Phase I/II study of clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy in adult patients with refractory or relapse acute lymphoblastic leukemia (JALSG RR-ALL214)

Phase I/II study of clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy in adult patients with refractory or relapse acute lymphoblastic leukemia (JALSG RR-ALL214) - JALSG RR-ALL214

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015373

Enrollment

Registered

2014-10-20

Start date

2014-11-10

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 (ALL) which is relapsed or refractory to induction therapy (including the ph chromosome positive ALL)

Interventions

clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) ALL which is relapsed or refractory to induction therapy (including the ph chromosome positive ALL). (2) Age; above 15 to younger than 60 years old. (3) PS 0-2 (ECOG) (4) Adequate hepatic, renal, pulmonary and cardiac function. SpO2 more 94%, Creatinine clearance and more 30ml/min, serum total bilirubin and less 2.0mg/dl, ECG: WNL, (5) Written informed consent.

Exclusion criteria

Exclusion criteria: 1. CNS leukemia 2. Uncontrolled infection 3. Sever comorbidity (diabetes mellitus, infection or liver cirrhosis) 4. Complication of active malignant disease 5. Pregnant and/or lactating woman 6. Psychological disorder 7. Positive HBV, HIV infection 8. Judged to be inadequate

Design outcomes

Primary

Measure	Time frame
Phase I : tolerability, safety Phase II: CR (complete remission) rates, CRp rates	—

Secondary

Measure	Time frame
Phase I: 1) CR (complete remission) rates, CRp rate, tolerability, safety, 2) adverse event rates, 3) Overall survival, 4) reccurrence free survival time, Phase II: 1) adverse event rates, 2) Overall survival, 3) reccurrence free survival time	—

Countries

Japan

Contacts

Public ContactTakeshi Saito

The Jikei University School of Medicine Department of Clinical oncology and hematology

takexsaito@jikei.ac.jp03-3433-1111

Outcome results

None listed

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