New York Medical College
Valhalla, New York, 10595, United States
Location status: Recruiting
Location contact
Jessica Hochberg, MD
CONTACT
Mitchell Cairo, MD
CONTACT
NCT Number: NCT02393157
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).
Interested in participating?
Request Info3 year–31 year
All sexes
Interventional
Phase 2
Valhalla, New York, 10595, United States
Location status: Recruiting
Jessica Hochberg, MD
CONTACT
Mitchell Cairo, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Other names: Gazyva
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Other names: Depocyte
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: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Other names: Paraplatin
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Other names: VP-16
Time frame: 1 month
Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.
Time frame: 3 months
Patients will be assessed following each treatment cycle for regression of tumor.
Contact information is provided by the study sponsor or research team.
Jessica Hochberg, MD
CONTACT
Mitchell Cairo, MD
CONTACT
New York Medical College
Other
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
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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