Burkitt Lymphoma, CD20+ Lymphoblastic Lymphoma, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Grade III, Non-Hodgkin Lymphoma, Primary Mediastinal B-cell Lymphoma
Conditions
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).
Interventions
DRUGObinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
DRUGLiposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
DRUGIfosfamide
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
DRUGCarboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
DRUGEtoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Sponsors
Roswell Park Cancer Institute
New York Medical College
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 31 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by adverse reactions and events | 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 | 3 months | Patients will be assessed following each treatment cycle for regression of tumor. |
Countries
United States
Contacts
Primary ContactMitchell Cairo, MD
Backup ContactJessica Hochberg, MD
Outcome results
None listed