NCT01769209View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 25, 2016

Study Completion Date

July 4, 2017

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.

Trial Locations (1)

94305

Stanford University, School of Medicine, Stanford

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Stanford University

OTHER

NCT01769209 - Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter