REBOOT: Treatment for Advanced B-Cell Lymphoma

Sponsor
New York Medical College (Other)
Overall Status
Completed
CT.gov ID
NCT01859819
Collaborator
(none)
45
5
3
101
9
0.1

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reduced Burden of Oncologic Therapy in Advanced B-cell Lymphoma (REBOOT ABLY) in Children, Adolescents and Young Adults With CD20+ Mature B-Cell Lymphoma
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Rituximab
Other Names:
  • RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385
  • Drug: IT Cytarabine
    Other Names:
  • DEPOCYT® (Cytarabine Liposome Injection)
  • 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

    Drug: Rituximab
    Other Names:
  • RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385
  • Drug: IT Cytarabine
    Other Names:
  • DEPOCYT® (Cytarabine Liposome Injection)
  • Experimental: Group C, CNS Positive

    De-novo Mature CD 20 + B-NHL with CNS involvement: Any L3 blasts in CSF Cranial nerve palsy (if not explained by extracranial tumor) Clinical spinal cord compression Isolated intracerebral mass 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,

    Drug: Rituximab
    Other Names:
  • RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385
  • Drug: IT Cytarabine
    Other Names:
  • DEPOCYT® (Cytarabine Liposome Injection)
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    Secondary Outcome Measures

    1. To determine if the combination of IT Depocyte®, Rituximab and FAB Chemotherapy is safe. [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 31 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma

      1. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2. Burkitt's Lymphoma
      1. High Grade B-cell Lymphoma---Burkitt's like.

    B-Cell Anaplastic Large cell Ki 1 positive lymphomas, Primary Mediastinal B-Cell Lymphoma (PMBL), and B-Lymphoblastic lymphomas are ineligible.

    No previous chemotherapy. Patients who have received emergency irradiation and/or steroid therapy will be eligible ONLY if started on protocol therapy not more than 72 hours from the start of radiotherapy or steroids. Bone marrow and cerebrospinal fluid MUST be obtained before steroids are given for patient to be eligible for the study.

    Exclusion Criteria:
    • Patients with newly diagnosed Group A (low risk) lymphoma. Patients with Group B (intermediate risk) if classified as Murphy Stage III/IV and diagnostic LDH > 2 XULN and patients with primary mediastinal B-cell lymphoma (PMBL).

    • Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol.

    • No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy.

    • No prior solid organ transplantation.

    • Patients with previous malignancies that have been treated with systemic chemotherapy with alkylator or anthracycline therapy. The latter group of patients are excluded due to an expected increase in late effects (eg. late cardiac toxicity, secondary malignancies, sterility, etc.).

    • Patients with known G6PD deficiency are NOT ELIGIBLE for Rasburicase therapy. Patients with G6PD deficiency should be treated with alkalinization, IV hydration and po and/or IV allopurinol during the reduction phase (COP).

    4.2.6 Patients with serious (sepsis, pneumonia, etc..) proven or suspected infections at diagnosis will be excluded.

    4.2.7 Pregnancy or Breast-Feeding: No information is available regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263
    2 New York Medical College Valhalla New York United States 10595
    3 Levine Children's Hospital Charlotte North Carolina United States 28204
    4 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    5 University of Utah Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • New York Medical College

    Investigators

    • Principal Investigator: Mitchell S Cairo, MD, New York Medical College
    • Study Director: Stanton Goldman, MD, Medical City Children's Hospital, Dallas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    New York Medical College
    ClinicalTrials.gov Identifier:
    NCT01859819
    Other Study ID Numbers:
    • NYMC-157
    • L 10,753
    First Posted:
    May 22, 2013
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Nov 3, 2021