Trial · NCT01404949

Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

NCT01404949, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2021-11-30

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy. Trials, record NCT01404949. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01404949

On this page

Trial

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

Title: Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
NCT number: NCT01404949
Status: Completed
Phases: Phase 2
Enrollment: 17 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Acute Promyelocytic Leukemia
Interventions: Tretinoin and Arsenic Trioxide
First posted: 2011-07-28
Last updated: 2021-11-30
Results first posted: 2021-11-30

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	To Determine the Rate of Molecular Remission	4 years	after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.
Secondary	Participants Who Experienced a Complete Remission	4 years	after induction with tretinoin and ATO (with idarubicin in patients with high-risk disease or who develop leukocytosis).
Secondary	To Determine the Proportion of Patients in Molecular Remission	4 years	after each course of postremission therapy.
Secondary	To Determine the Disease-free and Event-free Survival of Patients	4 years	treated with this program.
Secondary	To Determine the Toxicity of This Treatment Program	4 years	including the early death rate (within 30 days), the incidence of APL differentiation syndrome, the number and length of hospitalizations, the incidence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), and the effects of treatment on left ventricular ejection fraction (LVEF) Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.
Secondary	To Characterize the Differentiation of APL Cells During Treatment	4 years	with combined tretinoin and ATO using serial immunophenotyping studies of peripheral blood
Secondary	Explore the in Vivo Induction of Telomerase-dependent Cell Death	4 years	by ATRA (Tretinoin) and ATO (Arsenic Trioxide). Bone marrow samples will be analyzed at baseline and at the time of clinical CR for telomerase activity, telomere length and TERT expression

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Determine the Rate of Molecular Remission	4 years	Data were not collected
SECONDARY	Participants Who Experienced a Complete Remission	4 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Determine the Proportion of Patients in Molecular Remission	4 years	Data were not collected
SECONDARY	To Determine the Disease-free and Event-free Survival of Patients	4 years	Data were not collected
SECONDARY	To Determine the Toxicity of This Treatment Program	4 years	Data were not collected
SECONDARY	To Characterize the Differentiation of APL Cells During Treatment	4 years	Data were not collected
SECONDARY	Explore the in Vivo Induction of Telomerase-dependent Cell Death	4 years	Data were not collected

Source ClinicalTrials.gov

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Participants Who Experienced a Complete Remission	Tretinoin and Arsenic Trioxide		16		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Tretinoin and Arsenic Trioxide	17
Overall Study	COMPLETED	Tretinoin and Arsenic Trioxide	16
Overall Study	NOT COMPLETED	Tretinoin and Arsenic Trioxide	1

Source ClinicalTrials.gov

Adverse events91

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
other	Dry skin	Skin and subcutaneous tissue disorders	Tretinoin and Arsenic Trioxide	4	17
other	Fatigue	General disorders	Tretinoin and Arsenic Trioxide	4	17
other	Febrile neutropenia	Blood and lymphatic system disorders	Tretinoin and Arsenic Trioxide	4	17
other	Mucositis oral	Gastrointestinal disorders	Tretinoin and Arsenic Trioxide	4	17
other	Diarrhea	Gastrointestinal disorders	Tretinoin and Arsenic Trioxide	3	17
other	Eye disorders - Other, specify	Eye disorders	Tretinoin and Arsenic Trioxide	3	17
other	Headache	Nervous system disorders	Tretinoin and Arsenic Trioxide	3	17
other	Hyperglycemia	Metabolism and nutrition disorders	Tretinoin and Arsenic Trioxide	3	17
other	Alkaline phosphatase increased	Investigations	Tretinoin and Arsenic Trioxide	2	17
other	Anemia	Blood and lymphatic system disorders	Tretinoin and Arsenic Trioxide	2	17

1 to 10 of 91Source ClinicalTrials.gov

See all 91 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tretinoin and Arsenic Trioxide	2	17
Total, other adverse events	Tretinoin and Arsenic Trioxide	17	17
Total, serious adverse events	Tretinoin and Arsenic Trioxide	7	17

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT01404949

GET https://conductscience.org/api/trials/v1/NCT01404949/events?page=2

API reference For AI assistants