Relationship between pharmacokinetics of melphalan and early post-hematopoietic stem cell transplant complications

An exploratory study of the relationship between pharmacokinetics of melphalan and early post-hematopoietic stem cell transplant complications in allogeneic transplantation using conditioning regimen consisting of fludarabine, cytarabine, melphalan, and low-dose total body irradiation - SCT-MEL-AUC20

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043591

Enrollment

Registered

2021-03-12

Start date

2021-01-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute myelogenous leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients enrolled in AML-SCT15 at a facility participating in the Japan children cancer Group (JCCG) subcommittee on hematological malignancies (JPLSG) who plan to undergo allogeneic transplantation using the FLAMEL regimen and who have obtained written consent from a surrogate for participation in this study

Exclusion criteria

Exclusion criteria: Patients with any other inappropriate status judged by physician

Design outcomes

Primary

Measure	Time frame
Relationship between melphalan-AUC and the frequency of CTC-AE grade 3 or higher for dysphagia and diarrhea up to 28 days after transplantation	—

Secondary

Measure	Time frame
1) Melphalan clearance 2) A relationship between melphalan-AUC and the following parameters: i) age, dose per body weight, pre-transplant Creatinine (Cr), 24-hour Cr clearance, Cystatin-C, and eGFR. ii) Maximum Cr value, minimum eGFR estimated from Cr up to 28 days after transplantation iii) First day of febrile neutropenia and number of days with fever up to 28 days after transplantation iv) First day of opioid use and duration of opioid use up to 28 days after transplantation 3) After completion of the primary analysis of the AML-SCT15 study, the relationship with cumulative incidence of relapse and leukemia-free survival will also be examined.	—

Measure

Time frame

1) Melphalan clearance 2) A relationship between melphalan-AUC and the following parameters: i) age, dose per body weight, pre-transplant Creatinine (Cr), 24-hour Cr clearance, Cystatin-C, and eGFR. ii) Maximum Cr value, minimum eGFR estimated from Cr up to 28 days after transplantation iii) First day of febrile neutropenia and number of days with fever up to 28 days after transplantation iv) First day of opioid use and duration of opioid use up to 28 days after transplantation 3) After completion of the primary analysis of the AML-SCT15 study, the relationship with cumulative incidence of relapse and leukemia-free survival will also be examined.

—

Countries

Japan

Contacts

Public ContactIshida Hiroyuki

Kyoto City Hospital Department of Pediatrics

ishidah@koto.kpu-m.ac.jp075-311-5311

Outcome results