Single-group, open-label study of allogeneic hematopoietic stem cell transplantation using reduced-intensity conditioning regimen for relapsed or refractory childhood anaplastic large cell-lymphoma

JRCT ID: jRCTs041190066

Registered date:06/09/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anaplastic large cell lymphoma (ALCL)
• Date of first enrollment: 27/02/2020
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Fludarabin 30mg/m2 for 5 days, melphalan 70mg/m2 for 2 days, and 4 Gy of total body irradiation are administered as the reduced-intensity conditioning for allogeneic stem cell transplantation.

Outcome(s)

• Primary Outcome: Post-transplant 1 year event-free survival rate

Secondary Outcome

1) Overall survival duration (maximum 2 years)
2) Event-free survival duration (maximum 2 years)
3) Cumulative incidence of relapse rate (maximum 2 years)
4) Neutrophil engraftment
5) Treatment-related death
6) Acute GVHD: incidence and severity
7) Chronic GVHD: incidence and severity
8) Donor lymphocyte infusion: incidence, infusion cell count, and reason
9) Incidence of second transplantation
10) Chimeric analysis (at post-transplant day 30 and day100)
11) Toxicity of conditioning regimen which occurs during the period from beginning of conditioning regimen to day +28 post-transplant
12) Number of days with pyrexia (38 degree and higher) until post-transplant day 100
13) Adverse effect at post-transplant day 100, 1 year, and 2 years

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 20age old
• Gender: Both

Include criteria

(1) Anaplastic large-cell lymphoma patients aged under 20 years at the registration
(2) Induction failure patients for first line chemotherapy, or patients have a relapse after chemotherapy or autologous hematopoietic stem cell transplantation
(3) Patients who have the indication of hematopoietic stem cell transplantation
(4) ECOG Performance status 0 - 2
(5) Satisfy all following conditions within 21 days of the registration;
(5-a) Cardiac function: EF is 50% or higher without uncontrolled heart failure
(5-b) Pulmonary function: FEV1.0% is 50% or higher and %VC is 50% or higher, or SpO2 is 95% or higher without oxygen administration for the patients who could not receive spirometry
(5-c) Liver function: AST / ALT are less than 5 x ULN (CTCAE grade 2 or less) and T.Bil is less than 3 x ULN (CTCAE grade 2 or less)
(5-d) Renal function: serum creatinine value is less than 2 x ULN without uncontrolled renal failure
(6) Patients enrolled for JPLSG's forward vision study (JPLSG-CHM-14)
(7) Patients who agreed in writing (including ascent) from the substitute, or substitute and patient for this study participation

Exclude criteria

(1) Patients with CNS involvement
(2) Patients who received previous allogeneic hematopoietic transplantation or organ transplantation
(3) Patients who have an uncontrolled infection
(4) Patients with congenital disease or psychiatric disorders that interfere with study treatment
(5) Patients who have other malignancies
(6) There is a history of hypersensitivity in drugs used for pretransplant treatment and prevention of acute GVHD
(7) Patients who are pregnant or possibly pregnant
(8) Patients who are considered as to be inappropriate by the doctor in charge

Related Information

• Primary Sponsor: Fukano Reiji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Yamaguchi University Hospital