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NCT02393157 | RECRUITING | Non-Hodgkin Lymphoma

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Sponsor:

New York Medical College

Information provided by (Responsible Party):

Mitchell Cairo

Brief Summary:

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 or disease

Non-Hodgkin Lymphoma

Burkitt Lymphoma

Diffuse Large B-Cell Lymphoma

Primary Mediastinal B-cell Lymphoma

CD20+ Lymphoblastic Lymphoma

Follicular Lymphoma, Grade III

Intervention/treatment

Obinutuzumab

Liposomal ARA-C

Ifosfamide

Carboplatin

Etoposide

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
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
Actual Study Start Date : 2015-08-21
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2024-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 31 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

Location Details

NCT02393157

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Locations

RECRUITING

United States, New York

New York Medical College

Valhalla, New York, United States, 10595