Skip to content

Improved Post-Transplant Cyclophosphamide Regimens for Pediatric Patients With Refractory AML

Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03654703
Enrollment
100
Registered
2018-08-31
Start date
2015-03-01
Completion date
2020-03-01
Last updated
2018-08-31

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

Conditions

Hematopoietic System--Cancer

Keywords

HSCT, AML, R-AML

Brief summary

No more datas about post-transplant cyclophosphamide (PT/Cy) used in pediatric refractory acute myeloid leukemia (R-AML)patients. Investigators reasoned that this group of patients if they have been treated with ablative conditioning regimens for HSCT combined with PT/Cy, under the rapid of immune reconstitution will have better outcomes.

Detailed description

Haploidentical stem cell transplantation (HSCT) is a potentially curative therapy for patients with high risk or refractory acute myeloid leukemia (R-AML). Graft-versus-host disease (GVHD)is a major barrier to achieve success for patients with HSCT. High dose cyclophosphamide given after HLA-matched related and unrelated allogeneic stem cell transplantation for patients with hematologic malignancies is effective single agent (GVHD) prophylaxis in adults and in pediatric benign patients. Data describing outcomes for pediatric maligant patients has not been reported. Investigators have recruited 26 pediatric patients (3 years \< age \<18 years) between March 2015 to July 2018 with primary induction R-AML treated in investigators' institution for R-AML with modified myeloablative regimen, post-transplant cyclophosphamide (PTCy) has been used as GVHD prophylaxis. Conditioning regimen of the group of patient consisted Idrabine(IDA,10mg/m2/day) which was administered intravenously for 2 days, from days -14 to -13, total body irritation (TBI, 9 Gy) which was divided into 3 fractions and 3 days from -12 to -10, thymoglobulin (2.5mg/kg/day) was administered for 3 days, from -9 to -7, etoposide (VP-16, 300mg/m2) which was infused intravenously on day -6, cladribine (10mg/m2/day) which was administered for 3 days from -5 to -2 .

Interventions

DRUGCyclophosphamide

cyclophophamide

Sponsors

Capital Research Institute of Pediatrics
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

-refractory AML

Exclusion criteria

\- complete remission AML

Design outcomes

Primary

MeasureTime frameDescription
Disease status1 yearDisease status can be measured by test the of (minimal residual disease) MRD via flow cytometry one time each month until one year after HSCT. MRD\<0.0001 (complete remission), if not, relapse.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026