Trial · NCT02348489
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
NCT02348489, Phase 3, Completed, Astex Pharmaceuticals, Inc.; results first posted 2021-01-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction. Trials, record NCT02348489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348489
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
- NCT number
- NCT02348489
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 815 participants, actual
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- SGI-110 (guadecitabine), Treatment Choice
- First posted
- 2015-01-28
- Last updated
- 2024-08-27
- Results first posted
- 2021-01-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Complete Response (CR) | Up to 38 months (median follow-up of 25.5 months) | Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist. |
| Primary | Overall Survival | At 676 death events (up to 38 months) | Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause. |
| Secondary | Number of Participants With Composite CR (CRc) | Up to 38 months (median follow-up of 25.5 months) | CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi). |
| Secondary | Number of Days Alive and Out of the Hospital | Month 6 | The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day. |
| Secondary | Progression-free Survival (PFS) | Up to 38 months (median follow-up of 25.5 months) | Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause. |
| Secondary | Number of Red Blood Cell or Platelet Transfusions | Month 6 | The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit. |
| Secondary | Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L | Baseline to Month 6 | EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state. |
| Secondary | Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS | Baseline to Month 6 | EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized. |
| Secondary | Duration of CR | Up to 38 months (median follow-up of 25.5 months) | Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM. |
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 | Number of Participants With a Complete Response (CR) | Up to 38 months (median follow-up of 25.5 months) | The efficacy analysis set includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival | At 676 death events (up to 38 months) | The efficacy analysis set includes all randomized participants. | days | MEDIAN |
| SECONDARY | Number of Participants With Composite CR (CRc) | Up to 38 months (median follow-up of 25.5 months) | The efficacy analysis set includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Days Alive and Out of the Hospital | Month 6 | The efficacy analysis set includes all randomized participants. | days | MEAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 38 months (median follow-up of 25.5 months) | The efficacy analysis set includes all randomized participants. | days | MEDIAN |
| SECONDARY | Number of Red Blood Cell or Platelet Transfusions | Month 6 | The efficacy analysis set includes all randomized participants. | transfusion units | MEAN |
| SECONDARY | Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L | Baseline to Month 6 | The efficacy analysis set includes all randomized participants. | score on a scale | MEAN |
| SECONDARY | Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS | Baseline to Month 6 | The efficacy analysis set includes all randomized participants. | score on a scale | MEAN |
| SECONDARY | Duration of CR | Up to 38 months (median follow-up of 25.5 months) | The efficacy analysis set includes all randomized participants. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Complete Response (CR) | SGI-110 (Guadecitabine) | 79 | Participants | ||
| Number of Participants With a Complete Response (CR) | Treatment Choice | 71 | Participants | ||
| Overall Survival | SGI-110 (Guadecitabine) | 213 | 95% Confidence Interval 187 to 255 | days | |
| Overall Survival | Treatment Choice | 254 | 95% Confidence Interval 223 to 282 | days | |
| Number of Participants With Composite CR (CRc) | SGI-110 (Guadecitabine) | 93 | Participants | ||
| Number of Participants With Composite CR (CRc) | Treatment Choice | 91 | Participants | ||
| Number of Days Alive and Out of the Hospital | SGI-110 (Guadecitabine) | 98.1 | Standard Deviation 63.6 | days | |
| Number of Days Alive and Out of the Hospital | Treatment Choice | 105.7 | Standard Deviation 63.58 | days | |
| Progression-free Survival (PFS) | SGI-110 (Guadecitabine) | 159 | 95% Confidence Interval 136 to 178 | days | |
| Progression-free Survival (PFS) | Treatment Choice | 166 | 95% Confidence Interval 148 to 179 | days |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SGI-110 (Guadecitabine) | 408 | |
| Overall Study | STARTED | Treatment Choice | 407 | |
| Overall Study | COMPLETED | SGI-110 (Guadecitabine) | 55 | |
| Overall Study | COMPLETED | Treatment Choice | 40 | |
| Overall Study | NOT COMPLETED | SGI-110 (Guadecitabine) | 353 | |
| Overall Study | NOT COMPLETED | Treatment Choice | 367 |
Source ClinicalTrials.gov
Adverse events872
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 | Anemia | Blood and lymphatic system disorders | SGI-110 (Guadecitabine) | 88 | 401 | 211 |
| other | Anemia | Blood and lymphatic system disorders | Treatment Choice | 78 | 392 | 201 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | SGI-110 (Guadecitabine) | 66 | 401 | 103 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment Choice | 40 | 392 | 57 |
| other | Leukopenia | Blood and lymphatic system disorders | SGI-110 (Guadecitabine) | 37 | 401 | 120 |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Choice | 33 | 392 | 124 |
| other | Neutropenia | Blood and lymphatic system disorders | SGI-110 (Guadecitabine) | 115 | 401 | 319 |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment Choice | 88 | 392 | 233 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | SGI-110 (Guadecitabine) | 116 | 401 | 380 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Choice | 101 | 392 | 313 |
1 to 10 of 872Source ClinicalTrials.gov
See all 872 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SGI-110 (Guadecitabine) | 341 | 408 |
| Total, all-cause mortality | Treatment Choice | 344 | 407 |
| Total, other adverse events | SGI-110 (Guadecitabine) | 379 | 401 |
| Total, other adverse events | Treatment Choice | 371 | 392 |
| Total, serious adverse events | SGI-110 (Guadecitabine) | 327 | 401 |
| Total, serious adverse events | Treatment Choice | 297 | 392 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37276510 | DERIVED |
Source 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 |
|---|---|
| SGI-110 (Guadecitabine) vs Treatment Choice: Number of Participants With Composite CR (CRc) | Trial comparisons |
| SGI-110 (Guadecitabine) vs Treatment Choice: Number of Participants With a Complete Response (CR) | Trial comparisons |
| SGI-110 (Guadecitabine) vs Treatment Choice: deaths from any cause | Trial comparisons |
| SGI-110 (Guadecitabine) vs Treatment Choice: 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.
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/NCT02348489
GET https://conductscience.org/api/trials/v1/NCT02348489/results?page=2