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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lympho

Brief 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.

Detailed Summary:

This treatment regimen builds on the "Linker" regimen/UCSF Protocol 8707 ALL regimen backbone with the goal of improved efficacy and acceptable toxicity by substituting pegylated asparaginase for native L-asparaginase, the addition of rituximab for pre-B-cell ALL, and the addition of dasatinib for Philadelphia chromosome/BCR-ABL positive ALL, and the addition of cyclophosphamide for younger adults. In addition, the study regimen aims to reduce CNS relapse through the use of intrathecal liposomal cytarabine in place of intrathecal methotrexate for CNS relapse prophylaxis and

The regimen uses 3 modules of therapy with non-cross-resistant chemotherapy agents. Rituximab is added for a total of 8 doses for patients with pre-B-cell ALL. Dasatinib is added for patients with Ph+ ALL.

Course 1A (Induction): Daunorubicin, vincristine, PEG-asparaginase, and prednisone for all patients with the addition of cyclophosphamide for patients 18-39 years of age. Treatment is intensified for patients with disease present on a day 14 bone marrow biopsies during Induction Course 1A. In addition to standard analyses, minimal residual disease will be assessed on day 14 and remission bone marrow aspirates and correlated with outcomes.

Course 1B: High-dose methotrexate, oral 6-mercaptopurine, and PEG-asparaginase.

Course 1C: High-dose cytarabine and etoposide.

The 3 courses then repeat (2A (Intensification), 2B, 2C) followed by a final "B" cycle (3B) of high-dose methotrexate, 6-mercaptopurine, and PEG-asparaginase.

After completion of Course 3B, patients proceed to maintenance chemotherapy with monthly methotrexate, vincristine, 6-
Sponsor: University of California, San Diego

Current Primary Outcome: Event-free survival [ Time Frame: 3-year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Liposomal cytarabine toxicity [ Time Frame: 3 years ]
  • CNS relapse rate [ Time Frame: 3-year ]
  • Overall survival [ Time Frame: 3-year ]
  • Leukemia-free survival [ Time Frame: 3-year ]
  • Efficacy of hydrocortisone premedication for reduced PEG-asparaginase allergic reactions [ Time Frame: 3 years ]
  • PEG-asparaginase toxicities [ Time Frame: 3 years ]
  • Complete and overall response rates [ Time Frame: 3 years ]
  • Non-relapse mortality [ Time Frame: 3-year ]


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: January 21, 2014
Date Started: January 2014
Date Completion: January 2020
Last Updated: October 26, 2016
Last Verified: October 2016