NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Condition: Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Prednisone; Vincristine; Daunorubicin; PEG-asparaginase; Erwinia asparaginase; Doxorubicin; Cyclophosphamide; Cytarabine; Thioguanine; Clofarabine; Methotrexate; Mercaptopurine; Dexamethasone; Hydrocortisone; Etoposide
Intervention description: Given orally (PO).; Given intravenously (IV).; Given IV.; Given intramuscularly (IM) or IV.; Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.; Given IV.; Given IV.; Given IV or IT.; Given PO.; Given IV.; Given IV, IM or IT.; Given PO.; Given PO or IV.; Given IT.; Given IV.
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Prednisolone; Hydrocortisone; Cyclophosphamide; Doxorubicin; Methotrexate; Etoposide; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Clofarabine; Pegaspargase; Thioguanine; Antimetabolites
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Lymphoblastic lymphoma

Summary:

      This is a phase II clinical trial using risk-adapted therapy. The treatment is acute
      lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of
      induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months.
      Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral
      blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone
      marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma.

      The Primary Objective of this study is:

      To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal
      disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal
      residual disease (MRD)- based risk-adapted therapy.

      The Secondary Objectives of this study are:

        -  To estimate the event-free survival and overall survival of children with lymphoblastic
           lymphoma who are treated with MDD- or MRD-based risk- directed therapy.

        -  To evaluate the prognostic value of levels of MDD at diagnosis and MRD on day 8 of
           remission induction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of newly diagnosed lymphoblastic lymphoma (patients must have <25% tumor
             cells in bone marrow by morphology)

          2. Age ≤ 21 years

          3. Limited prior therapy, including systemic glucocorticoids for 1 week or less, 1 dose
             of vincristine, emergency radiation therapy to the mediastinum, and 1 dose of IT
             chemotherapy. Other circumstances must be cleared by PI or co-PI.

          4. Written, informed consent and assent following guidelines of the Institutional Review
             Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office
             of Human Research Protections (OHRP).

        Exclusion Criteria:

          1. Participants with prior therapy, other than therapy specified in 3 above.

          2. Participants who are pregnant or lactating.

          3. Inability or unwillingness of research participant or legal guardian/representative to
             give written informed consent.