NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 72
Summary
- Conditions
- Lymphoblastic Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 21 years
- Gender
- Both males and females
Description
TREATMENT PLAN Treatment will consist of 3 main phases: remission induction, consolidation [only for patients with any central nervous system (CNS) disease and/or testicular involvement], and continuation. Induction (6-7 weeks). Consolidation for participants with CNS involvement or those with testi...
TREATMENT PLAN Treatment will consist of 3 main phases: remission induction, consolidation [only for patients with any central nervous system (CNS) disease and/or testicular involvement], and continuation. Induction (6-7 weeks). Consolidation for participants with CNS involvement or those with testicular disease only (10 weeks). Reintensification - Participants with residual disease any time after induction therapy may receive 1-2 cycles of re-intensification therapy and may proceed to allogeneic stem cell transplant if suitable donor is available. Continuation Therapy (98-120 weeks). Intrathecal Chemotherapy (days 1 and 15; if needed also on days 8 and 22) TREATMENT SCHEME T lymphoblastic lymphoma: bone marrow/peripheral blood (BM/PB) involvement (MDD/MRD): Diagnosis: less than 1%; Day 8: +/- (Stratum 1) Induction Single dose of Cyclophosphamide Steroid: prednisone Continuation: 98 weeks T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: - (Stratum 2) Induction Fractionated Cyclophosphamide Steroid: prednisone Continuation : 98 weeks T lymphoblastic lymphoma: BM/PB involvement (MDD/MRD): Diagnosis: equal to or greater than 1%; Day 8: + (Stratum 3) Induction Fractionated Cyclophosphamide Steroid: prednisone and dexamethasone Continuation: 120 weeks B lymphoblastic lymphoma: Stage I-III (Stratum 1) Induction Single dose of Cyclophosphamide Steroid: prednisone Continuation: 98 weeks B lymphoblastic lymphoma: Stage IV or testicular (Stratum 2) Induction Fractionated Cyclophosphamide Steroid: prednisone Continuation: 98 weeks Patients with CNS or testicular involvement will receive Consolidation therapy prior to continuation therapy and receive extended maintenance therapy (120 weeks). Any patient with detectable disease (MRD, bone marrow or biopsy of residual mass) at the end of induction may be considered for reintensification and/or hematopoietic stem cell transplantation (HSCT).
Tracking Information
- NCT #
- NCT01451515
- Collaborators
- National University, Singapore
- Investigators
- Principal Investigator: Hiroto Inaba, MD,PhD St. Jude Children's Research Hospital
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