A Phase 2 interventional study of Bexarotene in Acute Myeloid Leukemia, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 24 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Bexarotene
Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
Time frame: Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy
A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.
Time frame: Two months after 17th patient has started treatment with Bexarotene, up to 1 year.
| Milestone | Bexarotene 300mg/m2 Daily |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
| Participants | Bexarotene 300mg/m2 |
|---|---|
| Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy. | 1 |
A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.
| Participants | Bexarotene 300mg/m2 |
|---|---|
| Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bexarotene 300mg/m2 | — | 0/14 (0%) | 2/14 (14.3%) |
| Event | Bexarotene 300mg/m2 |
|---|---|
| hypothyroidismEndocrine disorders | 2/14 |
This study was completed several years ago, and the principal investigator has left the institution. Limited records are available, and despite our best efforts data are only available for 14 of the 24 enrolled participants.
| Age, Continuous(years) | Bexarotene 300mg/m2 |
|---|---|
| Median | 74 (20 to 83) |
| Sex: Female, Male(Participants) | Bexarotene 300mg/m2 |
|---|---|
| Female | 6 |
| Male | 8 |
| Region of Enrollment(participants) | Bexarotene 300mg/m2 |
|---|---|
| United States | 14 |
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine