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

Sponsor
Capital Research Institute of Pediatrics (Other)
Overall Status
Unknown status
CT.gov ID
NCT03654703
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cyclophophamide

Cyclophosphamide 50mg/kg/day on day+3，+4 after HSCT. Intervention: drugs:Cyclophosphamide.

Drug: Cyclophosphamide
cyclophophamide
Other Names:
  • Cy

    		•
    Experimental: Placebo

    5% GLS（Placebo) 50ml/day on day+3，+4 after HSCT. Intervention: drugs: Placebo other name: placebo (for Cyclophosphamide) 5%Glugose in water 50ml or normal saline

    Drug: Cyclophosphamide
    cyclophophamide
    Other Names:
  • Cy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease status [1 year]

      Disease 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -refractory AML

    Exclusion Criteria:
    • complete remission AML

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yan Yue Beijing Chaoyang District China 100020

    Sponsors and Collaborators

    • Capital Research Institute of Pediatrics

    Investigators

    • Study Director: Jia Y Qin, MD, Hematology and oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yan Yue, MD,PhD, Capital Research Institute of Pediatrics
    ClinicalTrials.gov Identifier:
    NCT03654703
    Other Study ID Numbers:
    • CIP-2015-AML
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Aug 31, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yan Yue, MD,PhD, Capital Research Institute of Pediatrics
    HSCT, AML， R-AML
    Additional relevant MeSH terms:
    Cyclophosphamide

    Study Results

    No Results Posted as of Aug 31, 2018