Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16).

Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16). - Phase 2 study of induction and early consolidation therapy for ALL in children (TCCSG ALL L04-16).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001413

Enrollment

300

Registered

2008-10-05

Start date

2004-12-01

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

Acute Lymphoblastic Leukemia

Interventions

For standard and intermediate risk patients

Induction therapy-A (Week 1-6): PSL, VCR, THP-ADR, L-ASP, MTX, Ara-C, HDC. Consolidation therapy-A for standard and intermediate risk patients (Week 8-10): 6MP, Ara-C, CPM, MTX, HDC. For high risk

Induction therapy-B (Week 1-6): PSL, VCR, THP-ADR,DNR, CPA, L-ASP, MTX, Ara-C, HDC. Early Consolidation therapy-B (Week 8): DEX, MTX, CPA, Ara-C, L-ASP, HDC.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Previously untreated ALL, (2) Age between 1 and 18 years, (3) Karnofsky Performance status score >50, (5) Written informed consent to participate the trial.

Exclusion criteria

Exclusion criteria: (1)Symptomatic intracranial hemorrhage (2) Uncontroled infection, (3) Double cancer, Secondary leukemia, (4) Down syndrome, (5) Pregnant, lactating woman, (6) Inadequate functioning of the liver (ALT>200 and serum total bilirubin level > 1.5 mg/dL), kidneys (serum creatinine level >= 1.5 mg/dL), (7) cardiac dysfunction, pulmonary dysfunction

Design outcomes

Primary

Measure	Time frame
The rate of complete remission at the completion of early consolidation.	—

Secondary

Measure	Time frame
1.The complete remission induction rate 2.The frequency of therapy toxicity	—

Countries

Japan

Contacts

Public ContactAkira Ohara

Toho University Omori Hospital, Dep.of Transfusion

aohara@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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