Actively Recruiting

Phase 2
Age: 3Years - 31Years
All Genders
NCT02393157

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

Led by New York Medical College · Updated on 2025-08-08

25

Participants Needed

1

Research Sites

640 weeks

Total Duration

On this page

Sponsors

N

New York Medical College

Lead Sponsor

R

Roswell Park Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

Who Can Participate

Age: 3Years - 31Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in first relapse or primary induction failure with CD20 positive B-cell leukemia/lymphoma including Diffuse Large B-Cell Lymphoma, Burkitt Lymphoma, High Grade B-cell Lymphoma Not Otherwise Specified, Primary Mediastinal B-cell Lymphoma, CD20+ B-lymphoblastic lymphoma, and Follicular lymphoma Grade III
  • Karnofsky score 60% for patients older than 16 years
  • Lansky score 60 for patients 16 years or younger
  • No myelosuppressive chemotherapy received within 2 weeks prior to study entry
  • No prior therapy with obinutuzumab (GA101)
  • Radiation therapy dates: more than 2 weeks since local palliative XRT, more than 6 months since craniospinal or >50% pelvic radiation, more than 6 weeks since other substantial bone marrow radiation
  • Prior steroid treatment allowed if started no more than 7 days before protocol therapy
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • 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 grade 3 or higher
  • History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies
  • Uncontrolled hepatitis B and/or C infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

New York Medical College

Valhalla, New York, United States, 10595

Actively Recruiting

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Research Team

M

Mitchell Cairo, MD

CONTACT

J

Jessica Hochberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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