Trial · NCT00381550
3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia
NCT00381550, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia. Trials, record NCT00381550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia
- NCT number
- NCT00381550
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Accelerated Phase Chronic Myelogenous Leukemia, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase Chronic Myelogenous Leukemia, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Essential Thrombocythemia, Philadelphia Chromosome Negative Chronic Myelogenous Leukemia, Polycythemia Vera, Primary Myelofibrosis, Relapsing Chronic Myelogenous Leukemia
- Interventions
- fludarabine phosphate, triapine, laboratory biomarker analysis
- First posted
- 2006-09-28
- Last updated
- 2015-01-06
- Results first posted
- 2014-05-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation | Up to 4 years | Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count \>500/mm3 and platelets \>20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.). |
| Primary | Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0 | Up to 4 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation | Up to 4 years | participants | NUMBER | |
| PRIMARY | Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0 | Up to 4 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation | Arm I | 18 | participants | ||
| Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0 | Arm I | 35 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triapine and Fludarabine Phosphate | 35 | |
| Overall Study | COMPLETED | Triapine and Fludarabine Phosphate | 35 | |
| Overall Study | NOT COMPLETED | Triapine and Fludarabine Phosphate | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Acidosis | Metabolism and nutrition disorders | Arm I | 10 | 35 | 10 |
| other | Allergic reaction | General disorders | Arm I | 5 | 35 | 5 |
| other | Anaphylaxis | General disorders | Arm I | 2 | 35 | 2 |
| other | Elevated bilirubin | Metabolism and nutrition disorders | Arm I | 14 | 35 | 14 |
| other | Elevated creatinine | Metabolism and nutrition disorders | Arm I | 8 | 35 | 8 |
| other | Fever | General disorders | Arm I | 11 | 35 | 11 |
| serious | Hyperbilirubinemia | Metabolism and nutrition disorders | Arm I | 2 | 35 | 2 |
| serious | Tumor Lysis syndrome | Metabolism and nutrition disorders | Arm I | 3 | 35 | 3 |
| serious | Infections | Infections and infestations | Arm I | 7 | 35 | 7 |
| serious | Kidney injury | Investigations | Arm I | 6 | 35 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, other adverse events | Arm I | 35 | 35 |
| Total, serious adverse events | Arm I | 18 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24362550 | RESULT |
Source PubMed
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 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/NCT00381550
GET https://conductscience.org/api/trials/v1/NCT00381550/registered