NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
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|ClinicalTrials.gov Identifier: NCT01451515|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2011
Last Update Posted : December 10, 2018
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|
Show Detailed Description
|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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|