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Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (O-ICE)

This study is currently recruiting participants.
Verified October 2016 by Mitchell Cairo, New York Medical College
Sponsor:
ClinicalTrials.gov Identifier:
NCT02393157
First Posted: March 19, 2015
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College
  Purpose
The purpose of this study is to determine the safety of administering obinutuzumab as a single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and determine the response rate of this treatment for children, adolescents and young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).

Condition Intervention Phase
Non-Hodgkin Lymphoma Burkitt Lymphoma Diffuse Large B-Cell Lymphoma Primary Mediastinal B-cell Lymphoma CD20+ Lymphoblastic Lymphoma Follicular Lymphoma, Grade III Drug: Obinutuzumab Drug: Liposomal ARA-C Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL

Resource links provided by NLM:


Further study details as provided by Mitchell Cairo, New York Medical College:

Primary Outcome Measures:
  • Safety as assessed by adverse reactions and events [ Time Frame: 1 month ]
    Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.

  • Response rate assessed following each treatment cycle for regression of tumor [ Time Frame: 3 months ]
    Patients will be assessed following each treatment cycle for regression of tumor.


Estimated Enrollment: 25
Study Start Date: February 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Central Nervous System (CNS) Negative
All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.
Drug: Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Other Name: Gazyva
Drug: Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Other Name: Depocyte
Drug: Ifosfamide
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
Other Name: Ifex
Drug: Carboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Other Name: Paraplatin
Drug: Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Other Name: VP-16
Experimental: CNS Positive
All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.
Drug: Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Other Name: Gazyva
Drug: Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Other Name: Depocyte
Drug: Ifosfamide
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
Other Name: Ifex
Drug: Carboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Other Name: Paraplatin
Drug: Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Other Name: VP-16

  Eligibility

Information from the National Library of Medicine

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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:

  • Patients in first relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma including:

    • Diffuse Large B-Cell Lymphoma
    • Burkitt Lymphoma
    • High Grade B-cell Lymphoma: Not Otherwise Specified (NOS)
    • Primary mediastinal B-cell lymphoma (PMBL)
    • CD20+ B-lymphoblastic lymphoma
    • Follicular lymphoma, Grade III
    • Karnofsky ≥ 60% for patients > 16 years of age and
    • Lansky ≥ 60 for patients ≤ 16 years of age.
    • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study.
    • Patients may not have received prior therapy with obinutuzumab (GA101)
    • Radiation Therapy (XRT): Date of receiving prior XRT must be > 2 weeks for local palliative XRT (small port); > 6 months must have elapsed if prior craniospinal XRT or if > 50% radiation of pelvis; > 6 weeks must have elapsed if other substantial bone marrow radiation.
    • Steroids: Patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy.
    • Adequate organ function.

Exclusion Criteria:

  • Patients with newly diagnosed, previously untreated B-NHL.
  • Known congenital or acquired immune deficiency.
  • Prior solid organ transplantation.
  • Prior allogeneic stem cell transplant within 60 days or active acute Graft-vs-Host-Disease (GVHD) grade 3 or higher.
  • History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies
  • Uncontrolled hepatitis B and/or C infection
  Contacts and Locations
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): NCT02393157


Contacts
Contact: Mitchell Cairo, MD 914-594-2150 Mitchell_Cairo@nymc.edu
Contact: Jessica Hochberg, MD 914-594-2150 jessica_hochberg@nymc.edu

Locations
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica Hochberg, MD    914-594-2150    jessica_hochberg@nymc.edu   
Contact: Mitchell Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Sponsors and Collaborators
New York Medical College
Roswell Park Cancer Institute
Investigators
Study Chair: Mitchell Cairo, MD New York Medical College
Principal Investigator: Matthew Barth, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Mitchell Cairo, Vice Chair, New York Medical College
ClinicalTrials.gov Identifier: NCT02393157     History of Changes
Other Study ID Numbers: L-11,392
First Submitted: March 8, 2015
First Posted: March 19, 2015
Last Update Posted: October 5, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Burkitt Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Etoposide phosphate
Isophosphamide mustard
Obinutuzumab
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors