Clinical Trial: NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Brief 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 determine event-free and overall survival
- Investigate the relationship between Day 8 MRD and MDD results and EFS
Detailed Summary:
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
-
Sponsor: St. Jude Children's Research Hospital
- Overall survival (OS). [ Time Frame: Two years post therapy. ]Kaplan-Meier survival curve estimate.
- Percentage of lymphoblastic cells in bone marrow at diagnosis (MDD) and at day 8 of therapy (MRD). [ Time Frame: Two years post day 8. ]Cox regression modeling of EFS with MRD and MDD as explanatory variables.
- Overall survival (OS). [ Time Frame: Two years post therapy. ]Kaplan-Meier survival curve estimate.
- Percentage of lymphoblastic cells in bone marrow at diagnosis (MDD) and at day 28 of therapy (MRD). [ Time Frame: Two years post therapy. ]Cox regression modeling of EFS with MRD and MDD as explanatory variables.
Current Primary Outcome: Event-free survival (EFS). [ Time Frame: Two years post therapy. ]
Kaplan-Meier survival curve estimate.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: August 17, 2011
Date Started: May 25, 2012
Date Completion: June 30, 2021
Last Updated: April 11, 2017
Last Verified: April 2017
- Overall survival (OS). [ Time Frame: Two years post therapy. ]