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

NCT ID: NCT03654703

Last Updated: 2018-08-31

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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 .

Conditions

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Hematopoietic System--Cancer

Keywords

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HSCT, AML， R-AML

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cyclophophamide

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

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

cyclophophamide

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

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

cyclophophamide

Interventions

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Cyclophosphamide

cyclophophamide

Intervention Type DRUG

Other Intervention Names

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Cy

Eligibility Criteria

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Inclusion Criteria

-refractory AML

Exclusion Criteria

\- complete remission AML
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Research Institute of Pediatrics

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yan Yue

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jia Y Qin, MD

Role: STUDY_DIRECTOR

Hematology and oncology

Locations

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Yan Yue

Beijing, Chaoyang District, China

Site Status

Countries

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China

References

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Sugita J, Kagaya Y, Miyamoto T, Shibasaki Y, Nagafuji K, Ota S, Furukawa T, Nara M, Akashi K, Taniguchi S, Harada M, Matsuo K, Teshima T; Japan Study Group for Cell Therapy and Transplantation (JSCT). Myeloablative and reduced-intensity conditioning in HLA-haploidentical peripheral blood stem cell transplantation using post-transplant cyclophosphamide. Bone Marrow Transplant. 2019 Mar;54(3):432-441. doi: 10.1038/s41409-018-0279-1. Epub 2018 Aug 7.

Reference Type RESULT
PMID: 30087460 (View on PubMed)

Marani C, Raiola AM, Morbelli S, Dominietto A, Ferrarazzo G, Avenoso D, Giannoni L, Varaldo R, Gualandi F, Grazia D, Lamparelli T, Bregante S, Van Lint MT, Ibatici A, Bovis F, Lemoli RM, Gobbi M, Bacigalupo A, Angelucci E. Haploidentical Transplants with Post-Transplant Cyclophosphamide for Relapsed or Refractory Hodgkin Lymphoma: The Role of Comorbidity Index and Pretransplant Positron Emission Tomography. Biol Blood Marrow Transplant. 2018 Dec;24(12):2501-2508. doi: 10.1016/j.bbmt.2018.07.025. Epub 2018 Jul 21.

Reference Type RESULT
PMID: 30041010 (View on PubMed)

Law AD, Salas MQ, Lam W, Michelis FV, Thyagu S, Kim DDH, Lipton JH, Kumar R, Messner H, Viswabandya A. Reduced-Intensity Conditioning and Dual T Lymphocyte Suppression with Antithymocyte Globulin and Post-Transplant Cyclophosphamide as Graft-versus-Host Disease Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplants for Hematological Malignancies. Biol Blood Marrow Transplant. 2018 Nov;24(11):2259-2264. doi: 10.1016/j.bbmt.2018.07.008. Epub 2018 Aug 7.

Reference Type RESULT
PMID: 30009980 (View on PubMed)

Other Identifiers

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CIP-2015-AML

Identifier Type: -

Identifier Source: org_study_id