Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.

Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia. - Phase I Study of GO+Ara-C+DNR for Relapsed or Refractory Patients with Acute Myeloid Leukemia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001141

Enrollment

Registered

2008-05-10

Start date

2006-11-01

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 Myeloid Leukemia

Interventions

Combination chemotherapy of Gemtuzumab ozogamicin+Daunorubicin+Cytarabine as induction therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.CD33-positive AML with first relapsed (CR duration>6 months) or refractory to initial induction therapy (exclusion of APL) 2.Age; above 20 to younger than 65 years old 3.PS 0-2 (ECOG) 4.More than 30 days after previous therapy 5. Adequate hepatic, renal, pulmonary and cardiac function serum bilirubin <1.5 mg/dL, serum creatinine <2.0 mg/dL,PaO2>60 mmHg or SaO2>93%, ECG: WNL 6.More than 2 months of life expectancy 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. History of MDS or MPD 2. Secondary AML related to chemotherapy or radiotherapy 3. CNS-leukemia 4. History of hematopoietic stem cell transplantation 5. Total dose of DNR >500 mg/m2 6. Pregnant and/or lactating woman 7. History of therapy with anti-CD33 monoclonal antibody 8. Complication of active malignant disease 9. Uncontrolled infection 10.Positive HBV, HCV and HIV infection 11.History of attending any phase study of new drugs. 12.If physisians disagree to attend this study

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of DNR and GO	—

Secondary

Measure	Time frame
Rates of complete remission and safety profile and grades.	—

Countries

Japan

Contacts

Public ContactNoriko Usui

The Jikei University School of Medicine(Dai-San Hospital) Department of Clinical Oncology and Hematology

usuin@jikei.ac.jp03-3480-1151

Outcome results

None listed

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