of Pharmacology and therapeutic, FMUI

  STUDY DIRECTOR

• Djajadiman Gatot, Professor

  Department of Pediatric

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, MSc

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: July 25, 2017
• Primary Completion: October 15, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)