Trial Outcomes & Findings for Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (NCT NCT00615784)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Two months after 17th patient has started treatment with Bexarotene, for up to 1 year

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bexarotene 300mg/m2 Daily Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bexarotene 300mg/m2 n=14 Participants Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Age, Continuous	74 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Two months after 17th patient has started treatment with Bexarotene, for up to 1 year

Population: 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.

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

Outcome measures

Outcome measures
Measure	Bexarotene 300mg/m2 n=14 Participants 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.	1 Participants

SECONDARY outcome

Timeframe: Two months after 17th patient has started treatment with Bexarotene, up to 1 year.

Population: 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. Additionally only 5 patients had a bone marrow biopsy at 2 months.

A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.

Outcome measures

Outcome measures
Measure	Bexarotene 300mg/m2 n=5 Participants Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy	1 Participants

Adverse Events

Bexarotene 300mg/m2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bexarotene 300mg/m2 n=14 participants at risk Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Endocrine disorders hypothyroidism	14.3% 2/14 • Number of events 2

Additional Information

Harjeet Sembhi, research program director

abramsoncc, University of Pennsylvania

Phone: 215-220-9688

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place