Trial Outcomes & Findings for Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukemia (NCT NCT02730195)

Last Updated: 2019-01-09

Results Overview

The AE incidence will be described. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. AEs will be assessed through scheduled assessments and subject reported diaries.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to 30 days after the end of treatment

Results posted on

2019-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone & TKI Therapy Patients receive pioglitazone PO once a day (QD) on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pioglitazone & TKI Therapy Patients receive pioglitazone PO once a day (QD) on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone & TKI Therapy n=9 Participants Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Age, Customized 30-39 years old	1 Participants n=99 Participants
Age, Customized 40-49 years old	2 Participants n=99 Participants
Age, Customized 50-59 years old	1 Participants n=99 Participants
Age, Customized 60-69 years old	4 Participants n=99 Participants
Age, Customized 70-79 years old	1 Participants n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	9 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 30 days after the end of treatment

Outcome measures

Outcome measures
Measure	Pioglitazone & TKI Therapy n=9 Participants Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03 Number of Grade 1 Events	41 events
Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03 Number of Grade 2 Events	0 events
Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03 Number of Grade 3 Events	0 events
Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03 Number of Grade 4 Events	0 events
Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03 Number of Grade 5 Events	0 events

PRIMARY outcome

Timeframe: Up to 6 months

The proportion of subjects that has reappearance of BCR-ABL1 will be described. Descriptive statistics that will summarize the changes in BCR-ABL1 testing over time will be presented. Subgroup analyses will be performed by baseline potential prognostic factors. Subgroups will include: age, gender, race, underlying diagnosis, and other disease-related prognostic factors (disease status).

Outcome measures

Outcome measures
Measure	Pioglitazone & TKI Therapy n=9 Participants Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Proportion of Subjects Who Achieve and Maintain Major Molecular Response (MMR) Following a Second Discontinuation of TKI Using Blood Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) for Breakpoint Cluster Region-Abelson1 (BCR-ABL1)	8 Participants

SECONDARY outcome

Timeframe: Up to 3 years

The proportion of subjects that has reappearance of BCR-ABL1 will be described. Descriptive statistics that will summarize the changes in BCR-ABL1 testing over time will be presented. Loss of MMR is defined as a BCR-ABL1 \> 0.1% by qRT-PCR confirmed within a week and associated with a rise in the titer on a confirmatory test obtained 4 weeks later (European Leukemia Net definition). Subgroup analyses will be performed by baseline potential prognostic factors. Subgroups will include: age, gender, race, underlying diagnosis, and other disease-related prognostic factors (disease status).

Outcome measures

Outcome measures
Measure	Pioglitazone & TKI Therapy n=9 Participants Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
Proportion of Subjects Who Lose MMR Following Discontinuation of Pioglitazone and TKI Using Blood qRT-PCR for BCR-ABL1	7 Participants

Adverse Events

Pioglitazone & TKI Therapy

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pioglitazone & TKI Therapy n=9 participants at risk Patients receive pioglitazone PO QD on days 1-28. Patients also start or continue the same tyrosine kinase inhibitor (TKI) therapy at the pre-discontinuation doses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Pioglitazone: Given PO Tyrosine Kinase Inhibitor (TKI): Given TKI therapy
General disorders Edema limbs	55.6% 5/9 • Up to 30 days after the end of treatment
General disorders Fatigue	22.2% 2/9 • Up to 30 days after the end of treatment
General disorders Edema face	11.1% 1/9 • Up to 30 days after the end of treatment
General disorders Night sweats	11.1% 1/9 • Up to 30 days after the end of treatment
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Up to 30 days after the end of treatment
Gastrointestinal disorders Nausea	22.2% 2/9 • Up to 30 days after the end of treatment
Gastrointestinal disorders Constipation	11.1% 1/9 • Up to 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Up to 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Muscle cramps	11.1% 1/9 • Up to 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Up to 30 days after the end of treatment
Nervous system disorders Headache	11.1% 1/9 • Up to 30 days after the end of treatment
Nervous system disorders Paresthesia	11.1% 1/9 • Up to 30 days after the end of treatment
Nervous system disorders Peripheral sensory neuropathy	11.1% 1/9 • Up to 30 days after the end of treatment
Renal and urinary disorders Urinary frequency	33.3% 3/9 • Up to 30 days after the end of treatment
Renal and urinary disorders Urine discoloration	11.1% 1/9 • Up to 30 days after the end of treatment
Investigations Creatinine increased	11.1% 1/9 • Up to 30 days after the end of treatment
Investigations Platelet count decreased	11.1% 1/9 • Up to 30 days after the end of treatment
Investigations White blood cell decreased	11.1% 1/9 • Up to 30 days after the end of treatment
Reproductive system and breast disorders Irregular menstruation	11.1% 1/9 • Up to 30 days after the end of treatment
Reproductive system and breast disorders Nipple tenderness	11.1% 1/9 • Up to 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Up to 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	11.1% 1/9 • Up to 30 days after the end of treatment
Skin and subcutaneous tissue disorders Alopecia	11.1% 1/9 • Up to 30 days after the end of treatment
Skin and subcutaneous tissue disorders Bruising	11.1% 1/9 • Up to 30 days after the end of treatment
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Up to 30 days after the end of treatment
Cardiac disorders Palpitations	11.1% 1/9 • Up to 30 days after the end of treatment
Ear and labyrinth disorders Vertigo	11.1% 1/9 • Up to 30 days after the end of treatment

Additional Information

William Blum, MD

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place