A Phase 2 interventional study of Deferasirox and Cholecalciferol in Acute Myeloid Leukemia, sponsored by Elizabeth Henry. Terminated at 1 site in United States. Open to participants aged 65 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Elizabeth Henry · Phase 2, Interventional, and Treatment
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.
The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard therapies for AML often have significant toxicity and are poorly tolerated by this patient population. Treatment strategies for elderly patients with AML are limited. In those patients who do achieve complete remission, duration of remission tends to be short. Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there is need for safer and more effective therapies for elderly patients with AML. This trial is a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in patients 65 years or older with newly diagnosed AML who are not fit for standard induction chemotherapy or hematopoietic stem-cell transplantation.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →This is the only study on the registry with Elizabeth Henry as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Deferasirox · Drug: Cholecalciferol · Drug: Azacitidine
Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO
Also known as: Exjade
Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO
Also known as: Vitamin D
Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Also known as: Vidaza
Complete Remission Rate
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.
Time frame: up to 5 years
Number of Patients With Adverse Events
Characterization of the safety of an induction regimen of azacitidine in combination with vitamin D and deferasirox (Exjade). The proportion of patients experiencing severe adverse events, and the number of patients experiencing severe adverse events probably or definitely related to treatment will be determined. Adverse events will be tabulated by category and graded by NCI CTCAE version 4.0
Time frame: up to 5 years
Survival
The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.
Time frame: up to 5 years
Duration of Remission
The length of time for remission after achieving complete remission
Time frame: up to 5 years
| Milestone | Drug Treatment |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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.
No measurements were reported for this outcome.
Characterization of the safety of an induction regimen of azacitidine in combination with vitamin D and deferasirox (Exjade). The proportion of patients experiencing severe adverse events, and the number of patients experiencing severe adverse events probably or definitely related to treatment will be determined. Adverse events will be tabulated by category and graded by NCI CTCAE version 4.0
No measurements were reported for this outcome.
The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.
No measurements were reported for this outcome.
The length of time for remission after achieving complete remission
No measurements were reported for this outcome.
Collected over Adverse event data were collected for 45 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug Treatment | 2/4 (50%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Drug Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Drug Treatment |
|---|---|
| Female | 3 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Drug Treatment |
|---|---|
| White | 4 |
| Region of Enrollment(participants) | Drug Treatment |
|---|---|
| United States | 4 |
Plan to share: No — There is no plan to share individuals participant data.
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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