Using obinutuzumab with chemotherapy for relapsed CD20+ Non-Hodgkin Lymphoma in young patients
Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
This study is testing if a new drug called obinutuzumab, alone or with chemotherapy, can help young patients with relapsed CD20 positive Non-Hodgkin Lymphoma feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 3 Years to 31 Years |
| Sex | All |
| Sponsor | New York Medical College Academic / other |
| Drugs / interventions | obinutuzumab, chemotherapy, Radiation |
| Locations | 1 site (Valhalla, New York) |
| Trial ID | NCT02393157 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of obinutuzumab, both alone and in combination with ICE chemotherapy (ifosfamide, carboplatin, and etoposide), for children, adolescents, and young adults with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma. Participants will be assessed for their response to treatment and any associated side effects. The study focuses on patients who have experienced a first relapse or primary induction failure of specific types of B-cell leukemia/lymphoma. The goal is to improve treatment outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are children, adolescents, and young adults with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma who meet specific eligibility criteria.
Not a fit: Patients who have previously received obinutuzumab or those with significant prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for young patients with relapsed CD20 positive Non-Hodgkin Lymphoma.
How similar studies have performed: Other studies have shown promising results with similar approaches using obinutuzumab in combination with chemotherapy for B-cell lymphomas.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Valhalla, New York
- New York Medical College — Valhalla, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mitchell Cairo, MD
- Email: Mitchell_Cairo@nymc.edu
- Phone: 914-594-2150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.