Trial · NCT01101880
Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm
NCT01101880, Phase 2, Completed, University of Washington; results first posted 2017-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm. Trials, record NCT01101880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101880
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm
- NCT number
- NCT01101880
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Untreated Adult Acute Myeloid Leukemia, Myeloproliferative Neoplasm With 10% Blasts or Higher
- Interventions
- filgrastim, clofarabine, cytarabine
- First posted
- 2010-04-12
- Last updated
- 2017-10-19
- Results first posted
- 2017-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Up to 5 years | With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL). |
| Primary | Duration of Remission | Up to 5 years | With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues). |
| Primary | Time to Progression | Up to 5 years | With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. |
| Primary | Event Free Survival | Up to 5 years | Number of patients in remission at a median follow up of 15 months. |
| Primary | Treatment-related Mortality (TRM) | Up to 5 years | Treatment-related mortality (TRM) data was not collected. |
| Primary | Overall Survival | Up to 5 years | With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Up to 5 years | CR achieved with no AHD only applies to those who did not have AHD. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of Remission | Up to 5 years | weeks | MEDIAN | |
| PRIMARY | Time to Progression | Up to 5 years | weeks | MEDIAN | |
| PRIMARY | Event Free Survival | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Treatment-related Mortality (TRM) | Up to 5 years | Treatment-related mortality (TRM) data was not collected. | ||
| PRIMARY | Overall Survival | Up to 5 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved | 38 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with first course of induction | 33 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR + CRp achieved | 41 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with no AHD | 23 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with AHD | 15 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR + CRp achieved with AHD | 18 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with FLT3 positive | 7 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with favorable risk cytogenetics | 4 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR achieved with intermediate risk cytogenetics | 26 | Participants | |
| Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts | Treatment (Chemotherapy and Colony Stimulating Factor) | CR + CRp achieved with intermediate risk cyto. | 27 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Chemotherapy and Colony Stimulating Factor) | 50 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy and Colony Stimulating Factor) | 50 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy and Colony Stimulating Factor) | 0 |
Source ClinicalTrials.gov
Adverse events13
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 |
|---|---|---|---|---|---|---|
| serious | infection | Infections and infestations | Treatment (Chemotherapy and Colony Stimulating Factor) | 50 | 50 | 95 |
| serious | Pulmonary | Respiratory, thoracic and mediastinal disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 31 | 50 | 31 |
| serious | Liver enzymes | Hepatobiliary disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 20 | 50 | 20 |
| serious | Gastrointestinal | Gastrointestinal disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 10 | 50 | 10 |
| serious | Metabolic | Metabolism and nutrition disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 10 | 50 | 10 |
| serious | Dermatologic | Skin and subcutaneous tissue disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 10 | 50 | 10 |
| serious | Neurologic | Nervous system disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 6 | 50 | 6 |
| serious | Coagulation | Blood and lymphatic system disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 4 | 50 | 4 |
| serious | Cardiovascular | Cardiac disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 2 | 50 | 2 |
| serious | Ocular | Eye disorders | Treatment (Chemotherapy and Colony Stimulating Factor) | 1 | 50 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy and Colony Stimulating Factor) | ||
| Total, other adverse events | Treatment (Chemotherapy and Colony Stimulating Factor) | 0 | 0 |
| Total, serious adverse events | Treatment (Chemotherapy and Colony Stimulating Factor) | 50 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25545153 | 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 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/NCT01101880
GET https://conductscience.org/api/trials/v1/NCT01101880/registered