Trial · NCT03416179
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
NCT03416179, Phase 3, Completed, Pfizer; results first posted 2021-06-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia. Trials, record NCT03416179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03416179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
- NCT number
- NCT03416179
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 730 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- glasdegib, daunorubicin + cytarabine, azacitidine, Placebo, Placebo, glasdegib, cytarabine, HSCT
- First posted
- 2018-01-31
- Last updated
- 2023-04-21
- Other registries' IDs
- eudract:2017-002822-19
- Results first posted
- 2021-06-25
- Limitations and caveats
In this study, inadvertently a participant was counted twice for an non-SAE Pyrexia at PCD, at SCD update this duplicity has been rectified. Due to this reason total number of participants affected by non-SAE in non-intensive placebo arm was updated to 148.
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
| Primary | Non-intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
| Secondary | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Post-baseline up to Week 8 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure. |
| Secondary | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Post-baseline up to Week 12 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\*10\^9/Liter (L); platelet count \>=100\*10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC). |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intensive Study: Overall Survival (OS) | Baseline up to 25 months | FA set included all randomized participants. | months | MEDIAN |
| PRIMARY | Non-intensive Study: Overall Survival (OS) | Baseline up to 25 months | FA set included all randomized participants. | months | MEDIAN |
| SECONDARY | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Post-baseline up to Week 8 | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Post-baseline up to Week 12 | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 2 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 3 years | FA set included all randomized participants. | Percentage of participants | NUMBER |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group625
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intensive Study: Overall Survival (OS) | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 17.3 | 95% Confidence Interval 15.2 to 18.5 | months | |
| Intensive Study: Overall Survival (OS) | Intensive Study: Placebo + Cytarabine + Daunorubicin | 20.4 | 95% Confidence Interval 17.6 to NA | months | |
| Non-intensive Study: Overall Survival (OS) | Non-intensive Study: Glasdegib + Azacitidine | 10.3 | 95% Confidence Interval 7.7 to 12.4 | months | |
| Non-intensive Study: Overall Survival (OS) | Non-intensive Study: Placebo + Azacitidine | 10.6 | 95% Confidence Interval 8.4 to 13.3 | months | |
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 17.41 | 95% Confidence Interval 12.17 to 22.66 | Percentage of participants | |
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Intensive Study: Placebo + Cytarabine + Daunorubicin | 17.24 | 95% Confidence Interval 12.05 to 22.44 | Percentage of participants | |
| Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Non-intensive Study: Glasdegib + Azacitidine | 11.66 | 95% Confidence Interval 6.73 to 16.58 | Percentage of participants | |
| Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Non-intensive Study: Placebo + Azacitidine | 15.43 | 95% Confidence Interval 9.87 to 21.00 | Percentage of participants | |
| Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 5.0 | 95% Confidence Interval 2.4 to 9.0 | Percentage of participants | |
| Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Intensive Study: Placebo + Cytarabine + Daunorubicin | 5.4 | 95% Confidence Interval 2.7 to 9.5 | Percentage of participants |
1 to 10 of 625Source ClinicalTrials.gov
See all 625 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 201 | |
| Overall Study | STARTED | Intensive Study: Placebo + Cytarabine + Daunorubicin | 203 | |
| Overall Study | STARTED | Non-intensive Study: Glasdegib + Azacitidine | 163 | |
| Overall Study | STARTED | Non-intensive Study: Placebo + Azacitidine | 162 | |
| Overall Study | Treated | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 198 | |
| Overall Study | Treated | Intensive Study: Placebo + Cytarabine + Daunorubicin | 201 | |
| Overall Study | Treated | Non-intensive Study: Glasdegib + Azacitidine | 162 | |
| Overall Study | Treated | Non-intensive Study: Placebo + Azacitidine | 160 | |
| Overall Study | COMPLETED | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 0 | |
| Overall Study | COMPLETED | Intensive Study: Placebo + Cytarabine + Daunorubicin | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,336
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 | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 101 | 198 | |
| other | Anaemia | Blood and lymphatic system disorders | Intensive Study: Placebo + Cytarabine + Daunorubicin | 97 | 201 | |
| other | Anaemia | Blood and lymphatic system disorders | Non-intensive Study: Glasdegib + Azacitidine | 73 | 162 | |
| other | Anaemia | Blood and lymphatic system disorders | Non-intensive Study: Placebo + Azacitidine | 71 | 160 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 97 | 198 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Intensive Study: Placebo + Cytarabine + Daunorubicin | 96 | 201 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Non-intensive Study: Glasdegib + Azacitidine | 23 | 162 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Non-intensive Study: Placebo + Azacitidine | 22 | 160 | |
| other | Leukopenia | Blood and lymphatic system disorders | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 10 | 198 | |
| other | Leukopenia | Blood and lymphatic system disorders | Intensive Study: Placebo + Cytarabine + Daunorubicin | 13 | 201 |
1 to 10 of 1,336Source ClinicalTrials.gov
See all 1,336 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 90 | 201 |
| Total, all-cause mortality | Intensive Study: Placebo + Cytarabine + Daunorubicin | 88 | 203 |
| Total, all-cause mortality | Non-intensive Study: Glasdegib + Azacitidine | 117 | 163 |
| Total, all-cause mortality | Non-intensive Study: Placebo + Azacitidine | 113 | 162 |
| Total, other adverse events | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 194 | 198 |
| Total, other adverse events | Intensive Study: Placebo + Cytarabine + Daunorubicin | 195 | 201 |
| Total, other adverse events | Non-intensive Study: Glasdegib + Azacitidine | 154 | 162 |
| Total, other adverse events | Non-intensive Study: Placebo + Azacitidine | 148 | 160 |
| Total, serious adverse events | Intensive Study: Glasdegib + Cytarabine + Daunorubicin | 86 | 198 |
| Total, serious adverse events | Intensive Study: Placebo + Cytarabine + Daunorubicin | 92 | 201 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 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.
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/NCT03416179
GET https://conductscience.org/api/trials/v1/NCT03416179/registered?page=2