Phase II study of the combination of Ino with mini-hyper CVD as induction therapy in childhood and AYA patients with high-risk relapsed ALL

JRCT ID: jRCTs041240091

Registered date:26/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute lymphoblastinc leukemia
• Date of first enrollment: 22/10/2024
• Target sample size: 35
• Study type: Interventional
• Intervention(s): The treatment will consist of Ino+CVD and Ino+MA. Ino+CVD consists of inotuzumab ozogamicin/dexamethasone/vincristine/cyclophosphamide. Ino+MA consists of inotuzumab ozogamicin/methotrexate/cytarabine. Time interval between Ino+CVD and Ino+MA is two weeks.

Outcome(s)

• Primary Outcome: Evaluate hematological CR rate after the trial

Secondary Outcome

Evaluate the duration over all survival , event free survival and relapse free survival
Evaluate the PCR-MRD negativity rate after the trial.
Evaluate the rate of adverse events more than NCI-CTCAE ver5.0 Grade 3
Evaluate the duration over all survival , event free survival and relapse free survival (By age: children and AYA)
Evaluate the PCR-MRD negativity rate after the trial (By age: children and AYA)
Evaluate the cumulative incidence of VOD/SOS after the trial

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 25age old
• Gender: Both

Include criteria

(1) High risk (early and very early) initial relapsed B precursor ALL (including pre-B ALL)
(2) Patients aged under 25 years at repalse
(3) Patients with CD22 positive (CD22 >=20% of lymphoblasts using flow cytometry)
(4) Written informed consent was obtained from the patients and their legal representatives.
(5) Patients with relapsed ALL do not participate another clinical trial.
(6) Patients who registered JPLSG-CHM-14 and have JPLSG number
(7) Patietns who registered ALL-R23

Exclude criteria

(1) Patients with isolated extramedullary relapse
(2) Patients who are intolerable this trial
(3) Patients who had another malignant disease
(4) Patients who received prior chemotherapy for relapsed ALL within 2 weeks of study enrollment after diagnosis of relapse (Minor prior therapies (steroids and intraspinal injection) are allowed) (Patients who relapsed during initial treatment are also allowed)
(5) Patients with history of Ino use
(6) Patients who received irradiation within 2 weeks
(7) Patients who have over Grade 2 acute GVHD and chronic GVHD involved immunosuppresive therapy
(8) Patients who have drug allergy in this trial
(9) Uncontrolled seisure despite of using anti seizure drug
(10) Patients who have any clinical test value abnormalities below
- Patients with liver dysfunction ( bilirubin >= 1.5 times the upper limit of the normal / aspartate transaminase or alanine transaminase >= 5 times the upper limit of the normal).
-Patients with kidney dysfunction (Creatinin clearance or estimated GFR less than 30 ml/min/1.73m2)
(11) Patients with active hepatitis (hepatitis B, C viruses and HIV)
(12) Pregnant or breast feeding women

Related Information

• Primary Sponsor: Yamamoto Shohei
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development