CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Bortezomib +6 moredrug
Likely dose
Bortezomib 1.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01769209
NCT01769209Phase 2Completed
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A Phase II Study of Subcutaneous Bortezomib in Combination With Chemotherapy (VXLD) for Relapsed/Refractory Adult Acute Lymphoblastic Leukemia

Stanford University·interventional·Posted Jan 16, 2013·Updated Nov 14, 2018

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Doxorubicin hydrochloride (HCl), and 5 other interventions for B-cell Adult Acute Lymphoblastic Leukemia (ALL) and 3 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This study evaluates the value of bortezomib in combination with specified chemotherapies for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Adult Acute Lymphoblastic Leukemia (ALL), Ph-positive Adult Acute Lymphoblastic Leukemia (ALL), Recurrent Adult Acute Lymphoblastic Leukemia (ALL), T-cell Adult Acute Lymphoblastic Leukemia (ALL)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 25, 2016
Study CompletionJul 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.5 years ago

Interventions

Bortezomibdrug

Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.

Doxorubicin hydrochloride (HCl)drug

Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.

PEG-Asparaginasedrug

Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.

Vincristine sulfatedrug

Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.

Dexamethasonedrug

Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.

Cytarabinedrug

Administered intrathecally (IT) at 100 mg, on Day 1

Methotrexatedrug

Administered intrathecally (IT) at 15 mg, on Day 15.