Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT02393157
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
31 Years
Study:
NCT02393157
Study Brief:
Protocol Section:
NCT02393157