To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, \[Depocyt®\]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Medical College
Valhalla, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
To determine if disease response rate will improve with this combination of therapy.
To determine if the addition of intrathecal (\[IT\] \[Depocyt®\]) and reduction of standard IT dosing and the reduction of anthracycline exposure (doxorubicin) (60%) within the ANHL01P1 FAB/LMB B4 + Rituximab chemoimmunotherapy backbone in children, adolescents and young adults with good risk CD20+ mature B-NHL (Stage I and II unresected and Stage III/IV with LDH \< 2 UNL) will result in similar response rates compared to historical controls (Subgroup I).
Time frame: 1 year
To determine if the combination of IT Depocyte®, Rituximab and FAB Chemotherapy is safe.
To determine the safety and efficacy of reduction of IT therapy and substitution with L-ARA-C (Depocyte®) within ANHL01P1 FAB/LMB Group C1 plus rituximab chemotherapy backbone in children, adolescents and young adults with advanced risk de-novo mature B-NHL (Group C BM±CNS) (Subgroup II) as measured by reported serious adverse events.
Time frame: 1 year
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University of Utah
Salt Lake City, Utah, United States