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CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.

CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia. - CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia(CA-GO2015).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021553
Enrollment
20
Registered
2016-03-21
Start date
2016-03-21
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

CD33 positive, primary refractory or 1st relapse AML without APL.

Interventions

(CA-GO therapy) Ara-C : 10mg/m^2/12h, sc, day1 - 14 ACR : 65 -69 years : 14mg/m^2/day 70 - years : 10mg/m^2/day 1 hour, div, day1 - 4(, 8 - 10) GO(gemtuzumab ozogamicin) : 3mg/m^2/day, 2 hour

Sponsors

Dokkyo medical university hospital, Hematology and Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)CD33 positive, primary refractory or 1st relapse AML(non APL). (2)Patient who has the registrar's written consent. (3)PS 0, 1, 2 (4)T-B <2.0mg/dl (5)Cre <2.0mg/dl (6)PaO2 >60Torr or SpO2 >93% (7)normal ECG and normal UCG(EF >50%) (8)WBC <30,000 x10^6/L

Exclusion criteria

Exclusion criteria: (1)active other malignancy. (2)cardiac infarction in one year. (3)renal failure (4)uncontrolable diabetes (5)uncontrolable infection (6)liver cirrhosis (7)severe mental disorders (8)pregnancy (9)HIV positive (10)allergy of GO (11)recieved therapy include GO (12)after SCT or solid organ transplantation

Design outcomes

Primary

MeasureTime frame
CR rate on day43.

Secondary

MeasureTime frame
Rate of adverse events, OS, EFS, DFS, CR rate after 2nd CA-GO therapy, karyotype, WT1 mRNA, surface marker.

Countries

Japan

Contacts

Public ContactWataru TAKAHASHI

Dokkyo medical university hospital Hematology and Oncology

twataru@dokkyomed.ac.jp+81-282-86-1111

Outcome results

None listed

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