Clinical trial · Interventional
Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65
A Phase II Study Examining the Use of Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed Acute Myelogenous Leukemia (AML) in Elderly Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated early due to low patient accrual.
Summary
Brief summary (as posted)
The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia will go into complete remission (meaning the leukemia is completely gone), and to find out how long it stays away. The drugs used in this project are FDA approved and commercially available.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Cholecalciferol | Drug | — | UNRESOLVED |
| Deferasirox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug Treatment
- description
- Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV
- interventionNames
- Drug: Deferasirox
- Drug: Cholecalciferol
- Drug: Azacitidine
Primary outcomes (1)
- measure
- Complete Remission Rate
- timeFrame
- up to 5 years
- description
- The Complete Remission Rate for all evaluable patients will be reported for the following treatment: azacitadine, vitamin D, and deferasirox (Exjade). The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact confidence interval.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * 65 or older (must have reached 65th birthday) * Morphologically confirmed diagnosis of AML, excluding AML-M3 * Must have a Zubrod performance status of 0-3 Exclusion Criteria: * Patients with known HIV infection are excluded. If HIV infection is suspected based on clinical condition, testing may be performed at the discretion of treatment team, but is not mandated prior to enrollment. * Patients with central nervous system involvement by AML are excluded * Patients with history of an active cancer (except basal cell and squamous cell cancers of the skin) within the previous 2 years are excluded
References
Publications (0)
Data not yet available