Under 21, any sex, with Mixed Lineage Acute Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Relevant Toxicities Related to TherapySecondary· 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 hemorr
Grade 5: death
Group
Value
95% CI
Stratum 1: Myeloid Malignancies
1
Stratum 2: ALL and MLM
3
Grade 4: sepsis
Group
Value
95% CI
Stratum 1: Myeloid Malignancies
0
Stratum 2: ALL and MLM
2
Grade 4: hemorrhage
Group
Value
95% CI
Stratum 1: Myeloid Malignancies
0
Stratum 2: ALL and MLM
1
Grade 4: hepatic toxicity
Group
Value
95% CI
Stratum 1: Myeloid Malignancies
0
Stratum 2: ALL and MLM
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded from a participant's on-study date until they were taken off study, up to 8 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 adverse events..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will test the safety and effectiveness of adding bortezomib and vorinostat to other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs have been approved by the Food and Drug Administration (FDA) to treat other cancers in adults, but they have not yet been approved tor treatment younger patients with leukemia.
PRIMARY OBJECTIVE
* To estimate the overall response rate of patients with MLL rearranged (MLLr) hematologic malignancies receiving bortezomib and vorinostat in combination with a chemotherapy backbone.
SECONDARY OBJECTIVES
* Estimate event-free and overall-survival.
* Describe toxicities experienced by participants during treatment.
OTHER PRESPECIFIED OBJECTIVES
* To identify all genomic lesions by comprehensive whole genome, exome and transcriptome sequencing on all patients.
* To compare minimal residual disease (MRD) results by three modalities: flow cytometry, polymerase chain reaction (PCR) and deep sequencing.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients
· Phase 1
· not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk
· Phase 2, PHASE3
· not yet recruiting
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
· Phase 2, PHASE3
· not yet recruiting
NCT07224672 — A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, an
· Phase 2
· not yet recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi
· Phase 3
· recruiting
Other recruiting trials for Mixed Lineage Acute Leukemia
Currently open trials in the same condition.
NCT04065399 — A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
· Phase 1, PHASE2
· recruiting
NCT04067336 — First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
· Phase 1, PHASE2
· recruiting
Other St. Jude Children's Research Hospital trials
Trials by the same sponsor.
NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma
· Phase 1
· recruiting
NCT07085338 — A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Pat
· Phase 2
· recruiting
NCT05664113 — Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction i
· Phase 1
· recruiting
NCT06993688 — Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit
· NA
· recruiting
NCT06326463 — CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
Last refreshed: 7 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02419755.