Trial · NCT01303796
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01303796, Phase 3, Completed, Cyclacel Pharmaceuticals, Inc.; results first posted 2022-06-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT01303796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01303796
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT01303796
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 482 participants, actual
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Sapacitabine, Decitabine
- First posted
- 2011-02-25
- Last updated
- 2022-06-22
- Results first posted
- 2022-06-22
- Limitations and caveats
- Point to note: The Lead-in AML patients in the sapacitabine-decitabine alternate dosing arm (n=21) were not considered for efficacy assessment.
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 | up to 43 months | The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival. |
| Secondary | Complete Remission (CR) | up to 43 months | Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
| Secondary | Complete Remission With Incomplete Platelet Count Recovery (CRp) | up to 43 months | Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
| Secondary | Partial Remission (PR) | up to 43 months | Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
| Secondary | Hematological Improvement | up to 43 months | HI with duration (HI) 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
| Secondary | Stable Disease (SD) | up to 43 months | Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks. |
| Secondary | Blood Products Transfused | up to 43 months | Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation. |
| Secondary | Hospitalized Days | up to 12 months | In-patient days in hospital. |
| Secondary | 1-year Survival | Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage). | One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization. |
| Secondary | Duration of Complete Remission (dCR) | up to 43 months | Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
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 | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Months | MEDIAN |
| SECONDARY | Complete Remission (CR) | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Remission With Incomplete Platelet Count Recovery (CRp) | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Partial Remission (PR) | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hematological Improvement | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stable Disease (SD) | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blood Products Transfused | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Pint | MEDIAN |
| SECONDARY | Hospitalized Days | up to 12 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | Days | MEDIAN |
| SECONDARY | 1-year Survival | Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage). | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Complete Remission (dCR) | up to 43 months | Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Sapacitabine-decitabine Alternating | 5.9 | 95% Confidence Interval 4.7 to 8.0 | Months | |
| Overall Survival | Decitabine | 5.7 | 95% Confidence Interval 4.9 to 8.2 | Months | |
| Complete Remission (CR) | Sapacitabine-decitabine Alternating | Responders | 40 | Participants | |
| Complete Remission (CR) | Decitabine | Responders | 26 | Participants | |
| Complete Remission (CR) | Sapacitabine-decitabine Alternating | Non-Responders | 198 | Participants | |
| Complete Remission (CR) | Decitabine | Non-Responders | 213 | Participants | |
| Complete Remission (CR) | Sapacitabine-decitabine Alternating | Missing | 3 | Participants | |
| Complete Remission (CR) | Decitabine | Missing | 2 | Participants | |
| Complete Remission With Incomplete Platelet Count Recovery (CRp) | Sapacitabine-decitabine Alternating | Responders | 5 | Participants | |
| Complete Remission With Incomplete Platelet Count Recovery (CRp) | Decitabine | Responders | 5 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead In Phase | STARTED | Lead In Phase | 21 | |
| Lead In Phase | STARTED | Sapacitabine-decitabine Alternating | 0 | |
| Lead In Phase | STARTED | Decitabine | 0 | |
| Lead In Phase | COMPLETED | Lead In Phase | 21 | |
| Lead In Phase | COMPLETED | Sapacitabine-decitabine Alternating | 0 | |
| Lead In Phase | COMPLETED | Decitabine | 0 | |
| Lead In Phase | NOT COMPLETED | Lead In Phase | 0 | |
| Lead In Phase | NOT COMPLETED | Sapacitabine-decitabine Alternating | 0 | |
| Lead In Phase | NOT COMPLETED | Decitabine | 0 | |
| Randomized Phase III | STARTED | Lead In Phase | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events366
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 | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Lead In Phase | 0 | ||
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Sapacitabine-decitabine Alternating | 136 | 236 | 4,020 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Decitabine | 129 | 233 | 3,745 |
| other | ANAEMIA | Blood and lymphatic system disorders | Lead In Phase | 0 | ||
| other | ANAEMIA | Blood and lymphatic system disorders | Sapacitabine-decitabine Alternating | 127 | 236 | 4,020 |
| other | ANAEMIA | Blood and lymphatic system disorders | Decitabine | 119 | 233 | 3,745 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Lead In Phase | 0 | ||
| other | NEUTROPENIA | Blood and lymphatic system disorders | Sapacitabine-decitabine Alternating | 107 | 236 | 4,020 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Decitabine | 88 | 233 | 447 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Lead In Phase | 0 |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lead In Phase | 21 | 21 |
| Total, all-cause mortality | Sapacitabine-decitabine Alternating | 221 | 241 |
| Total, all-cause mortality | Decitabine | 211 | 241 |
| Total, other adverse events | Lead In Phase | 0 | 0 |
| Total, other adverse events | Sapacitabine-decitabine Alternating | 236 | 236 |
| Total, other adverse events | Decitabine | 232 | 233 |
| Total, serious adverse events | Lead In Phase | 17 | 21 |
| Total, serious adverse events | Sapacitabine-decitabine Alternating | 199 | 236 |
| Total, serious adverse events | Decitabine | 188 | 233 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34424530 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sapacitabine-decitabine Alternating vs Decitabine: 1-year Survival |
Source 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/NCT01303796
GET https://conductscience.org/api/trials/v1/NCT01303796/results?page=2