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Treatment for Advanced B-Cell Lymphoma (REBOOT)

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ClinicalTrials.gov Identifier: NCT01859819
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
New York Medical College

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
Diffuse Large Cell Lymphoma Burkitt's Lymphoma High Grade B-cell Lymphoma Drug: Rituximab Drug: IT Cytarabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


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 Name: RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385

Drug: IT Cytarabine
Other Name: 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 Name: RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385

Drug: IT Cytarabine
Other Name: DEPOCYT® (Cytarabine Liposome Injection)

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,
Drug: Rituximab
Other Name: RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385

Drug: IT Cytarabine
Other Name: DEPOCYT® (Cytarabine Liposome Injection)




Primary Outcome Measures :
  1. To determine if disease response rate will improve with this combination of therapy. [ Time Frame: 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. [ Time Frame: 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.



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Ages Eligible for Study:   3 Years to 31 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 3. 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.


Information from the National Library of Medicine

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): NCT01859819


Contacts
Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Stanton Goldman, MD 972 566-6647 ext x4435 stan.goldman@usoncology.com

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Matthew Barth, MD       Matthew.Barth@RoswellPark.org   
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, MSN       lauren_harrison@nymc.edu   
United States, North Carolina
Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Javier Oesterheld, MD       Javier.Oesterheld@carolinashealthcare.org   
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kimble Frazer, MD       kimble-frazer@ouhsc.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Michael Pulsipher, MD       michael.pulsipher@hsc.utah.edu   
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

Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT01859819     History of Changes
Other Study ID Numbers: NYMC-157
L 10,753 ( Other Identifier: New York Medical College )
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by New York Medical College:
Pediatric
Lymphoma (NOT primary mediastinal B-cell lymphoma)
B-Cell---Burkitt's like
Rituximab
Liposomal ARA-C

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Rituximab
Cytarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents