JPRN-jRCTs041180184
Active, not recruiting
Phase 2
A phase 2, multi-centre study to evaluate the efficacy and safety of Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma - JPLSG ALB-R13
Mitsui Tetsuo0 sites24 target enrollmentMarch 29, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mitsui Tetsuo
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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