Treatment for Advanced B-Cell Lymphoma

Part of paid clinical trials in Buffalo, New York.

Sponsor
New York Medical College
Study ID
NCT01859819
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Years - 31 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jan 31, 2013
Status verified
Oct 2022
Primary completion
Jun 30, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group B
    De-novo Mature CD 20 + B-NHL excluding PMBL histology. Good Risk FAB Group B includes patients with St. Jude Stages I /II (unresected) and stage III/IV with diagnostic LDH \<2 X ULN. REDUCTION: Cyclophosphamide, Vincristine, Prednisone, IT Methotrexate INDUCTION:Rituximab, Vincristine, Methotrexate, Leukovorin, Cyclophosphamide, Doxorubicin CONSOLIDATION: Rituximab, Methotrexate, Leukovorin, Cytarabine
  • Experimental: Group C, CNS negative
    De-novo Mature CD 20 + B-ALL (\> 25% Bone marrow blasts) without CNS involvement. REDUCTION: Cyclophosphamide, Vincristine, Prednisone, IT Methotrexate, IT Cytarabine INDUCTION: Rituximab, Vincristine, Methotrexate, Leukovorin, Cyclophosphamide, Doxorubicin, IT Methotrexate, IT Cytarabine CONSOLIDATION: Rituximab, Cytarabine, Etoposide MAINTENANCE: Vincristine, Prednisone, Methotrexate, Leukovorin, Cyclophosphamide, Doxorubicin, Etoposide, Cytarabine
  • Experimental: Group C, CNS Positive
    De-novo Mature CD 20 + B-NHL with CNS involvement: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal REDUCTION: Cyclophosphamide, Vincristine, Prednisone, IT Methotrexate, IT Cytarabine INDUCTION: Rituximab, Methotrexate, Leukovorin, Cyclophosphamide, Doxorubicin, IT Methotrexate, IT Cytarabine, IT Liposomal ARA-C, Vincristine CONSOLIDATION: Rituximab, Cytarabine, Etoposide MAINTENANCE: Vincristine, Cyclophosphamide, Methotrexate, Leukovorin, Doxorubicin, IT Liposomal ARA-C,

Primary Outcome Measure

To determine if disease response rate will improve with this combination of therapy. [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-
New York Medical CollegeValhallaNew York10595-
Levine Children's HospitalCharlotteNorth Carolina28204-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of UtahSalt Lake CityUtah84112-

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NYNew York Medical College· Valhalla, NYLevine Children's Hospital· Charlotte, NCUniversity of Oklahoma Health Sciences Center· Oklahoma City, OKUniversity of Utah· Salt Lake City, UT

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