NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: National University, Singapore
• Treatments: 6-Mercaptopurine; Antimetabolites; Asparaginase; BB 1101; Clofarabine; Cortisol succinate; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Prednisolone; Prednisone; Thioguanine; Vincristine

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.