A study of gemtuzumab ozogamicin in combination with G-CSF after CAG or MEC (CA-G-GO therapy or MEC-G-GO therapy) for relapsed or refractory acute myeloid leukemia.

A study of gemtuzumab ozogamicin in combination with G-CSF after CAG or MEC (CA-G-GO therapy or MEC-G-GO therapy) for relapsed or refractory acute myeloid leukemia. - Phase II study of CA-G-GO or MEC-G-GO therapy for relapsed or refractory acute myeloid leukemia.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027522

Enrollment

Registered

2017-05-29

Start date

2007-12-21

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 Myeloid Leukemia

Interventions

(CAG for aged 65 years or older) After CAG therapy (cytarabine 10 mg/square meter/12h, sc, day1-10, aclarubicin 14 mg/square meter, div, day1-4, filgrastim 50 microgram/square meter, sc, day1-10), th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. CD33-positive AML with relapsed or refractory to induction therapy (except for APL) 2. written informed consent 3.PS 0-2 (ECOG) 4. no severe organ dysfunction 5. serum bilirubin is 2.0 mg/dL or less 6. serum creatinine is 1.5 mg/dL or less

Exclusion criteria

Exclusion criteria: 1. Pregnant and/or lactating woman 2. History of hematopoietic stem cell transplantation 3. History of interstitial pneumonitis or ARDS 4. History of administration of GO 5. Uncontrolled infection 6. History of veno-occlusive disease 7. History of cardiac dysfunction induced by GO 8. Positive for HBV, HCV and HIV 9. MDS or AML derived from MDS 10. If physicians disagree to attend this study

Design outcomes

Primary

Measure	Time frame
Rate of complete remission	—

Secondary

Measure	Time frame
Safety profiles and grade, overall survival, event-free survival, disease-free survival, cytokine profiles and WT-1 mRNA	—

Countries

Japan

Contacts

Public ContactHiroshi Matsuoka

Wakayama Medical University Department of Hematology

ketunai@wakayama-med.ac.jp+81-73-441-0665

Outcome results

None listed

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