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New treatment option for Non-Hodgkin Lymphoma
Official title Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
ClinicalTrials.gov ID: NCT02393157
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, being studied as a potential treatment for non-hodgkin lymphoma.
Also referred to as Gazyva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 31
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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...
- Steroids: Patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy.
- Adequate organ function.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 31 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.