Trial · NCT02135874
Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
NCT02135874, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia. Trials, record NCT02135874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135874
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
- NCT number
- NCT02135874
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Undifferentiated Leukemia, Mixed Phenotype Acute Leukemia, Mixed Phenotype Acute Leukemia, B/Myeloid, Not Otherwise Specified, Mixed Phenotype Acute Leukemia, T/Myeloid, Not Otherwise Specified, Recurrent Mixed Phenotype Acute Leukemia
- Interventions
- Clofarabine, Cytarabine, Dexamethasone, Idarubicin, Rituximab, Sorafenib, Sorafenib Tosylate, Vincristine, Vincristine Sulfate
- First posted
- 2014-05-12
- Last updated
- 2024-03-22
- Results first posted
- 2024-03-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Complete Response | Up to 2 months | Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia. |
| Secondary | 4-week Mortality Rate | At 4 weeks | Number of participants who died after 4 weeks of treatment. |
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 | Participants Complete Response | Up to 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 4-week Mortality Rate | At 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Participants Complete Response | Treatment (Combination Chemotherapy) | 9 | Participants | ||
| 4-week Mortality Rate | Treatment (Combination Chemotherapy) | 1 | 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 | Treatment (Combination Chemotherapy) | 16 | |
| Overall Study | COMPLETED | Treatment (Combination Chemotherapy) | 16 | |
| Overall Study | NOT COMPLETED | Treatment (Combination Chemotherapy) | 0 |
Source ClinicalTrials.gov
Adverse events66
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 | Diaphoresis | Skin and subcutaneous tissue disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Hiccups | Respiratory, thoracic and mediastinal disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Fluid Imbalance | General disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Indigestion | Gastrointestinal disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Hypotension | Vascular disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Bradycardia | Cardiac disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Treatment (Combination Chemotherapy) | 1 | 16 | 1 |
| other | Transaminitis | Metabolism and nutrition disorders | Treatment (Combination Chemotherapy) | 5 | 16 | 5 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Combination Chemotherapy) | 3 | 16 |
| Total, other adverse events | Treatment (Combination Chemotherapy) | 16 | 16 |
| Total, serious adverse events | Treatment (Combination Chemotherapy) | 11 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source 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/NCT02135874
GET https://conductscience.org/api/trials/v1/NCT02135874/events?page=2