The novel induction therapy by low-dose cytarabine and blinatumomab for relapse/refractory ALL

JRCT ID: jRCTs041210107

Registered date:24/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: CD19-positive B cell precursor acute lymphoblastic leukemia
• Date of first enrollment: 28/01/2022
• Target sample size: 45
• Study type: Interventional
• Intervention(s): The induction chemotherapy of low-dose, continous cytarabine followed by 2 cycles of blinatumomab against childhood relapsed/refractory, CD19-positive acute lymphoblastic leukemia

Outcome(s)

• Primary Outcome: The rate of hematological complete remission after 2nd cycle of blinatumomab

Secondary Outcome

1. event-free or overall survival rate at 6 or 12 months after the start of the protocol therapy
2. non-relapse survival rate at 6 or 12 months after the start of the protocol therapy in patients who achieve CR after the therapy
3. MRD after 2nd cycle of blinatumomab
4. Hematological PR or CR rate after 1st cycle of blinatumomab
5. Adverse events during the protocol therapy
6. Hematological CR rate and MRD after 2nd cycle of blinatumomab according to disease status (primary refractiory disease, 1st relapse, refractory disease after 1st relapse, 2nd relapse, relapse after SCT)
7. Hematological CR rate and adverse events in patients with or without underlying conditions (Down syndrome or othe congenital diseases)
8. Hematological CR rate and adverse events in patients with or without organ dysfunction (low cardiac ejection fraction, low renal function, abnormal liver function)
9. Correlation between hematological response (CR + PR) rate and bone marrow or peripheral blast counts after the study enrollment or just before blinatumomab.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Goto Hiroaki
• Source(s) of Monetary Support: Amgen K.K.,Japan Agency for Medical Research and Development