MedTrace Logo

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

NCT02393157 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-08

No results posted yet for this study

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
  • Follicular Lymphoma, Grade III

Interventions

DRUG

Obinutuzumab

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

DRUG

Liposomal ARA-C

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

DRUG

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.

DRUG

Carboplatin

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

DRUG

Etoposide

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

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    collaborator OTHER

  • New York Medical College

    lead OTHER

Principal Investigators

  • Mitchell Cairo, MD · New York Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-21
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02393157 on ClinicalTrials.gov