NCT02393157 Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
| NCT ID | NCT02393157 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York Medical College |
| Condition | Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2015-08-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2015-08-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Mitchell Cairo, MD
STUDY CHAIR
New York Medical College
Frequently Asked Questions
Who can join the NCT02393157 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 31 Years, studying Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02393157 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02393157 currently recruiting?
Yes, NCT02393157 is actively recruiting participants. Contact the research team at Mitchell_Cairo@nymc.edu for enrollment information.
Where is the NCT02393157 trial being conducted?
This trial is being conducted at Valhalla, United States.
Who is sponsoring the NCT02393157 clinical trial?
NCT02393157 is sponsored by New York Medical College. The principal investigator is Mitchell Cairo, MD at New York Medical College. The trial plans to enroll 25 participants.