Trial · NCT01620216
Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
NCT01620216, Phase 2, Terminated, OHSU Knight Cancer Institute; results first posted 2021-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia. Trials, record NCT01620216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01620216
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
- NCT number
- NCT01620216
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia
- Interventions
Antitumor Drug Screening Assay, Dasatinib, Idelalisib, Laboratory Biomarker Analysis, Pacritinib, Pharmacological Study, Ponatinib, Ponatinib Hydrochloride, Ruxolitinib, Sorafenib, Sorafenib Tosylate, Sunitinib, Sunitinib Malate
- First posted
- 2012-06-15
- Last updated
- 2021-11-04
- Results first posted
- 2021-10-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Activity | Up to 28 days | Will be defined as defined as a decrease of at least 25% in bone marrow blast counts or peripheral blood blast. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented. |
| Secondary | Overall Objective Response Rates (Complete and Partial) | Up to 3 years | Per Response Evaluation Criteria in AML or ALL: Complete Response (CR), at least \<5% bone marrow blasts; Partial Response (PR), reduction of \>=50% bone marrow blasts; Overall Response (OR)= CR + PR. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented. |
| Secondary | Progression-free Survival | From the start of study drug treatment to death, regardless of cause of death, or date of disease progression defined as a >= 50% increase in leukemic bone marrow blasts, whichever occurs first, assessed up to 3 years | Kaplan-Meier method will be used to estimate the survival curve. |
| Secondary | Overall Survival | From the date of subject registration to death, regardless of causes of death, assessed up to 3 years | Kaplan-Meier method will be used to estimate the survival curve. |
| Secondary | Clinical Activity | Up to 28 days | Will be defined as a decrease of at least 25% in bone marrow blast counts or in peripheral blood blasts in subjects who have failed the initial inhibitor but are then treated with another inhibitor identified on repeat pre-clinical activity testing. The proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented. |
| Other | Presence of Active/Aberrant Kinase Pathways | Up to 3 years | Presence of active/aberrant kinase pathways will be determined using a small molecule kinase inhibitor screen, to rapidly identify therapeutic tyrosine kinase targets in leukemia patients while simultaneously providing individualized therapeutic options. Will be correlated with treatment response, mutational analysis using next generation sequencing, and characterization of aberrant gene expression in primary leukemia samples. |
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 | Clinical Activity | Up to 28 days | Zero patients enrolled in Ponatinib, Pacrtitinib, Ruxolitinib, and Idealisib arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Objective Response Rates (Complete and Partial) | Up to 3 years | Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | From the start of study drug treatment to death, regardless of cause of death, or date of disease progression defined as a >= 50% increase in leukemic bone marrow blasts, whichever occurs first, assessed up to 3 years | Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From the date of subject registration to death, regardless of causes of death, assessed up to 3 years | Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms. | Days | MEAN |
| SECONDARY | Clinical Activity | Up to 28 days | Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Presence of Active/Aberrant Kinase Pathways | Up to 3 years | Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Activity | Group I (Dasatinib) | 1 | Participants | ||
| Clinical Activity | Group II (Sutinib Malate) | 0 | Participants | ||
| Clinical Activity | Group III (Sorafenib Tosylate) | 4 | Participants | ||
| Overall Objective Response Rates (Complete and Partial) | Group I (Dasatinib) | Partial response | 0 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group II (Sutinib Malate) | Partial response | 0 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group III (Sorafenib Tosylate) | Partial response | 1 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group I (Dasatinib) | Progressive disease | 2 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group II (Sutinib Malate) | Progressive disease | 0 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group III (Sorafenib Tosylate) | Progressive disease | 0 | Participants | |
| Overall Objective Response Rates (Complete and Partial) | Group I (Dasatinib) | Stable disease | 2 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I (Dasatinib) | 4 | |
| Overall Study | STARTED | Group II (Sutinib Malate) | 2 | |
| Overall Study | STARTED | Group III (Sorafenib Tosylate) | 6 | |
| Overall Study | STARTED | Group IV (Ponatinib Hydrochloride) | 0 | |
| Overall Study | STARTED | Group V (Pacritinib) | 0 | |
| Overall Study | STARTED | Group VI (Ruxolitinib) | 0 | |
| Overall Study | STARTED | Group VII (Idelalisib) | 0 | |
| Overall Study | COMPLETED | Group I (Dasatinib) | 4 | |
| Overall Study | COMPLETED | Group II (Sutinib Malate) | 2 | |
| Overall Study | COMPLETED | Group III (Sorafenib Tosylate) | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events273
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 | Acute kidney injury | Renal and urinary disorders | Group I (Dasatinib) | 0 | 4 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Group II (Sunitinib Malate) | 0 | 2 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Group III (Sorafenib Tosylate) | 1 | 6 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Group IV (Ponatinib Hydrochloride) | 0 | ||
| other | Acute kidney injury | Renal and urinary disorders | Group V (Pacritinib) | 0 | ||
| other | Acute kidney injury | Renal and urinary disorders | Group VI (Ruxolitinib) | 0 | ||
| other | Acute kidney injury | Renal and urinary disorders | Group VII (Idelalisib) | 0 | ||
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group I (Dasatinib) | 1 | 4 | 1 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group II (Sunitinib Malate) | 0 | 2 | 0 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group III (Sorafenib Tosylate) | 0 | 6 | 0 |
1 to 10 of 273Source ClinicalTrials.gov
See all 273 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I (Dasatinib) | 0 | 4 |
| Total, all-cause mortality | Group II (Sunitinib Malate) | 0 | 2 |
| Total, all-cause mortality | Group III (Sorafenib Tosylate) | 0 | 6 |
| Total, all-cause mortality | Group IV (Ponatinib Hydrochloride) | 0 | 0 |
| Total, all-cause mortality | Group V (Pacritinib) | 0 | 0 |
| Total, all-cause mortality | Group VI (Ruxolitinib) | 0 | 0 |
| Total, all-cause mortality | Group VII (Idelalisib) | 0 | 0 |
| Total, other adverse events | Group I (Dasatinib) | 3 | 4 |
| Total, other adverse events | Group II (Sunitinib Malate) | 0 | 2 |
| Total, other adverse events | Group III (Sorafenib Tosylate) | 6 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 |
|---|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 | NIH RePORTER |
| R21CA159265 | A Phase II proof-of-concept trial to study kinase inhibition in relapsed/refracto | LORIAUX, MARC MAURICE | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2011 to 2012 | 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/NCT01620216
GET https://conductscience.org/api/trials/v1/NCT01620216/results?page=2