Reduced Burden of Oncologic Therapy in Advanced B-cell Lymphoma (REBOOT ABLY) in Children, Adolescents and Young Adults With CD20+ Mature B-Cell Lymphoma

NCT01859819 Phase 2 COMPLETED

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).

Details

Lead sponsor	New York Medical College
Phase	Phase 2
Status	COMPLETED
Enrolment	45
Start date	2013-01
Completion	2021-06

Conditions

• Diffuse Large Cell Lymphoma
• Burkitt's Lymphoma
• High Grade B-cell Lymphoma

Interventions

• Rituximab
• IT Cytarabine

Primary outcomes

• To determine if disease response rate will improve with this combination of therapy. — 1 year
  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).

Countries

United States