DexICE therapy for refractory LBL

JRCT ID: jRCTs041180184

Registered date:29/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Refractory or recurrent lymphoblastic lymphoma.
• Date of first enrollment: 25/12/2015
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Dex ICE chemotherapy 1 (5days) -> Dex ICE chemotherapy 2 (5days) -> allogeneic SCT

Outcome(s)

• Primary Outcome: Respose rate of DexICE chemotherapy (The sum of complete and partial response)

Secondary Outcome

1) 2 years event free survival
2) 2 years overall survival
3) The rate of adverse event.
4) The rate of accomplishment of allogeneic stem cell transplantation.
5) The search of relationship between minimal disseminated disease (MDD) and prognosis during clinical cource.
6) The comprehensive genetic analysis of refractory or recurrent tumor of LBL.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 19age old
• Gender: Both

Include criteria

Satisfy all the following conditions.
1) Precursor B/T-cell lymphoblastic lymphoma (LBL) which was diagnosed through histological or cellular pathological analysis. Specimens submission is mandatory for central pathological review.
2) Recurrent or refractory (LBL) without central nervous infiltration. Criterion of recurrent or refractory is described in 3.6.2. of the protocol.
3) Primary disease onset was more than one year old and less than 18yo. Refractory or recurrent diagnosis was made less than 20yo.
4) Sufficient organs functions are mandatory, as bellows. The inspections for the criterion should be done within 14days from study registration.
Total bilirubin <= 3.0mg/dl
Serum creatinine <= 0.8 mg/dl (under 4yo)
<= 1.2 mg/dl (5 to 9yo)
<= 1.5 mg/dl (from 10yo)
There is no need of medication for arrhythmia. Electrocardiogram shows no QT prolongation. The cardiothoracic ratio is beneath 55% in chest X-ray. No heart failure sign under physiological studies.
If heart failure is suspected, an echo-cardiogram should be done. Ejection fraction >=50% and fractioning shortening >=25% is competent for the study.
If above all abnormal criterion are due to the LBL and the protocol therapy are probably made improvement of functions, the patient is competent for the study.

Exclude criteria

1) Down syndrome.
2) Central nervous infiltration.
3) The presence of Philadelphia chromosome under chromosomal or chimeric gene analysis.
4) Myelodysplastic syndrome.
5) The past history of other cancer.
6) The past history of organ transplantation including allogeneic blood stem cell transplantation.
7) The past history of congenital and acquired immunodeficiency.
8) When the doctor in charge think that the patient should be excluded for a suitable reason.

Related Information

• Primary Sponsor: Mitsui Tetsuo
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development,Yamagata University School of Medicine Pediatrics,Japan Society for the Promotion of Science(JSPS),Japanese Society for Transplantation and Cellular Therapy
• Secondary ID(s): UMIN000016346