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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT02043587
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Lymphocytic Leukemia
  • Adult Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • DNR — DRUG
    Daunorubicin 60 mg/m2 IV (in the vein) daily 1,2,3 Courses 1A, 2A
  • VCR — DRUG
    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
  • PEG-asp — DRUG
    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
  • CTX — DRUG
    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
  • Prednisone — DRUG
    60 mg/m2 orally once daily on days 1-28 during Courses 1A \& 2A; Maintenance: Monthly, days 1-5
  • Liposomal AraC — DRUG
    25 mg intrathecal (IT), on days 1 \& 15 during Courses 1A \& 2A; 50 mg intrathecal on day 1 during Maintenance Months 1 through 4
  • MTX — DRUG
    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
  • LCV — DRUG
    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
  • AraC — DRUG
    2,000 mg/m2 IV, days 1-4 during Courses 1C \& 2C
  • Etoposide — DRUG
    500 mg/m2 IV over 3 hours once daily on days 1-4 during Courses 1C \& 2C
  • Dasatinib — DRUG
    140 mg orally daily if BCR/ABL positive and/or Ph+
  • Rituximab — DRUG
    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
  • Hydrocortisone — DRUG
    Randomize patients proceeding to Course 1B to hydrocortisone versus placebo prior to PEG-asparaginase treatments in Courses 1B, 2B, 3B, and Maintenance month 1

Study Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
Apr 2022
Primary completion
Apr 14, 2022
Completion
Apr 14, 2022

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy for ALL
    Course 1A: DNR 60 mg/m2 IV d1,2,3; VCR 1.4 mg/m2 d1,8,15,22 (cap 2 mg age \>50); PEG-asp 2000 IU/m2 IV d16, age \>50 1000 IU/m2, cap 3750 IU/m2; CTX 750 mg/m2 d1,15 age \< 40; Prednisone 60 mg/m2 PO d1-28; Liposomal AraC 25 mg IT d1, 15 1B: MTX 220 mg/m2 IV then 60 mg/m2/h for 36h d2-3,d16-17; LCV 50 mg/m2 IV q6h x3 then 10 mg/m2 PO/IV q6h til MTX \<0.1 uM; 6-MP 60 mg/m2 PO d2-8, d16-22; PEG-asp 2000 IU/m2 IV d18, age \>50 1000 IU/m2, cap 3750 IU/m2 1C: AraC 2 g/m2 IV d1-4; Etoposide 500 mg/m2 IV d1-4 1A-C repeat x1(2A-C) then 3rd Course B (3B) Maintenance (monthly, 24 mo): Prednisone 60 mg/m2 PO d1-5; VCR 1.4 mg/m2 IV d1 (cap 2 mg age \>50); MTX 20 mg/m2 PO wkly; 6-MP 60 mg/m2 PO qd PEG-asp 2000 IU/m2 IV d16, age \>50 1000 IU/m2, cap 3,750 IU/m2 (Mo. 1) Maintenance mo. 1-4: Liposomal AraC 50 mg IT d1 Dasatinib 140 mg PO qd if Ph/BCR-ABL+; Rituximab 375 mg/m2 IV d1,15 of 1A-C, 2A (Pre-B) 1:1 randomization: hydrocortisone v. placebo before PEG-asp 1B, 2B, \& Maint.

Primary Outcome Measure

Event-free survival [ Time Frame: 3-year ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCSD, Division of Blood and Marrow Transplantation, Moores Cancer CenterLa JollaCalifornia92093-
Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCSF Comprehensive Cancer CenterSan FranciscoCalifornia94143-0324-

Find similar trials in La Jolla, CA

By research site
UCSD, Division of Blood and Marrow Transplantation, Moores Cancer Center· La Jolla, CAHematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLA· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCSF Comprehensive Cancer Center· San Francisco, CA

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