Trials / Terminated
TerminatedNCT04093505
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)
Randomized Phase-III Study to Compare Two Schedules of Gemtuzumab Ozogamicin as Adjunct to Intensive Induction Therapy and to Compare Intensive Postremission Therapy Double Blinded With or Without Glasdegib in Older Patients With Newly Diagnosed AML
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University Hospital Heidelberg · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The study is a randomized phase III trial with a 2x2 factorial design with measurable residual disease and event-free survival as primary endpoints, respectively. Patients are upfront randomized for the two induction schedules (Gemtuzumab Ozogamicin (GO)-147 versus GO-1; ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to consolidation therapy and as single agent 6 months maintenance therapy. Chemotherapy backbone for induction therapy is standard 7+3 with cytarabine 200mg/m² continuously day 1 to day 7, daunorubicin 60mg/m² days 1, 2 and 3 and for consolidation therapy intermediate dose cytarabine (1g/m², bi-daily, days 1,2,3). The trial is designed to gain evidence of anti-leukemic activity of GO and Glasdegib in older patients with newly diagnosed acute myeloid leukemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemtuzumab Ozogamicin 147 | Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on days 1,4 and 7 |
| DRUG | Gemtuzumab Ozogamicin 1 | Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on day 1 |
| DRUG | Glasdegib | Consolidation \& Maintenance therapy Glasdegib 100mg on days 4 to 27 |
| DRUG | Placebo Oral Tablet | Consolidation \& Maintenance therapy Placebo 100mg on days 4 to 27 |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-06-15
- Completion
- 2022-06-23
- First posted
- 2019-09-18
- Last updated
- 2022-07-01
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04093505. Inclusion in this directory is not an endorsement.