Therapeutic Advances in Childhood Leukemia Consortium
Who can join
Adults 1 to 21, any sex, with Acute Lymphoblastic 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.
Occurrence of a Dose-Limiting Toxicity (Phase 1)Primary· Beginning with the first dose of investigational product until 30 days following the last dose of bortezomib
Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutro
Group
Value
95% CI
Ph 1, Dose Level 1 (1 mg/m2)
0
Ph 1, Dose Level 2 (1.3 mg/m2)
1
Ph 1, Dose Level 1 (1 mg/m2)
4
Ph 1, Dose Level 2 (1.3 mg/m2)
5
Achievement of Complete Remission (CR)Primary· Day 29 of Course 1
* Complete Remission (CR): M1 (\< 5% blasts) BM with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC\>750/uL and platelet count \>75 000/uL);
* Complete Remission without Platelet Recovery (CRp): M1 BM with no circulating blasts or extramedullary disease and recovery of ANC (\>750/uL) but insufficient recovery of platelets (\<75 000/uL).
* Partial Remission (PR): the disappearance of circulating blasts and achievement of M2 (5%-25% blasts) marrow status, without new sites of extramedullary disease, and with recovery of ANC (\>750/uL).
* S
Group
Value
95% CI
Ph 1 Dose Escalation
6
Ph 2 B-Precursor ALL Patients
14
Ph 2 T-Cell ALL Patients
0
Ph 1 Dose Escalation
0
Ph 2 B-Precursor ALL Patients
2
Ph 2 T-Cell ALL Patients
0
Ph 1 Dose Escalation
1
Ph 2 B-Precursor ALL Patients
0
Ph 2 T-Cell ALL Patients
2
Ph 1 Dose Escalation
1
Ph 2 B-Precursor ALL Patients
0
Ph 2 T-Cell ALL Patients
0
Bone Marrow ResponseSecondary· Day 29 of Course 1
M1: Less than 5% blasts in a bone marrow aspirate and at least 200 cells counted.
M2: 5-25% blasts in a bone marrow aspirate with at least 200 cells counted. M3: Greater than 25% blasts in a bone marrow aspirate with at least 200 cells counted.
Group
Value
95% CI
Phase 2 B-Precursor ALL Patients
17
Phase 2 T-cell ALL Patients
0
Phase 2 B-Precursor ALL Patients
0
Phase 2 T-cell ALL Patients
2
Phase 2 B-Precursor ALL Patients
3
Phase 2 T-cell ALL Patients
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
Publications & conference data
7 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 Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa
· Phase 1
· recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer
· Phase 2
· recruiting
NCT05621291 — A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Follo
· NA
· recruiting
NCT07356154 — A Study of Revumenib and Mezigdomide in People With Leukemia
· Phase 1, PHASE2
· recruiting
NCT07479927 — Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Alloge
· NA
· recruiting
Other Therapeutic Advances in Childhood Leukemia Consortium trials
Trials by the same sponsor.
NCT05476770 — Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
· Phase 1
· recruiting
NCT03825367 — Nivolumab in Combination With 5-azacytidine in Childhood Relapsed/Refractory AML
· Phase 1, PHASE2
· unknown
NCT03817320 — PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymph
· Phase 1, PHASE2
· active not recruiting
NCT03263936 — Epigenetic Reprogramming in Relapse/Refractory AML
· Phase 1
· completed
NCT02879643 — Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy
· Phase 1
· completed
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 Therapeutic Advances in Childhood Leukemia Consortium
Last refreshed: 19 February 2020
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/NCT00440726.