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Recruiting

NCT Number: NCT02393157

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature 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).

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obinutuzumab

Drug

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

Other names: Gazyva

Liposomal ARA-C

Drug

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

Other names: Depocyte

ifosfamide

Drug

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

Other names: Ifex

carboplatin

Drug

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

Other names: Paraplatin

etoposide

Drug

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

Other names: VP-16

Primary outcomes

  1. Safety as assessed by adverse reactions and events

    Time frame: 1 month

    Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.

  2. Response rate assessed following each treatment cycle for regression of tumor

    Time frame: 3 months

    Patients will be assessed following each treatment cycle for regression of tumor.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Hochberg, MD

CONTACT

[email protected]

914-594-2150

Mitchell Cairo, MD

CONTACT

[email protected]

914-594-2150

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Collaborators

  • Roswell Park Cancer Institute

Registry information

Official study title

Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL

Acronym: O-ICE

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2015
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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