Trial · NCT03023046
Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT03023046, Phase 2, Completed, University of Washington; results first posted 2022-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Trials, record NCT03023046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03023046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT number
- NCT03023046
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- Interventions
- Cyclophosphamide, Dasatinib, Doxorubicin, Etoposide, Imatinib Mesylate, Laboratory Biomarker Analysis, Prednisone, Rituximab, Vincristine Sulfate
- First posted
- 2017-01-18
- Last updated
- 2022-07-13
- Results first posted
- 2022-07-13
- Limitations and caveats
- The sample sizes in this study are relatively small, making it difficult to draw definitive conclusions regarding response rate and survival with this regimen.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Morphological Complete Response Rate | Within 4 cycles of study therapy | Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as \<5% blasts by morphology, absolute neutrophil count \>1000/uL, and platelet count \>100,000/uL. |
| Primary | Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Within 4 cycles of study therapy | Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable. When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed. |
| Secondary | Number of Participants With Adverse Events | Within 28 days of the last dose of the study drugs | Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Overall Survival | Up to 2 years | Alive at 2 years after enrollment |
| Secondary | Event-free Survival | Up to 2 years | Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Morphological Complete Response Rate | Within 4 cycles of study therapy | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Within 4 cycles of study therapy | HTS- percentages were calculated after excluding patients (Ph+, n = 4; Ph-, n = 3) that were unable to have HTS testing performed for technical reasons. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Within 28 days of the last dose of the study drugs | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 2 years | Percentage of Participants | NUMBER | |
| SECONDARY | Event-free Survival | Up to 2 years | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Morphological Complete Response Rate | Ph+ Subjects | 27 | Participants | ||
| Number of Participants With Morphological Complete Response Rate | Ph- Subjects | 20 | Participants | ||
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph+ Subjects | MFC- / Achieve within 4 cycles | 20 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph- Subjects | MFC- / Achieve within 4 cycles | 16 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph+ Subjects | MFC- / Not achieved within 4 cycles | 8 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph- Subjects | MFC- / Not achieved within 4 cycles | 9 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph+ Subjects | CMR / Achieve within 4 cycles | 11 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph+ Subjects | CMR / Not achieved within 4 cycles | 17 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph+ Subjects | HTS- / Achieve within 4 cycles | 8 | Participants | |
| Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate | Ph- Subjects | HTS- / Achieve within 4 cycles | 6 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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) | 54 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy) | 53 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy) | 1 |
Source ClinicalTrials.gov
Adverse events32
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Chemotherapy) | 1 | 53 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Chemotherapy) | 1 | 53 | 1 |
| other | Edema limbs | General disorders | Treatment (Chemotherapy) | 1 | 53 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Chemotherapy) | 3 | 53 | 3 |
| other | Hypertension | Vascular disorders | Treatment (Chemotherapy) | 2 | 53 | 2 |
| other | Hypotension | Vascular disorders | Treatment (Chemotherapy) | 2 | 53 | 2 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Chemotherapy) | 5 | 53 | 6 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Treatment (Chemotherapy) | 1 | 53 | 1 |
| other | Sepsis | Infections and infestations | Treatment (Chemotherapy) | 1 | 53 | 1 |
| serious | Aspiration | Respiratory, thoracic and mediastinal disorders | Treatment (Chemotherapy) | 1 | 53 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy) | 18 | 53 |
| Total, other adverse events | Treatment (Chemotherapy) | 14 | 53 |
| Total, serious adverse events | Treatment (Chemotherapy) | 32 | 53 |
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ph+ Subjects vs Ph- Subjects: Number of Participants With Morphological Complete Response Rate |
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/NCT03023046
GET https://conductscience.org/api/trials/v1/NCT03023046/events?page=2