Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma

Summary

The objective of this protocol is to improve survival for adults with acute lymphoblastic leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal cytarabine (Depocyt®) CNS prophylaxis.

Conditions

• Acute Lymphocytic Leukemia
• Adult Lymphoblastic Lymphoma

Interventions

DRUG

DNR

Daunorubicin 60 mg/m2 IV (in the vein) daily 1,2,3 Courses 1A, 2A

DRUG

VCR

1.4 mg/m2 IV, days 1, 8, 15, 22 (cap at 2mg for ages \>50) during Courses 1A, 2A; Maintenance: Day 1 during months 2-12

DRUG

PEG-asp

2,000 IU/m2 IV for ages \</= 50, age \> 50, 1000 IU/m2 IV Day 16, Courses 1A \& 2A; Day 18, Course 1B; Day 17, Course 2B; Day 16, Maintenance, Month 1

DRUG

CTX

750 mg/m2 IV, days 1 \&15 for subjects \<40 year of age, substitute cyclophosphamide 500 mg/m2 IV over 60 minutes every 12 hours for 4 doses on days 15 \& 16 for subjects \< 40 years of age if day 14 bone marrow M2 or M3; Courses 1A \& 2A

DRUG

Prednisone

60 mg/m2 orally once daily on days 1-28 during Courses 1A \& 2A; Maintenance: Monthly, days 1-5

DRUG

Liposomal AraC

25 mg intrathecal (IT), on days 1 \& 15 during Courses 1A \& 2A; 50 mg intrathecal on day 1 during Maintenance Months 1 through 4

DRUG

MTX

220 mg/m2 IV bolus over 15 minutes then 60 mg/m2/hour for 36 hours once on days 2-3 and 16-17 during Courses 1B \& 2B; 20 mg/m2 orally one day per week every 7 days during Maintenance Months

DRUG

LCV

50 mg/m2 IV over 15-30 minutes every 6 hours for 3 doses to begin immediately after completion of methotrexate infusion, then 10 mg/m2 orally or IV over 15-30 minutes every 6 hours until methotrexate level less than 0.1 micromolar during Courses 1B \& 2B

DRUG

AraC

2,000 mg/m2 IV, days 1-4 during Courses 1C \& 2C

DRUG

Etoposide

500 mg/m2 IV over 3 hours once daily on days 1-4 during Courses 1C \& 2C

DRUG

Dasatinib

140 mg orally daily if BCR/ABL positive and/or Ph+

DRUG

Rituximab

375 mg/m2 IV once daily on days 1 \& 15 (precursor B-cell ALL only, administer per institutional protocol) during Courses 1A, 1B, 1C \& 2A

DRUG

Hydrocortisone

Randomize patients proceeding to Course 1B to hydrocortisone versus placebo prior to PEG-asparaginase treatments in Courses 1B, 2B, 3B, and Maintenance month 1

Sponsors & Collaborators

• Leadiant Biosciences, Inc.

  collaborator INDUSTRY

• University of California, San Diego

  lead OTHER

Principal Investigators

• James K Mangan, MD, PhD · UC San Diego, Division of Blood and Marrow Transplantation

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2022-04-14

Completion

2022-04-14

Countries

• United States

Study Locations