Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (O-ICE)

October 24, 2023 updated by: Mitchell Cairo, New York Medical College

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 31 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central Nervous System (CNS) Negative
All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.
Drug: Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Other Names:
  • Gazyva
Drug: Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Other Names:
  • Depocyte
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.
Other Names:
  • Ifex
Drug: Carboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Other Names:
  • Paraplatin
Drug: Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Other Names:
  • VP-16
Experimental: CNS Positive
All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.
Drug: Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Other Names:
  • Gazyva
Drug: Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Other Names:
  • Depocyte
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.
Other Names:
  • Ifex
Drug: Carboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Other Names:
  • Paraplatin
Drug: Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Other Names:
  • VP-16

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Medical College

Collaborators

Roswell Park Cancer Institute

Investigators

  • Study Chair: Mitchell Cairo, MD, New York Medical College
  • Principal Investigator: Matthew Barth, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 8, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimated)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-11,392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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