Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-II: Multicenter phase II clinical trial for children with non-T-ALL in intermediate risk group stratified by the minimal residual disease (MRD).

Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-II: Multicenter phase II clinical trial for children with non-T-ALL in intermediate risk group stratified by the minimal residual disease (MRD). - Multicenter phase II clinical trial for children with relapsed non-T-ALL in intermediate risk group stratified by MRD(JPLSG ALL-R08-II)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002025

Enrollment

Registered

2009-06-01

Start date

2009-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first relapsed acute lymphoblastic leukemia in children

Interventions

Patients with negative MRD at BMA3, treatment with arm A: chemotherapy Patients with positive MRD at BMA3, treatment with arm B: allogeneic stem cell transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. first relapsed non-T-ALL and S2 according to ALL-REZ BFM S classification 2. Patients have not received any treatment after relapse. 3. Be<18 years-old at initial diagnosis and be <20 years-old at the enrollment 4. Have adequate hepatic, renal and cardiac function as indicated by laboratory values written in protocol. 5. Have a ECOG Performance Status Score of 0-2. 6. Parents(or leagal guardians) must provide signed, written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with mature B-ALL, Ph positive ALL or MLL rearrangement positive ALL. 2. Down syndrome 3. Have any severe bleeding in CNS system. 4. Have an uncontrolled systemic infection. 5. Are pregnant or lactating. 6. Have received a HSCT or organ transplantation. 7. Have a congenital or aquired immunodifficiency syndrome. 8. Patients can not be treated with one or more drugs in the protocol.

Design outcomes

Primary

Measure	Time frame
3 year-event free survival rate (3y-EFS)	—

Secondary

Measure	Time frame
3 year-overall survival rate(3y-OS) Remission induction rate 3y-EFS and 3y-OS in MRD positive and negative groups Second progression free survival Incidence rates of adverse effects	—

Countries

Japan

Contacts

Public ContactAkiko Saito

Japanese Pediatric Leukemia/Lymphoma study Group Data Center

nsgdata@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026