RecruitingPhase 2NCT02393157

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

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


Sponsor

New York Medical College

Enrollment

25 participants

Start Date

Aug 21, 2015

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 3 YearsMax Age: 31 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a targeted antibody drug called obinutuzumab with a standard chemotherapy regimen in children and young adults whose aggressive B-cell lymphoma or leukemia has come back or did not respond to initial treatment. **You may be eligible if...** - You have a CD20-positive B-cell blood cancer (such as diffuse large B-cell lymphoma, Burkitt lymphoma, or follicular lymphoma grade III) that has returned or did not respond to first-line treatment - You have not received the drug obinutuzumab before - Your body is functioning reasonably well - Your organ function is adequate - At least 2 weeks have passed since your last chemotherapy **You may NOT be eligible if...** - You have a newly diagnosed B-cell cancer that has not been treated yet - You have a known immune deficiency (inherited or acquired) - You have had a previous organ transplant - You had a bone marrow transplant less than 60 days ago, or have active severe graft-versus-host disease - You have had a severe allergic reaction to a monoclonal antibody drug before - You have uncontrolled hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab

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

DRUGLiposomal ARA-C

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

DRUGIfosfamide

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

DRUGCarboplatin

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

DRUGEtoposide

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


Locations(1)

New York Medical College

Valhalla, New York, United States

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NCT02393157


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