Trial · NCT02907359
Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
NCT02907359, Phase 3, Completed, Astex Pharmaceuticals, Inc.; results first posted 2023-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs. Trials, record NCT02907359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02907359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
- NCT number
- NCT02907359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 417 participants, actual
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- Interventions
- Guadecitabine, Treatment Choice
- First posted
- 2016-09-20
- Last updated
- 2024-08-27
- Other registries' IDs
- eudract:2015-005257-12
- Results first posted
- 2023-05-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization up to death (up to approximately 38.6 months) | OS was defined as the number of days from the day the participant was randomized to the date of death due to any cause. Survival time was censored on the last date the participant is known alive with no event of death. OS time will be estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Up to approximately 46.6 months | Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or cycle 1 day 1 { C1D1} visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining haemoglobin (Hgb) ≥8 gram per deciliter (g/dL) and platelets ≥20×10\^9/liter (L) divided by the total number of participants included in the efficacy analysis. RBC or Platelet transfusion independence rate was defined similarly as above. Percentage of participants are rounded off to the single decimal point. |
| Secondary | Percentage of Participants With Marrow Complete Response (mCR) Along With Transfusion Independence Rate | Up to approximately 46.6 months | mCR was defined as per 2006 Myelodysplastic Syndromes International Council for Harmonisation (MDS IWG) criteria as reduction of bone marrow (BM) blasts to ≤5% and decrease by 50% or more with or without normalization of peripheral counts. Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or C1D1 visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining Hgb ≥8 g/dL and platelets ≥20×10\^9/L divided by the total number of participants included in the efficacy analysis. The percentage of participants who achieved mCR and transfusion independence simultaneously in the same period were calculated for each group. Percentage of participants are rounded off to the single decimal point. |
| Secondary | Survival Rate at 1 Year After Randomization | From randomization up to 12 months | One year survival rate was defined as the percentage of participants that survived at the end of the first year from randomization. Participants who did not have death in record were censored on the last date known to be alive. Percentage of participants are rounded off to the nearest whole number. |
| Secondary | Leukemia-free Survival | From randomization up to 46.6 months | Leukemia-free survival was defined as the number of days from randomization to the earliest date when participants have bone marrow (BM) or peripheral blood (PB) blasts ≥20%, conversion to acute myeloid leukemia (AML) or death of any cause. Participants with no events in leukemia-free survival were censored on the last date of BM or PB blasts assessment, whichever is later. Survival time will be estimated using the Kaplan-Meier method. |
| Secondary | Number of Days Alive and Out of the Hospital (NDAOH) | Up to 6 months | 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 NDAOH within first 6 month period was calculated as: NDAOH 6M=180 -total duration of all hospital stays within 180 days from the first treatment -number of death days before Day 180. For participants who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the participant would have died the day after the last contact day. |
| Secondary | Disease Response (DR) Rate | Up to approximately 46.6 months | DR: Complete Response(CR), Partial Response(PR),Marrow Complete Response(mCR), and Hematological Improvement(HI) including HI with Erythroid (HI-E), HI with Neutrophil (HI-N), or HI with Platelet (HI-P) based on IWG 2006 criteria. CR: BM:≤5% myeloblasts, Peripheral blood: Hgb≥11g/dL, Platelets(PLTs)≥100x10\^9/L, Neutrophils≥1.0x10\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except BM blasts decreased ≥50% over pretreatment but still\>5%, Cellularity, morphology not relevant. HI responses:1) HI-E: Hgb increase ≥1.5g/dL, Relevant reduction of RBC units transfusions by absolute ≥4 RBC transfusions/8 week(wk) compared with pretreatment transfusion number previous 8wk. Only RBC transfusions given for Hgb≤9.0g/dL. 2) HI-P: Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from\<20x10\^9/L to\>20x10\^9/L and by≥100%. 3) HI-N: ≥100% increase, absolute increase\>0.5x10\^9/L. |
| Secondary | Duration of Complete Response (CR) | Up to approximately 46.6 months | Duration of complete response (in number of days) was calculated from the first time a CR was observed to the date of the earliest of the following three events: 1) relapse/disease progression, 2) start of alternative therapy (except Hematopoietic Cell Transplant \[HCT\]) or 3) death. In the absence of any event, the duration of CR was censored at the last available time point (BM assessment, PB assessment, or safety/long-term follow-up visit) at which an event was not observed. Duration of complete response was analysed using a Kaplan-Meier method for participants who achieved a CR during the study. CR: BM: ≤5% myeloblasts (all cell lines normal maturation), Peripheral blood: Hgb ≥11g/dL, PLTs ≥100x10\^9/L, Neutrophils ≥1.0x10\^9/L, Blasts 0%. |
| Secondary | Time to First Response, Complete Response (CR) and Best Response | From study Day 1 to the earliest date that a response was first documented (up to approximately 46.6 months) | Time to first response was the time(days) from randomization to first date when any response was achieved. Time to CR was the time(days) from randomization to first date when CR was achieved. Time to best response was the time(days) from randomization to first date when participant's best response (CR,PR,mCR or HI) was achieved. CR:BM:≤5% myeloblasts, Peripheral blood:Hgb≥11g/dL,PLTs≥100x10\^9/L,Neutrophils≥1.0x10\^9/L,Blasts 0%. PR: All CR criteria except BM blasts decreased≥50% over pretreatment but still \>5%,Cellularity,morphology not relevant. mCR: Reduction of BM blasts to≤5%; decrease ≥50% with/without normalization of peripheral counts. HI responses:1)HI-E:Hgb increase≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute≥4 RBC transfusions/8wk compared with pretreatment transfusion number previous 8wk. 2)HI-P:Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from≤20 to\>20x10\^9/L and by≥100% 3)HI-N:≥100% granulocyte increase, absolute increase\>0.5x10\^9/L. |
| Secondary | Number of Red Blood Cell (RBC) and Platelet Transfusions | Up to 6 months | The total number of 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. The mean total number of RBC or platelet units transfused per participant is presented. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization up to death (up to approximately 38.6 months) | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Up to approximately 46.6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Marrow Complete Response (mCR) Along With Transfusion Independence Rate | Up to approximately 46.6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Survival Rate at 1 Year After Randomization | From randomization up to 12 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Leukemia-free Survival | From randomization up to 46.6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | days | MEDIAN |
| SECONDARY | Number of Days Alive and Out of the Hospital (NDAOH) | Up to 6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | days | MEDIAN |
| SECONDARY | Disease Response (DR) Rate | Up to approximately 46.6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Participants who had multiple responses of HI (HI-E, HI-N and HI-P) were counted only once while calculating the total HI value in both treatment groups. Percentage of participants are rounded off to the nearest single decimal point. | percentage of participants | NUMBER |
| SECONDARY | Duration of Complete Response (CR) | Up to approximately 46.6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with CR (responders) only. | days | MEDIAN |
| SECONDARY | Time to First Response, Complete Response (CR) and Best Response | From study Day 1 to the earliest date that a response was first documented (up to approximately 46.6 months) | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with response. | days | MEDIAN |
| SECONDARY | Number of Red Blood Cell (RBC) and Platelet Transfusions | Up to 6 months | The Efficacy Analysis Set included all participants randomly assigned to the study treatment. | units of transfused RBC or platelet | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Guadecitabine | 277.0 | 95% Confidence Interval 243.0 to 313.0 | days | |
| Overall Survival (OS) | Treatment Choice | 252.0 | 95% Confidence Interval 200.0 to 325.0 | days | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Guadecitabine | Transfusion Independence Rate (8 weeks) | 15.9 | percentage of participants | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Treatment Choice | Transfusion Independence Rate (8 weeks) | 15.7 | percentage of participants | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Guadecitabine | Platelet Transfusion Independence Rate | 32.1 | percentage of participants | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Treatment Choice | Platelet Transfusion Independence Rate | 37.9 | percentage of participants | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Guadecitabine | RBC Transfusion Independence Rate | 22.4 | percentage of participants | |
| Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks | Treatment Choice | RBC Transfusion Independence Rate | 22.0 | percentage of participants | |
| Percentage of Participants With Marrow Complete Response (mCR) Along With Transfusion Independence Rate | Guadecitabine | 5.8 | percentage of participants | ||
| Percentage of Participants With Marrow Complete Response (mCR) Along With Transfusion Independence Rate | Treatment Choice | 2.9 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Guadecitabine | 277 | |
| Overall Study | STARTED | Treatment Choice | 140 | |
| Overall Study | Safety Analysis Set | Guadecitabine | 270 | |
| Overall Study | Safety Analysis Set | Treatment Choice | 122 | |
| Overall Study | COMPLETED | Guadecitabine | 36 | |
| Overall Study | COMPLETED | Treatment Choice | 12 | |
| Overall Study | NOT COMPLETED | Guadecitabine | 241 | |
| Overall Study | NOT COMPLETED | Treatment Choice | 128 |
Source ClinicalTrials.gov
Adverse events504
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 | Anaemia | Blood and lymphatic system disorders | Guadecitabine | 63 | 270 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Choice | 22 | 122 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Guadecitabine | 38 | 270 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Treatment Choice | 6 | 122 | |
| other | Leukopenia | Blood and lymphatic system disorders | Guadecitabine | 32 | 270 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Choice | 12 | 122 | |
| other | Neutropenia | Blood and lymphatic system disorders | Guadecitabine | 92 | 270 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment Choice | 19 | 122 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Guadecitabine | 84 | 270 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Choice | 25 | 122 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Guadecitabine | 237 | 277 |
| Total, all-cause mortality | Treatment Choice | 122 | 140 |
| Total, other adverse events | Guadecitabine | 266 | 270 |
| Total, other adverse events | Treatment Choice | 107 | 122 |
| Total, serious adverse events | Guadecitabine | 216 | 270 |
| Total, serious adverse events | Treatment Choice | 65 | 122 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Guadecitabine vs Treatment Choice: deaths from any cause | Trial comparisons |
| 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.
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Read this trial from software.
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