NCT01599325 is a Phase 2 clinical trial of Azacitidine in Myelodysplastic Syndrome (MDS), sponsored by Celgene.

Who is sponsoring NCT01599325?

NCT01599325 is sponsored by Celgene.

What drugs are being tested in NCT01599325?

Interventions in NCT01599325: Azacitidine.

What condition does NCT01599325 study?

NCT01599325 studies Myelodysplastic Syndrome (MDS).

Is NCT01599325 still recruiting?

NCT01599325 is currently completed. Last updated 19 March 2019.

Are results published for NCT01599325?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-19 · How we verify

NCT01599325

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome

Completed Phase 2 Results posted Last updated 19 March 2019

What this trial tests

Phase 2 trial testing Azacitidine in Myelodysplastic Syndrome (MDS) in 72 participants. Completed in 13 March 2018.

Timeline

24 July 2012

Primary endpoint
29 January 2015

13 March 2018

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	24 July 2012
Primary completion	29 January 2015
Estimated completion	13 March 2018
Sites	11 locations across China

Drugs / interventions tested

Azacitidine (azacitidine) — full drug profile →

Conditions studied

Myelodysplastic Syndrome (MDS) — all drugs for Myelodysplastic Syndrome (MDS) →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Myelodysplastic Syndrome (MDS). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Hematologic Response Based on the International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Programmatically Assessed by the Sponsor Using Clinically Relevant Data. Primary · Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days

Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows \<5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (\>110 g/L), neutrophils (≥1.5x10\^9/L), platelets (≥100x10\^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression fo

Overall CR+PR

Group	Value	95% CI
Azacitidine	1.4	0.0 – 7.5

Overall CR+PR+SD

Group	Value	95% CI
Azacitidine	95.8	88.3 – 99.1

Complete Remission (CR)

Group	Value	95% CI
Azacitidine	1.4	0.0 – 7.5

Partial Remission (PR)

Group	Value	95% CI
Azacitidine	0	0.0 – 5.0

Percentage of Participants With a Hematologic Response Using IWG Criteria for MDS and Assessed by the Investigator Primary · Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days

Overall CR+PR

Group	Value	95% CI
Azacitidine	12.5	5.9 – 22.4

Overall CR+PR+SD

Group	Value	95% CI
Azacitidine	70.8	58.9 – 81.0

Group	Value	95% CI
Azacitidine	6.9	2.3 – 15.5

Group	Value	95% CI
Azacitidine	5.6	1.5 – 13.6

Percentage of Participants Achieving a Hematologic Improvement (HI) Based on 2000 IWG Response Criteria for MDS and Programmatically Assessed by the Sponsor Using Clinically Relevant Data. Primary · Up to 29 January 2015; 894 days

Hematologic improvements (HI) have 4 categories: 1. Erythroid response (HI-E): Major \>20g/L increase or transfusion independent. Minor: 10-20g/L increase or ≥50% decrease in transfusion requirements. 2. Platelet response (HI-P): Major absolute increase of ≥30x10\^9/L or platelet transfusion independence. Minor: ≥50% increase. 3. Neutrophil response (HI-N): Major 100% increase or an absolute increase of \>0.5x10\^9/L. Minor: ≥100% increase and absolute increase of \<0.5x10\^9/L 4. Progression or relapse after HI Hematological improvement (HI) was defined as any type (major or minor) of improve

Any improvement

Group	Value	95% CI
Azacitidine	52.8	40.7 – 64.7

Hematologic Improvement-E (major)

Group	Value	95% CI
Azacitidine	35.8	24.5 – 48.5

Hematologic Improvement-E (minor)

Group	Value	95% CI
Azacitidine	9.0	3.4 – 18.5

Hematologic Improvement-P (major)

Group	Value	95% CI
Azacitidine	37.9	25.5 – 51.6

Hematologic Improvement-P (minor)

Group	Value	95% CI
Azacitidine	0.0	0.0 – 6.2

Hematologic Improvement-N (major)

Group	Value	95% CI
Azacitidine	21.8	11.8 – 35.0

Hematologic Improvement-N (minor)

Group	Value	95% CI
Azacitidine	0.0	0.0 – 6.5

The Number of Units of Platelet Transfusions by Cycle Secondary · Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days

The number of units of platelet transfusions received 56 days prior to treatment, considered the baseline period, (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: \[(# of transfusions in the measurement period / length of the measurement period (days)) x 28\], where the measurement peri

Baseline N = 72

Group	Value	95% CI
Azacitidine	1.9	± 4.91

Overall Post-Baseline Average N = 72

Group	Value	95% CI
Azacitidine	4.7	± 17.79

Overall Change from Baseline N = 72

Group	Value	95% CI
Azacitidine	2.8	± 17.89

Cycle 1 N = 72

Group	Value	95% CI
Azacitidine	5.2	± 18.83

Cycle 2

Group	Value	95% CI
Azacitidine	2.4	± 5.86

Cycle 3

Group	Value	95% CI
Azacitidine	3.3	± 11.44

Cycle 4

Group	Value	95% CI
Azacitidine	2.7	± 6.13

Cycle 5

Group	Value	95% CI
Azacitidine	2.5	± 7.69

The Number of Platelet Transfusions by Cycle Secondary · Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days

The number of platelet transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: \[(# of transfusions in the measurement period / length of the measurement period (days)) x 28\], where the measurement period was eit

Baseline N = 72

Group	Value	95% CI
Azacitidine	0.8	± 2.36

Overall Post-Baseline Average N = 72

Group	Value	95% CI
Azacitidine	1.6	± 2.83

Overall Change from Baseline N = 72

Group	Value	95% CI
Azacitidine	0.8	± 3.29

Cycle 1 N = 72

Group	Value	95% CI
Azacitidine	1.8	± 2.89

Cycle 2

Group	Value	95% CI
Azacitidine	1.3	± 2.59

Cycle 3

Group	Value	95% CI
Azacitidine	1.2	± 2.28

Cycle 4

Group	Value	95% CI
Azacitidine	1.3	± 2.18

Cycle 5

Group	Value	95% CI
Azacitidine	0.9	± 1.58

The Number of Units of Red Blood Cell (RBC) Transfusions by Cycle Secondary · Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days

The number of units of RBC received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for RBC. The formula for standardizing per 28 days was: \[(# of transfusions in the measurement period / length of the measurement period (days)) x 28\], where the measurement period was either baseline or

Baseline N = 72

Group	Value	95% CI
Azacitidine	2.3	± 3.55

Overall Post-Baseline Average N = 72

Group	Value	95% CI
Azacitidine	3.5	± 3.88

Overall Change from Baseline N = 72

Group	Value	95% CI
Azacitidine	1.2	± 4.34

Cycle 1 N = 72

Group	Value	95% CI
Azacitidine	3.6	± 3.41

Cycle 2

Group	Value	95% CI
Azacitidine	3.6	± 4.88

Cycle 3

Group	Value	95% CI
Azacitidine	3.0	± 3.68

Cycle 4

Group	Value	95% CI
Azacitidine	2.7	± 3.73

Cycle 5

Group	Value	95% CI
Azacitidine	2.5	± 3.94

The Number of RBC Transfusions by Cycle Secondary · Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days

The number of RBC transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: \[(# of transfusions in the measurement period / length of the measurement period (days)) x 28\], where the measurement period was either b

Baseline N = 72

Group	Value	95% CI
Azacitidine	1.1	± 1.79

Overall Post-Baseline Average N = 72

Group	Value	95% CI
Azacitidine	1.6	± 1.97

Overall Change from Baseline N = 72

Group	Value	95% CI
Azacitidine	0.5	± 2.12

Cycle 1 N = 72

Group	Value	95% CI
Azacitidine	1.7	± 1.64

Cycle 2

Group	Value	95% CI
Azacitidine	1.7	± 2.56

Cycle 3

Group	Value	95% CI
Azacitidine	1.4	± 1.81

Cycle 4

Group	Value	95% CI
Azacitidine	1.2	± 1.73

Cycle 5

Group	Value	95% CI
Azacitidine	1.1	± 1.81

The Number of Infections (Post-baseline Average) Requiring Intravenous (IV) Antibiotics, Anti-fungals, or Antivirals by Cycle Secondary · Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days

The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle.

Baseline N = 72

Group	Value	95% CI
Azacitidine	0.0	± 0.20

Overall Post Baseline Average N = 72

Group	Value	95% CI
Azacitidine	0.6	± 1.43

Overall Change from Baseline N =72

Group	Value	95% CI
Azacitidine	0.5	± 1.45

Cycle 1 N = 72

Group	Value	95% CI
Azacitidine	0.6	± 1.32

Cycle 2

Group	Value	95% CI
Azacitidine	0.5	± 1.67

Cycle 3

Group	Value	95% CI
Azacitidine	0.4	± 0.86

Cycle 4

Group	Value	95% CI
Azacitidine	0.5	± 1.03

Cycle 5

Group	Value	95% CI
Azacitidine	0.4	± 0.72

Kaplan Meier Estimates for Overall Survival (OS) Secondary · Until the end of the survival follow-up period; Up to data cut-off of 29 January 2015; 894 days

Overall survival is defined as time to death from any cause, is calculated using date of first dose and date of death, or date of last follow-up for censored participants. Those, who die regardless of the cause of death, will be considered to have an event.

Median OS

Group	Value	95% CI
Azacitidine	22.0	15.1 – NA

25th percentile OS

Group	Value	95% CI
Azacitidine	8.5	6.1 – 13.8

75th Percentile OS

Group	Value	95% CI
Azacitidine	NA	24.2 – NA

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Parent Phase Secondary · Up to 29 January 2015; from the first dose of study drug to 28 days after the date of the last dose of study drug (maximum time on study was 244 days)

A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-poi

≥ 1 TEAE

Group	Value	95% CI
Azacitidine	72

≥ 1 Grade 3 or 4 TEAE

Group	Value	95% CI
Azacitidine	70

≥ 1 TEAE related to study drug

Group	Value	95% CI
Azacitidine	68

≥ 1 Grade 3 or 4 TEAE related to study drug

Group	Value	95% CI
Azacitidine	59

≥ 1 serious TEAE

Group	Value	95% CI
Azacitidine	38

≥ 1 Grade 3 or 4 serious TEAE

Group	Value	95% CI
Azacitidine	33

≥ 1 serious TEAE related to study drug

Group	Value	95% CI
Azacitidine	28

≥ 1 TEAE leading to discontinuation of study drug

Group	Value	95% CI
Azacitidine	14

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine Secondary · PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7

Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation will be performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ will not be reported

Group	Value	95% CI
Azacitidine	1172.6	± 18.0

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine Secondary · PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.

Group	Value	95% CI
Azacitidine	1161.9	± 17.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Azacitidine Exposure across all cycles: median duration of azacitidine treatment was 786 days (range 428 to 1507).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Azacitidine - Parent Phase

Serious: 38/72 (53%)

Deaths: 13/72

Azacitdine - Extension Phase

Serious: 5/15 (33%)

Deaths: 0/15

Serious adverse events (52 terms)

Reaction	System	Azacitidine - Parent Phase	Azacitdine - Extension Phase
Pneumonia	Infections and infestations	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Agranulocytosis	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Mouth haemorrhage	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Bone marrow failure	Blood and lymphatic system disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Cellulitis	Infections and infestations	—	—
Lung infection	Infections and infestations	—	—
Abdominal infection	Infections and infestations	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Abscess limb	Infections and infestations	—	—
Anal abscess	Infections and infestations	—	—
Anal infection	Infections and infestations	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—
Atrioventricular block	Cardiac disorders	—	—
Bronchopneumonia	Infections and infestations	—	—
Cerebral haemorrhage	Nervous system disorders	—	—
Cerebral ischaemia	Nervous system disorders	—	—
Drug hypersensitivity	Immune system disorders	—	—
Fungal sepsis	Infections and infestations	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—

Other adverse events (79 terms — click to expand)

Reaction	System	Azacitidine - Parent Phase	Azacitdine - Extension Phase
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Gingivitis	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Insomnia	Psychiatric disorders	—	—
Weight decreased	Investigations	—	—
Alanine aminotransferase increased	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Oedema peripheral	General disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Gingival bleeding	Gastrointestinal disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Lung infection	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Asthenia	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Mouth ulceration	Gastrointestinal disorders	—	—
Transfusion reaction	Injury, poisoning and procedural complications	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Gingival infection	Infections and infestations	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Purpura	Skin and subcutaneous tissue disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Cellulitis	Infections and infestations	—	—
Conjunctival haemorrhage	Eye disorders	—	—
Fatigue	General disorders	—	—

Most-reported serious reactions: Pneumonia, Febrile neutropenia, Agranulocytosis, Thrombocytopenia, Upper respiratory tract infection, Mouth haemorrhage, Pyrexia, Anaemia.

Data from ClinicalTrials.gov NCT01599325 adverse events section.

Sponsor's own description

The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
Epimutational profile of hematologic malignancies as attractive target for new epigenetic therapies.
Fratta E, Montico B, Rizzo A, Colizzi F, et al · · 2016 · cited 17× · PMID 27329599 · DOI 10.18632/oncotarget.10033
Dynamics of PD-1 expression are associated with treatment efficacy and prognosis in patients with intermediate/high-risk myelodysplastic syndromes under hypomethylating treatment.
Geng S, Xu R, Huang X, Li M, et al · · 2022 · cited 7× · PMID 36003379 · DOI 10.3389/fimmu.2022.950134
Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?
Brunner AM, Fell G, Steensma DP. · · 2022 · cited 3× · PMID 35143613 · DOI 10.1182/bloodadvances.2021006357

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01599325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 19 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01599325.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01599325

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (52 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Azacitidine

Other recruiting trials for Myelodysplastic Syndrome (MDS)

Other Celgene trials

Verify against primary sources