Recruiting
Phase 2

Obinutuzumab & ICE

Sponsor:

New York Medical College

Code:

NCT02393157

Conditions

Non-Hodgkin Lymphoma

Burkitt Lymphoma

Diffuse Large B-Cell Lymphoma

Primary Mediastinal B-cell Lymphoma

CD20+ Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 3 - 31

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Liposomal ARA-C

Ifosfamide

Carboplatin

Etoposide

Study Details

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).

Conditions

Non-Hodgkin Lymphoma

Burkitt Lymphoma

Diffuse Large B-Cell Lymphoma

Primary Mediastinal B-cell Lymphoma

CD20+ Lymphoblastic Lymphoma

Study ID

NCT02393157

Start date

Aug 21, 2015

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 31

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Central Nervous System (CNS) Negative

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.

experimental: CNS Positive

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.

Interventions

Obinutuzumab

Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.

Liposomal ARA-C

Will be given intrathecally for both prophylaxis and treatment of CNS disease.

Ifosfamide

Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.

Carboplatin

Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.

Etoposide

Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).

Primary outcome measure

  • Safety as assessed by adverse reactions and events [ Time Frame: 1 month ]
  • Response rate assessed following each treatment cycle for regression of tumor [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Mitchell Cairo, MD

914-594-2150Mitchell_Cairo@nymc.edu

Jessica Hochberg, MD

914-594-2150jessica_hochberg@nymc.edu

Locations

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Jessica Hochberg, MD

914-594-2150jessica_hochberg@nymc.edu

Mitchell Cairo, MD

914-594-2150mitchell_cairo@nymc.edu

More Information

Sponsor

New York Medical College

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York Medical College on 2025-08-08.