Trial · NCT01650805

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

NCT01650805, Phase 3, Terminated, Ariad Pharmaceuticals; results first posted 2014-10-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC). Trials, record NCT01650805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01650805

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
NCT number: NCT01650805
Status: Terminated
Phases: Phase 3
Enrollment: 307 participants, actual
Lead sponsor: Ariad Pharmaceuticals
Conditions: Chronic Myeloid Leukemia
Interventions: ponatinib, imatinib (Gleevec/ Glivec)
First posted: 2012-07-26
Last updated: 2014-11-17
Results first posted: 2014-10-21
Limitations and caveats: Trial was discontinued early.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Major Molecular Response (MMR) Rate at 12 Months	12 months after first dose	A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.
Secondary	MMR Rate	5 years after first dose	To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
Secondary	<10% BCR-ABL^IS Rate	3 months after first dose	To compare the proportion of patients achieving a ratio of \<10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (\<10% BCR-ABL\^IS), in patients administered ponatinib versus those administered imatinib
Secondary	Complete Cytogenetic Response (CCyR) Rate	12 months after first dose	The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.
Secondary	Progression-free Survival	Up to 8 years after the last patient's first dose	To compare, according to treatment with ponatinib versus imatinib, progression-free survival
Secondary	Overall Survival	Up to 8 years after the last patient's first dose	To compare, according to treatment with ponatinib versus imatinib, overall survival

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Major Molecular Response (MMR) Rate at 12 Months	12 months after first dose	Patients with 12 month assessment (due to early termination of the study, none of the endpoints could be evaluated as planned).	participants	NUMBER
SECONDARY	MMR Rate	5 years after first dose
SECONDARY	<10% BCR-ABL^IS Rate	3 months after first dose	Patients with 3 month assessment	participants	NUMBER
SECONDARY	Complete Cytogenetic Response (CCyR) Rate	12 months after first dose	Patients with 12 month assessment	participants	NUMBER
SECONDARY	Progression-free Survival	Up to 8 years after the last patient's first dose
SECONDARY	Overall Survival	Up to 8 years after the last patient's first dose

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Major Molecular Response (MMR) Rate at 12 Months	Ponatinib	8	participants
Major Molecular Response (MMR) Rate at 12 Months	Imatinib	5	participants
<10% BCR-ABL^IS Rate	Ponatinib	103	participants
<10% BCR-ABL^IS Rate	Imatinib	77	participants
Complete Cytogenetic Response (CCyR) Rate	Ponatinib	5	participants
Complete Cytogenetic Response (CCyR) Rate	Imatinib	6	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ponatinib	155
Overall Study	STARTED	Imatinib	152
Overall Study	COMPLETED	Ponatinib	154
Overall Study	COMPLETED	Imatinib	152
Overall Study	NOT COMPLETED	Ponatinib	1
Overall Study	NOT COMPLETED	Imatinib	0

Source ClinicalTrials.gov

Adverse events260

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ANAEMIA	Blood and lymphatic system disorders	Ponatinib 45 mg	13	154	15
other	ANAEMIA	Blood and lymphatic system disorders	Imatinib 400 mg	12	152	14
other	DRY EYE	Eye disorders	Ponatinib 45 mg	10	154	10
other	DRY EYE	Eye disorders	Imatinib 400 mg	3	152	3
other	EYELID OEDEMA	Eye disorders	Ponatinib 45 mg	1	154	1
other	EYELID OEDEMA	Eye disorders	Imatinib 400 mg	13	152	13
other	PERIORBITAL OEDEMA	Eye disorders	Ponatinib 45 mg	1	154	1
other	PERIORBITAL OEDEMA	Eye disorders	Imatinib 400 mg	33	152	37
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Ponatinib 45 mg	10	154	11
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Imatinib 400 mg	5	152	5

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ponatinib 45 mg
Total, all-cause mortality	Imatinib 400 mg
Total, other adverse events	Ponatinib 45 mg	145	154
Total, other adverse events	Imatinib 400 mg	144	152
Total, serious adverse events	Ponatinib 45 mg	49	154
Total, serious adverse events	Imatinib 400 mg	13	152

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27083332	DERIVED	PubMed
34699069	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ponatinib vs Imatinib: <10% BCR-ABL^IS Rate	Trial comparisons
Ponatinib vs Imatinib: Complete Cytogenetic Response (CCyR) Rate	Trial comparisons
Ponatinib vs Imatinib: Major Molecular Response (MMR) Rate at 12 Months	Trial comparisons
Ponatinib 45 mg vs Imatinib 400 mg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01650805

GET https://conductscience.org/api/trials/v1/NCT01650805/events?page=2

API reference For AI assistants