MedTrace Logo

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT01769209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-11-14

Study results available
· View outcomes & findings →

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.

Conditions

  • B-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)

Interventions

DRUG

Bortezomib

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

DRUG

Doxorubicin hydrochloride (HCl)

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

DRUG

PEG-Asparaginase

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

DRUG

Vincristine sulfate

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

DRUG

Dexamethasone

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

DRUG

Cytarabine

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

DRUG

Methotrexate

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

Sponsors & Collaborators

Principal Investigators

  • Michaela Liedtke, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-11-25
Completion
2017-07-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769209 on ClinicalTrials.gov