Trial · NCT01700673

Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS

NCT01700673, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2021-09-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS. Trials, record NCT01700673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01700673

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Trial

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

Title: Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS
NCT number: NCT01700673
Status: Completed
Phases: Phase 2
Enrollment: 25 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome
Interventions: Azacitidine, Sargramostim
First posted: 2012-10-04
Last updated: 2022-10-18
Results first posted: 2021-09-02

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Two-year Relapse Free Survival of Patients	2 year	To evaluate the two-year relapse-free survival (RFS) of patients with poor-risk Acute Myeloid Leukemia (AML) or Myelodysplasia (MDS), who receive maintenance treatment with 5-Azacytidine (5AC) in combination with sargramostim (GM-CSF) during remission, following definitive therapy with either a stem cell transplant (SCT) or cytarabine-based consolidation chemotherapy.
Secondary	Hematologic Toxicity as Determined by Anemia	1 year	Percentage of patients with anemia, the most commonly reported hematologic toxicity, after receiving the combination of Azacitidine and sargramostim
Secondary	One-year RFS	1 year	We will report the number of participants with one year RFS
Secondary	Overall Survival	2 years	Percentage of participants with overall survival at 2 years.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Two-year Relapse Free Survival of Patients	2 year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hematologic Toxicity as Determined by Anemia	1 year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	One-year RFS	1 year	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	2 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Units
Two-year Relapse Free Survival of Patients	Non-myeloablative BMT	8	Participants
Two-year Relapse Free Survival of Patients	Myeloablative BMT	1	Participants
Two-year Relapse Free Survival of Patients	Standard Consolidation	1	Participants
Hematologic Toxicity as Determined by Anemia	Non-myeloablative BMT	8	Participants
Hematologic Toxicity as Determined by Anemia	Myeloablative BMT	1	Participants
Hematologic Toxicity as Determined by Anemia	Standard Consolidation	0	Participants
One-year RFS	Non-myeloablative BMT	12	Participants
One-year RFS	Myeloablative BMT	1	Participants
One-year RFS	Standard Consolidation	1	Participants
Overall Survival	Non-myeloablative	6	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Myeloablative BMT	1
Overall Study	STARTED	Non-myeloablative BMT	23
Overall Study	STARTED	Standard Consolidation	1
Overall Study	COMPLETED	Myeloablative BMT	1
Overall Study	COMPLETED	Non-myeloablative BMT	17
Overall Study	COMPLETED	Standard Consolidation	1
Overall Study	NOT COMPLETED	Myeloablative BMT	0
Overall Study	NOT COMPLETED	Non-myeloablative BMT	6
Overall Study	NOT COMPLETED	Standard Consolidation	0

Source ClinicalTrials.gov

Adverse events105

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	nausea	Gastrointestinal disorders	Non-myeloablative BMT	8	17	13
other	nausea	Gastrointestinal disorders	Myeloablative BMT	1	1
other	nausea	Gastrointestinal disorders	Standard Consolidation	1	1	2
other	ALT increase	Blood and lymphatic system disorders	Non-myeloablative BMT	3	17	12
other	ALT increase	Blood and lymphatic system disorders	Myeloablative BMT	0	1
other	ALT increase	Blood and lymphatic system disorders	Standard Consolidation	1	1
other	anemia	Blood and lymphatic system disorders	Non-myeloablative BMT	8	17	21
other	anemia	Blood and lymphatic system disorders	Myeloablative BMT	1	1
other	anemia	Blood and lymphatic system disorders	Standard Consolidation	0	1
other	anorexia	Gastrointestinal disorders	Non-myeloablative BMT	3	17	6

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Non-myeloablative BMT	8	17
Total, all-cause mortality	Myeloablative BMT	0	1
Total, all-cause mortality	Standard Consolidation	0	1
Total, other adverse events	Non-myeloablative BMT	17	17
Total, other adverse events	Myeloablative BMT	1	1
Total, other adverse events	Standard Consolidation	1	1
Total, serious adverse events	Non-myeloablative BMT	4	17
Total, serious adverse events	Myeloablative BMT	0	1
Total, serious adverse events	Standard Consolidation	0	1

Source ClinicalTrials.gov

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
P01CA015396	Bone Marrow Transplantation in Human Disease	JONES, RICHARD J	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2016

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/NCT01700673

GET https://conductscience.org/api/trials/v1/NCT01700673/events?page=2

API reference For AI assistants