Trial · NCT04802161

Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes

NCT04802161, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-12-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes. Trials, record NCT04802161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04802161

On this page

Trial

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

Title: Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes
NCT number: NCT04802161
Status: Active not recruiting
Phases: Phase 2
Enrollment: 49 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia With Multilineage Dysplasia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
Interventions: Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Liposome-encapsulated Daunorubicin-Cytarabine, Pomalidomide
First posted: 2021-03-17
Last updated: 2026-06-30
Results first posted: 2025-12-19

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)	Up to 2 years
Secondary	CR With Full Hematologic Recovery (Absolute Neutrophil Count > 1 x 10^9/L and Platelets > 100 x 10^9/L)	Up to 5 years	Will be assessed and compared with both arms A and B.
Secondary	Incidence of Adverse Events	Up to 30 days after last dose, up to 2 years	Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 and compared descriptively between Arms A and B. Serious adverse events are denoted by "\[SAE\]".
Secondary	Complete Response (CR) Without Minimal Residual Disease (MRD)	Up to 5 years	Will assess CR without MRD by flow cytometry via Hematologics, Inc. compare descriptively between Arms A and B.
Secondary	Event-free Survival	From day 1 of liposome-encapsulated daunorubicin-cytarabine until no response is achieved, relapse or death, will be assessed for up to 5 years	Will be compared between Arms A and B.
Secondary	Disease-free Survival (DFS)	From CR/CRi until relapse or death, assessed at 2 years	Will be compared between Arms A and B.
Secondary	Disease-free Survival	From CR/CRi until relapse or death, assessed up to 5 years	Will be compared between Arms A and B.
Secondary	Overall Survival (OS)	From randomization until death or last follow-up, assessed up to 5 years	Will be compared between Arms A and B.
Secondary	Rate of Allogeneic Stem Cell Transplantation	Up to 5 years	Will be compared between Arms A and B.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)	Up to 2 years	This outcome measure was not reported on for the safety run-in phase	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	CR With Full Hematologic Recovery (Absolute Neutrophil Count > 1 x 10^9/L and Platelets > 100 x 10^9/L)	Up to 5 years
SECONDARY	Incidence of Adverse Events	Up to 30 days after last dose, up to 2 years		participants	NUMBER
SECONDARY	Complete Response (CR) Without Minimal Residual Disease (MRD)	Up to 5 years
SECONDARY	Event-free Survival	From day 1 of liposome-encapsulated daunorubicin-cytarabine until no response is achieved, relapse or death, will be assessed for up to 5 years
SECONDARY	Disease-free Survival (DFS)	From CR/CRi until relapse or death, assessed at 2 years	This outcome measure was not reported on for the safety run-in phase	months	MEDIAN
SECONDARY	Disease-free Survival	From CR/CRi until relapse or death, assessed up to 5 years
SECONDARY	Overall Survival (OS)	From randomization until death or last follow-up, assessed up to 5 years
SECONDARY	Rate of Allogeneic Stem Cell Transplantation	Up to 5 years

Source ClinicalTrials.gov

Results by group1,140

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

Outcome	Group	Category	Value	Units
Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)		9	Participants
Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)	Arm B (Daunorubicin and Cytarabine Liposome)		13	Participants
Incidence of Adverse Events	Safety Run In DL1 (14 Days Pomalidomide)	Alanine Aminotransferase Increased	4	participants
Incidence of Adverse Events	Safety Run In DL-1 (10 Days Pomalidomide)	Alanine Aminotransferase Increased	2	participants
Incidence of Adverse Events	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	Alanine Aminotransferase Increased	8	participants
Incidence of Adverse Events	Arm B (Daunorubicin and Cytarabine Liposome)	Alanine Aminotransferase Increased	8	participants
Incidence of Adverse Events	Safety Run In DL1 (14 Days Pomalidomide)	Aspartate Aminotransferase Increased	6	participants
Incidence of Adverse Events	Safety Run In DL-1 (10 Days Pomalidomide)	Aspartate Aminotransferase Increased	2	participants
Incidence of Adverse Events	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	Aspartate Aminotransferase Increased	8	participants
Incidence of Adverse Events	Arm B (Daunorubicin and Cytarabine Liposome)	Aspartate Aminotransferase Increased	8	participants

1 to 10 of 1,140Source ClinicalTrials.gov

See all 1,140 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Safety Run In DL1 (14 Days Pomalidomide)	7
Overall Study	STARTED	Safety Run In DL-1 (10 Days Pomalidomide)	3
Overall Study	STARTED	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	20
Overall Study	STARTED	Arm B (Daunorubicin and Cytarabine Liposome)	19
Overall Study	COMPLETED	Safety Run In DL1 (14 Days Pomalidomide)	6
Overall Study	COMPLETED	Safety Run In DL-1 (10 Days Pomalidomide)	3
Overall Study	COMPLETED	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	16
Overall Study	COMPLETED	Arm B (Daunorubicin and Cytarabine Liposome)	18
Overall Study	NOT COMPLETED	Safety Run In DL1 (14 Days Pomalidomide)	1
Overall Study	NOT COMPLETED	Safety Run In DL-1 (10 Days Pomalidomide)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,164

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	Alanine Aminotransferase Increased	Investigations	Safety Run In DL1 (14 Days Pomalidomide)	4	7	17
other	Alanine Aminotransferase Increased	Investigations	Safety Run In DL-1 (10 Days Pomalidomide)	2	3	10
other	Alanine Aminotransferase Increased	Investigations	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	8	20	24
other	Alanine Aminotransferase Increased	Investigations	Arm B (Daunorubicin and Cytarabine Liposome)	8	19	27
other	Aspartate Aminotransferase Increased	Investigations	Safety Run In DL1 (14 Days Pomalidomide)	6	7	25
other	Aspartate Aminotransferase Increased	Investigations	Safety Run In DL-1 (10 Days Pomalidomide)	2	3	16
other	Aspartate Aminotransferase Increased	Investigations	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	8	20	34
other	Aspartate Aminotransferase Increased	Investigations	Arm B (Daunorubicin and Cytarabine Liposome)	8	19	36
other	Abdominal distension	Gastrointestinal disorders	Safety Run In DL1 (14 Days Pomalidomide)	0	7	0
other	Abdominal distension	Gastrointestinal disorders	Safety Run In DL-1 (10 Days Pomalidomide)	0	3	0

1 to 10 of 1,164Source ClinicalTrials.gov

See all 1,164 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Safety Run In DL1 (14 Days Pomalidomide)	3	7
Total, all-cause mortality	Safety Run In DL-1 (10 Days Pomalidomide)	2	3
Total, all-cause mortality	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	11	20
Total, all-cause mortality	Arm B (Daunorubicin and Cytarabine Liposome)	7	19
Total, other adverse events	Safety Run In DL1 (14 Days Pomalidomide)	7	7
Total, other adverse events	Safety Run In DL-1 (10 Days Pomalidomide)	3	3
Total, other adverse events	Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)	20	20
Total, other adverse events	Arm B (Daunorubicin and Cytarabine Liposome)	18	19
Total, serious adverse events	Safety Run In DL1 (14 Days Pomalidomide)	7	7
Total, serious adverse events	Safety Run In DL-1 (10 Days Pomalidomide)	3	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1CA186712	The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network	CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH	OHIO STATE UNIVERSITY	NATIONAL CANCER INSTITUTE	2014 to 2025

Source NIH RePORTER

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/NCT04802161

GET https://conductscience.org/api/trials/v1/NCT04802161/results?page=2

API reference For AI assistants