NCT01451515

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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).

Conditions

• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Prednisone	Given orally (PO).
DRUG	Vincristine	Given intravenously (IV).
DRUG	Daunorubicin	Given IV.
DRUG	PEG-asparaginase	Given intramuscularly (IM) or IV.
DRUG	Erwinia asparaginase	Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
DRUG	Doxorubicin	Given IV.
DRUG	Cyclophosphamide	Given IV.
DRUG	Cytarabine	Given IV or IT.
DRUG	Thioguanine	Given PO.
DRUG	Clofarabine	Given IV.
DRUG	Methotrexate	Given IV, IM or IT.
DRUG	Mercaptopurine	Given PO.
DRUG	Dexamethasone	Given PO or IV.
DRUG	Hydrocortisone	Given IT.
DRUG	Etoposide	Given IV.

Timeline

• Start date: 2012-05-25
• Primary completion: 2021-05-08
• Completion: 2022-05-31
• First posted: 2011-10-13
• Last updated: 2022-06-28
• Results posted: 2022-05-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study