Multicenter, single-group, open-label study of T-cell-replete haploidentical stem cell transplantation for relapsed and refractory childhood acute leukemia with low dose anti-thymocyte immunoglobuli

Phase 2

• Conditions: Acute leukemia

• Registration Number: JPRN-jRCTs041190061
• Lead Sponsor: Kobayashi Shogo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

(1) Childhood Acute Leukemia Patient at the Time of Initial Age 0 to under 18 and under the age of 20 when registering
(2) It is a relapsed / refractory case having one of the following stages
(2-1) non-remission for the first two or more different induction therapies
(2-2) extremely early and early relapsed ALL (corresponding to BFM recurrence risk classification S3, 4) within 6 months after treatment, during treatment,
(2-3) Recurrence AML less than 1 year after treatment start
(2-4) Relapse after transplantation (including autologous, syngeneic, allogeneic transplantation, haploidentical transplantation)
(2-5) Second recurrence or more
(3) HLA haploidentical transplant donors are present
(4) ECOG Performance status (PS) 0 - 3
(5) Patients enrolled for JPLSG's forward vision study (JPLSG-CHM-14)
(6) Patients who agreed in writing (including ascent) from the principal and / or substitute for this study participation

Exclusion Criteria

(1) Relapsed leukemia patients with extramedullary invasion only (eg central nervous invasion only)
(2) Ph1 positive acute leukemia patients who have never received treatment with tyrosine kinase inhibitor (TKI)
(3) There is a merger of congenital chromosomal abnormality syndrome such as Down's syndrome
(4) There is an organ failure that interferes with examination treatment
(4-1) Renal function: serum creatinine value is less than twice as high as the age-specific upper limit
(4-2) cardiac function: heart failure requiring treatment and arrhythmia. Or less than 50% EF or less than 28% SF
(4-3) Liver function: AST / ALT is at least 5 times higher than age-specific reference value upper limit (CTCAE grade 3 or more) and T-Bil is at least 3 times higher than age-specific reference value upper limit (CTCAE grade 3 or more)
(4-4) Respiratory function: There is a breathing disorder that is less than 95% SpO 2 in room air or requires oxygen administration
(5) Patients who have an uncontrolled infection (including active tuberculosis, HIV infection)
(6) Patients who are pregnant or possibility of pregnancy
(7) Have congenital or psychiatric disorders that interfere with study treatment
(8) Secondary cancers other than recurrent hematopoietic tumors are merged
(9) Patients received two or more myeloablative conditioning allogeneic transplantation in the past
(10) Secondary leukemia
(11) myeloid NK cell leukemia
(12) There is a history of hypersensitivity in drugs used for pretransplant treatment and prevention of acute GVHD
(13) Any inappropriate status judged by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified