Non-Hodgkin LymphomaPhase 2O-ICENCT02393157
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
A Phase 2 study testing Obinutuzumab, Liposomal ARA-C and Ifosfamide in people with Non-Hodgkin Lymphoma and Burkitt Lymphoma, run by New York Medical College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 31 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma
- What is being tested?
- Obinutuzumab, Liposomal ARA-C and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2015to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 31 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Medical College
Valhalla, New York, 10595
Jessica Hochberg, MD, 914-594-2150, jessica_hochberg@nymc.edu
Mitchell Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu
About this study
Official title: Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
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).
- Conditions
- Non-Hodgkin Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Primary Mediastinal B-cell Lymphoma, CD20+ Lymphoblastic Lymphoma, Follicular Lymphoma, Grade III
- Being tested
- Obinutuzumab, Liposomal ARA-C, Ifosfamide, Carboplatin, Etoposide
- Medical subject headings
- Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called Gazyva
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Liposomal ARA-CDrug
Also called Depocyte
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
IfosfamideDrug
Also called Ifex
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
CarboplatinDrug
Also called Paraplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
EtoposideDrug
Also called VP-16
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
| Study group | Role | What they receive |
|---|---|---|
| Central Nervous System (CNS) Negative | Experimental | All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1. Receives: Drug: Obinutuzumab; Drug: Liposomal ARA-C; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
| CNS Positive | Experimental | All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1. Receives: Drug: Obinutuzumab; Drug: Liposomal ARA-C; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse reactions and events
Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.
Measured: 1 month
Response rate assessed following each treatment cycle for regression of tumor
Patients will be assessed following each treatment cycle for regression of tumor.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start21 Aug 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Roswell Park Cancer Institute
- Responsible party
- Principal investigator, Mitchell Cairo, New York Medical College
- Investigators
- Mitchell Cairo, MD, Study chair, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393157
- Sponsor's protocol ID
- L-11,392
- Acronym
- O-ICE
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2015
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes