NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
|ClinicalTrials.gov Identifier: NCT01451515|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2011
Last Update Posted : December 3, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Lymphoblastic Lymphoma||Drug: Prednisone Drug: Vincristine Drug: Daunorubicin Drug: PEG-asparaginase Drug: Erwinia asparaginase Drug: Doxorubicin Drug: Cyclophosphamide Drug: Cytarabine Drug: Thioguanine Drug: Clofarabine Drug: Methotrexate Drug: Mercaptopurine Drug: Dexamethasone Drug: Hydrocortisone Drug: Etoposide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma|
|Actual Study Start Date :||May 25, 2012|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Patients will undergo treatment as described in the intervention section. Interventions include:
Given orally (PO).
Other Name: Prednisolone
Given intravenously (IV).
Given intramuscularly (IM) or IV.
Drug: Erwinia asparaginase
Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
Other Name: Erwinase®
Other Name: Adriamycin®
Other Name: Cytoxan®
Given IV or IT.
Other Name: Purine antimetabolite
Given IV, IM or IT.
Given PO or IV.
Other Name: Decadron®
Other Name: Cortef®
- Event-free survival (EFS). [ Time Frame: Two years post therapy. ]Kaplan-Meier survival curve estimate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451515
|United States, California|
|Rady Children's Hospital San Diego|
|San Diego, California, United States, 92123|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Hiroto Inaba, MD,PhD||St. Jude Children's Research Hospital|