Trial · NCT01887587
Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia
NCT01887587, Phase 1, Terminated, Ehab L Atallah; results first posted 2020-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia. Trials, record NCT01887587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01887587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vincristine, Doxorubicin, And Dexamethasone + Ixazomib in Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma Or Mixed Phenotype Acute Leukemia
- NCT number
- NCT01887587
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- Ehab L Atallah
- Conditions
- Relapsed or Refractory Acute Lymphoblastic Leukemia, Relapsed or Refractory Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia
- Interventions
- MLN9708, Vincristine, Doxorubicin, Dexamethasone
- First posted
- 2013-06-27
- Last updated
- 2020-01-22
- Results first posted
- 2020-01-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events. | Baseline to 30 days post treatment; approximately 8 weeks | Safety, tolerability will be assessed by counting the number of participants experiencing adverse events at 8 weeks post treatment. |
| Primary | Optimal Dose of MLN9708 | 8 Weeks | This measure will be the maximum tolerated dose (MTD) at which no more than 1 Dose Limiting Toxicity (DLT) is observed. The starting dose of MLN9708 will be 2.3 mg orally on days 1, 8 and 15. If no DLT is seen in the first 3 patients, the dose will be increased to 3 mg and then to 4 mg orally on days 1, 8 and 15 in a classic 3 +3 phase I design. We will not attempt to increase the dose beyond 4 mg orally which, if achieved with acceptable toxicity, would be accepted as the recommended phase 2 dose (RP2D). 0 of 3 DLTs would allow escalation to the next dose level. 1 of 3 DLTs will require expanding to six patients; 1 of 6 DLTs will allow escalation again. 2 DLTs will require dose de-escalation. |
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 | Adverse Events. | Baseline to 30 days post treatment; approximately 8 weeks | At dose level one, 3 patients who were enrolled. The protocol was amended to remove PEGaspargase from the regimen. Two additional patients were enrolled on dose level one. | participants | NUMBER |
| PRIMARY | Optimal Dose of MLN9708 | 8 Weeks | All five subjects received the same 2.3 mg oral dose of MLN9708. | mg | 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 |
|---|---|---|---|---|---|
| Adverse Events. | (Modified VXLD) Plus MLN9708 | 5 | participants | ||
| Optimal Dose of MLN9708 | Modified VXLD Plus MLN9708 | 2.3 | mg |
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 | (Modified VXLD) Plus MLN9708 | 5 | |
| Overall Study | COMPLETED | (Modified VXLD) Plus MLN9708 | 5 | |
| Overall Study | NOT COMPLETED | (Modified VXLD) Plus MLN9708 | 0 |
Source ClinicalTrials.gov
Adverse events7
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 |
|---|---|---|---|---|---|---|
| serious | Febrile neutropenia | Blood and lymphatic system disorders | (Modified VXLD) Plus MLN9708 | 1 | 5 | |
| serious | Sepsis | Infections and infestations | (Modified VXLD) Plus MLN9708 | 3 | 5 | |
| serious | Methemoglobinemia | Investigations | (Modified VXLD) Plus MLN9708 | 1 | 5 | |
| serious | Sinus tachycardia | Cardiac disorders | (Modified VXLD) Plus MLN9708 | 1 | 5 | |
| serious | Lactic acidosis | Hepatobiliary disorders | (Modified VXLD) Plus MLN9708 | 1 | 5 | |
| serious | Increased blood bilirubin | Hepatobiliary disorders | (Modified VXLD) Plus MLN9708 | 1 | 5 | |
| serious | Hypotension | Vascular disorders | (Modified VXLD) Plus MLN9708 | 1 | 5 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (Modified VXLD) Plus MLN9708 | 1 | 5 |
| Total, other adverse events | (Modified VXLD) Plus MLN9708 | 0 | 5 |
| Total, serious adverse events | (Modified VXLD) Plus MLN9708 | 4 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT01887587
GET https://conductscience.org/api/trials/v1/NCT01887587/registered