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

Diffuse Large B-Cell Lymphoma Clinical Trial

— O-ICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393157
• Other study ID #: L-11,392
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2015
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: New York Medical College
• Contact: Mitchell Cairo, MD
• Phone: 914-594-2150
• Email: Mitchell_Cairo[@]nymc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 31 Years

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• CD20+ Lymphoblastic Lymphoma
• Diffuse Large B-Cell Lymphoma
• Follicular Lymphoma, Grade III
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Primary Mediastinal B-cell Lymphoma

Intervention

Drug:
• Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
• Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
• 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.
• Carboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
• Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Medical College	Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by adverse reactions and events	Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.	1 month
Primary	Response rate assessed following each treatment cycle for regression of tumor	Patients will be assessed following each treatment cycle for regression of tumor.	3 months