drugset / Trial / NCT01369368
Treatment of Acute Leukemia Relapse After Allotransplantation
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
Timeline
- Start
- 2013-08
- Primary completion
- 2017-10
- Completion
- 2020-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Hydroxurea | Unknown | 1 g | — |
| Subject | Tretinoin | Small molecule | 22.5 mg/m2 | — |
| Subject | Valproic Acid | Small molecule | — | — |