Trial · NCT00795002
Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00795002, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT00795002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00795002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT00795002
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), 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(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Interventions
- alvocidib, mitoxantrone hydrochloride, cytarabine, pharmacological study, laboratory biomarker analysis
- First posted
- 2008-11-21
- Last updated
- 2018-08-07
- Results first posted
- 2013-12-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response | 1 year | Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR. |
| Secondary | Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM | 60 days | Toxicity defined as death from any cause within 60 days of starting FLAM. |
| Secondary | Disease-free Survival | up to 2 years | This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response | 1 year | 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM | 60 days | 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease-free Survival | up to 2 years | 39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response | Arm I | 24 | participants | ||
| Complete Response | Arm II | 29 | participants | ||
| Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM | Arm I | 3 | Participants | ||
| Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM | Arm II | 3 | Participants | ||
| Disease-free Survival | Arm I | 13.6 | 95% Confidence Interval 10.1 to NA | months | |
| Disease-free Survival | Arm II | 12.0 | 95% Confidence Interval 9.2 to NA | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I | 37 | |
| Overall Study | STARTED | Arm II | 37 | |
| Overall Study | COMPLETED | Arm I | 37 | |
| Overall Study | COMPLETED | Arm II | 37 | |
| Overall Study | NOT COMPLETED | Arm I | 0 | |
| Overall Study | NOT COMPLETED | Arm II | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | General disorders-other | General disorders | Arm I | 1 | 39 | 1 |
| other | General disorders-other | General disorders | Arm II | 1 | 39 | 1 |
| serious | Tumor Lysis Syndrome | Metabolism and nutrition disorders | Arm I | 4 | 39 | 4 |
| serious | Tumor Lysis Syndrome | Metabolism and nutrition disorders | Arm II | 4 | 39 | 4 |
| serious | Oral and/or Gastrointestinal mucositis | Gastrointestinal disorders | Arm I | 2 | 39 | 2 |
| serious | Oral and/or Gastrointestinal mucositis | Gastrointestinal disorders | Arm II | 2 | 39 | 2 |
| serious | Cardiac dysfunction | Cardiac disorders | Arm I | 2 | 39 | 2 |
| serious | Cardiac dysfunction | Cardiac disorders | Arm II | 2 | 39 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, all-cause mortality | Arm II | ||
| Total, other adverse events | Arm I | 1 | 39 |
| Total, other adverse events | Arm II | 1 | 39 |
| Total, serious adverse events | Arm I | 8 | 39 |
| Total, serious adverse events | Arm II | 8 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA070095 | Phase I Clinical Trials of New Anti-Cancer Targeted Therapies | CARDUCCI, MICHAEL A | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I vs Arm II: Complete Response | Trial comparisons |
| Arm I vs Arm II: Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM | Trial comparisons |
| Arm I vs Arm II: 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/NCT00795002
GET https://conductscience.org/api/trials/v1/NCT00795002/registered