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

Hematopoietic System--Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03654703
• Other study ID #: CIP-2015-AML
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 1, 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2018
• Source: Capital Research Institute of Pediatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

-refractory AML

Exclusion Criteria:

• complete remission AML

Related Conditions & MeSH terms

• Hematopoietic System--Cancer

Intervention

Drug:
• Cyclophosphamide
cyclophophamide

Locations

Country	Name	City	State
China	Yan Yue	Beijing	Chaoyang District

Sponsors (1)

Lead Sponsor	Collaborator
Capital Research Institute of Pediatrics

Country where clinical trial is conducted

China, 

References & Publications (3)

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 D — View Citation

Marani C, Raiola AM, Morbelli S, Dominietto A, Ferrarazzo G, Avenoso D, Giannoni L, Varaldo R, Gualandi F, Grazia CD, Lamparelli T, Bregante S, Van Lint MT, Ibatici A, Bovis F, Lemoli RM, Gobbi M, Bacigalupo A, Angelucci E. Haploientical Transplants with — View Citation

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 HL — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease status	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.	1 year