DexICE therapy for refractory LB

Phase 2

• Conditions: Refractory or recurrent lymphoblastic lymphoma.; Non-Hodgkin lymphoma; 0054198

• Registration Number: JPRN-jRCTs041180184
• Lead Sponsor: Mitsui Tetsuo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified