Trial · NCT02419755

Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies

NCT02419755, Phase 2, Terminated, St. Jude Children's Research Hospital; results first posted 2018-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies. Trials, record NCT02419755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02419755

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies
NCT number: NCT02419755
Status: Terminated
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Mixed Lineage Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Interventions: Bortezomib, Vorinostat, Mitoxantrone, Cytarabine, Methotrexate, Hydrocortisone, Peg-L-Asparaginase, Erwinia L-Asparaginase, Dexamethasone, Mercaptopurine, Doxorubicin
First posted: 2015-04-17
Last updated: 2018-03-07
Results first posted: 2018-02-01
Limitations and caveats: The study was terminated early, because accrual goals were no longer feasible based on restrictions imposed by the Data Safety Monitoring Board (DSMB).

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate in All Participants	End of first treatment block (up to 2 months)	For the purpose of the statistical analysis of the primary objective, response is assessed at the end of first treatment block at maximum tolerated dose of vorinostat (i.e., Induction Ia or Ib for myeloid and Induction for lymphoid and mixed lineage). Any eligible patient who starts first treatment block is considered evaluable. Response of CR, CRi, PR, or PRi is considered a success; otherwise a failure, which will include the cases of No-response, as well as off- treatment or off-study before response can be assessed, except cases found ineligible after enrollment. A patient found ineligible after enrollment will be taken off study and replaced by enrolling an additional MLLr patient. The rate (probability) of response will be estimated by the sample proportion of patients who responded (CR, CRi, PR, PRi) to Induction, along with the 99% confidence interval and lower confidence bound. Three interim analyses will be performed to monitor the possible lack of efficacy.
Secondary	Number of Participants With 3 Year Event Free Survival (EFS)	Three years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Participants With 5- Year Event Free Survival	Five years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Participant With 10-year Event Free Survival	Ten years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Participants With 3-year Overall Survival (OS)	Three years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Participants With 5-year Overall Survival	Five years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Participants With 10-year Overall Survival	Ten years after the last enrollment	All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure. Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals.
Secondary	Number of Relevant Toxicities Related to Therapy	From on-therapy date up to 18 months	Events were graded using CTCAE v. 4.0. All toxicities will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for toxicity, as any further toxicities may be secondary to the transplant and not the study regimen. This outcome reports those toxicities that are that were possibly, probably or definitely related to therapy. Participants were separately monitored for frequency of grade 5 events, grade 4 sepsis, grade 4 hemorrhage, and grade 4 hepatic toxicity across all patients in the stratum. Grade 4 and 5 events that are clearly and incontrovertibly due to extraneous causes or disease progression will be excluded. Higher grade events are considered more severe than lower grade.
Other	Frequency of Identified Genomic Lesions	Once at enrollment	Frequencies of the identified lesions will be described by counts and proportions. An established method (Pounds et al., 2013) will be applied to identify genes and pathways frequently hit by the genomic lesions.
Other	Minimal Residual Disease (MRD)	Various time points until completion of therapy (up to 18 months)	MRD will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for minimal residual disease. Concordance and associations of the MRD levels across three modalities (flow cytometry, PCR, and deep sequencing) as continuous measurements will be assessed by Pearson's and Spearman's correlations and Kendall's tau; MRD levels categorized into ordinal values will be analyzed by contingency tables with or without ordered margins.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate in All Participants	End of first treatment block (up to 2 months)	The determination of overall response rate is contingent on the determination of the maximum tolerated dose. The study was terminated before the maximum tolerated dose was determined. Therefore, response rate cannot be calculated.
SECONDARY	Number of Participants With 3 Year Event Free Survival (EFS)	Three years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Participants With 5- Year Event Free Survival	Five years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Participant With 10-year Event Free Survival	Ten years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Participants With 3-year Overall Survival (OS)	Three years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Participants With 5-year Overall Survival	Five years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Participants With 10-year Overall Survival	Ten years after the last enrollment	All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.
SECONDARY	Number of Relevant Toxicities Related to Therapy	From on-therapy date up to 18 months	Although only 3 Stratum 1 and 4 Stratum 2 participants completed the trial, there were 4 Stratum 1 participants and 6 Stratum 2 participants evaluable for this outcome measures.	events	NUMBER
OTHER_PRE_SPECIFIED	Frequency of Identified Genomic Lesions	Once at enrollment	The investigator is unable to identify frequency of genomic lesions. To obtain useful information, a much larger sample size is needed. Genomic sequencing is cost-prohibitive to be performed on this small sample size where there are too few samples to obtain any useful information.
OTHER_PRE_SPECIFIED	Minimal Residual Disease (MRD)	Various time points until completion of therapy (up to 18 months)	Data was either not collected or is incomplete for each of the 10 participants, and therefore cannot be analyzed.

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Relevant Toxicities Related to Therapy	Stratum 1: Myeloid Malignancies	Grade 5: death	1	events
Number of Relevant Toxicities Related to Therapy	Stratum 2: ALL and MLM	Grade 5: death	3	events
Number of Relevant Toxicities Related to Therapy	Stratum 1: Myeloid Malignancies	Grade 4: sepsis	0	events
Number of Relevant Toxicities Related to Therapy	Stratum 2: ALL and MLM	Grade 4: sepsis	2	events
Number of Relevant Toxicities Related to Therapy	Stratum 1: Myeloid Malignancies	Grade 4: hemorrhage	0	events
Number of Relevant Toxicities Related to Therapy	Stratum 2: ALL and MLM	Grade 4: hemorrhage	1	events
Number of Relevant Toxicities Related to Therapy	Stratum 1: Myeloid Malignancies	Grade 4: hepatic toxicity	0	events
Number of Relevant Toxicities Related to Therapy	Stratum 2: ALL and MLM	Grade 4: hepatic toxicity	0	events

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1: Myeloid Malignancies	6
Overall Study	STARTED	Stratum 2: ALL and MLM	6
Overall Study	COMPLETED	Stratum 1: Myeloid Malignancies	3
Overall Study	COMPLETED	Stratum 2: ALL and MLM	2
Overall Study	NOT COMPLETED	Stratum 1: Myeloid Malignancies	3
Overall Study	NOT COMPLETED	Stratum 2: ALL and MLM	4

Source ClinicalTrials.gov

Adverse events176

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	Stratum 1: Myeloid Malignancies	0	4	0
other	Abdominal pain	Gastrointestinal disorders	Stratum 2: ALL and MLM	1	6	1
other	Acidosis	Metabolism and nutrition disorders	Stratum 1: Myeloid Malignancies	1	4	4
other	Acidosis	Metabolism and nutrition disorders	Stratum 2: ALL and MLM	1	6	1
other	Acute kidney injury	Renal and urinary disorders	Stratum 1: Myeloid Malignancies	1	4	2
other	Acute kidney injury	Renal and urinary disorders	Stratum 2: ALL and MLM	0	6	0
other	Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Stratum 1: Myeloid Malignancies	1	4	1
other	Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Stratum 2: ALL and MLM	0	6	0
other	Agitation	Psychiatric disorders	Stratum 1: Myeloid Malignancies	0	4	0
other	Agitation	Psychiatric disorders	Stratum 2: ALL and MLM	1	6	1

1 to 10 of 176Source ClinicalTrials.gov

See all 176 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum 1: Myeloid Malignancies	4	4
Total, all-cause mortality	Stratum 2: ALL and MLM	6	6
Total, other adverse events	Stratum 1: Myeloid Malignancies	4	4
Total, other adverse events	Stratum 2: ALL and MLM	6	6
Total, serious adverse events	Stratum 1: Myeloid Malignancies	1	4
Total, serious adverse events	Stratum 2: ALL and MLM	2	6

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Stratum 1: Myeloid Malignancies vs Stratum 2: ALL and MLM: deaths from any cause	Trial comparisons
Stratum 1: Myeloid Malignancies vs Stratum 2: ALL and MLM: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02419755

GET https://conductscience.org/api/trials/v1/NCT02419755/events?page=2

API reference For AI assistants