Clinical trial NCT02393157: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Official title: Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Primary Mediastinal B-cell Lymphoma
CD20+ Lymphoblastic Lymphoma
Follicular Lymphoma, Grade III
Lead sponsor: New York Medical College
Sponsor class: OTHER
Collaborators: name: Roswell Park Cancer Institute
First posted: 2015-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 31
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Safety as assessed by adverse reactions and events
timeFrame: 1 month
measure: Response rate assessed following each treatment cycle for regression of tumor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Mitchell Cairo, MD
role: STUDY_CHAIR
affiliation: Roswell Park Cancer Institute
name: Matthew Barth, MD
role: PRINCIPAL_INVESTIGATOR
References: