drugset
drugset / Trial / NCT02043587

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

NCT02043587 ↗

Phase 2 Terminated 31 enrolled University of California, San Diego Leadiant Biosciences, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2022-04-14
Completion
2022-04-14

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject 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 Unknown 1.4 mg/m2 Intravenous
Subject 140 mg orally daily if BCR/ABL positive and/or Ph+ Unknown 140 mg Oral
Subject 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 Unknown 1000 iu Intravenous
Subject 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 Unknown 2000 iu Intravenous
Subject 2,000 mg/m2 IV, days 1-4 during Courses 1C & 2C Unknown 2000 mg/m2 Intravenous
Subject 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 Unknown 20 mg/m2 Intravenous
Subject 25 mg intrathecal (IT), on days 1 & 15 during Courses 1A & 2A; 50 mg intrathecal on day 1 during Maintenance Months 1 through 4 Unknown 50 mg Intrathecal
Subject 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 Unknown 375 mg/m2 Intravenous
Subject 500 mg/m2 IV over 3 hours once daily on days 1-4 during Courses 1C & 2C Unknown 500 mg/m2 Intravenous
Subject 60 mg/m2 orally once daily on days 1-28 during Courses 1A & 2A; Maintenance: Monthly, days 1-5 Unknown 60 mg/m2 Oral
Subject 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 Unknown 500 mg/m2 Intravenous
Subject 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 Unknown 750 mg/m2 Intravenous
Subject Daunorubicin 60 mg/m2 IV (in the vein) daily 1,2,3 Courses 1A, 2A Unknown 60 mg/m2 Intravenous
Subject Hydrocortisone Other / unclassified — —
Background 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 Unknown 10 mg/m2 Intravenous

Indications

acute lymphoblastic leukemia