The novel induction therapy by low-dose cytarabine and blinatumomab for relapse/refractory A
- Conditions
- CD19-positive B cell precursor acute lymphoblastic leukemiachildren, relapsed, refractory, acute lymphoblastic leukemiaD007938
- Registration Number
- JPRN-jRCTs041210107
- Lead Sponsor
- Goto Hiroaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Subjects who meet all inclusion criteria can be enrolled to the study.
1) Patients who were diagnosed to have B cell precursor-ALL (including Pre-B ALL) when they were at 18-year-old or younger age.
2) either of disease status of;
1. 1st or later bone marrow relapse including relapse after SCT (in patients with 1st relapse ALL, only when phsicians consider that intensive cytotoxic chemotherapy is inappropriate because of physical conditions or other reasons.)
2. refractory ALL (patients with primary or relapsed ALL who cannot achieve CR after intensive chemotherapy)
3) Patients with informed consent or with guardian's informed consent
4) Patients who have registered into the study of Classification of newly diagnosed Hematological Malignancy - 2014 (CHM-14) of Japanese Pediatric Leukemia/Lymphoma Study Group and have the JPLSG number
Subjects who have either f these criteria cannot enroll to the study.
1)CD19-negative ALL (20% or lower blasts are positive for CD19 by FCM)
2)CNS or testis disease at the study enrollment
3)Isolated extramedullary relapse
4)Patients who have other cancer
5)Refractory disease after blinatumomab
6)Chemotherapy except for glucocorticoid as a single agent or intratechal chemotherapy within 2 weeks
7)Radiation therapy within 2 weeks
8)Drug allergy for cytarabine or blinatumomab
9)Uncontrolled convulsion
10)Past or present autoimmune disease involving CNS disease
11)Grade 2 or higher grade acute GVHD or chronic GVHD requiring systemic therapy
12)Laboratory data abnormalities (either of)
1.AST and/or ALT; 5 or more times higher than normal upper limit
2.Total bilirubin; 1.5 or more times higher than normal upper limit
3.eGFR; lower than 30 ml/min/1.73m2
13)HIV, HBV, or HCV infection
14)Pregnant or lactating woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of hematological complete remission after 2nd cycle of blinatumomab
- Secondary Outcome Measures
Name Time Method