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

Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:3 - 31
Start Date:February 2015
End Date:December 2020
Contact:Mitchell Cairo, MD

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Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL

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).

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
We found this trial at
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
Valhalla, NY
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