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

Primary Purpose

Non-Hodgkin Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obinutuzumab
Liposomal ARA-C
Ifosfamide
Carboplatin
Etoposide
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

3 Years - 31 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Central Nervous System (CNS) Negative

CNS Positive

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Response rate assessed following each treatment cycle for regression of tumor
Patients will be assessed following each treatment cycle for regression of tumor.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2015
Last Updated
September 27, 2022
Sponsor
New York Medical College
Collaborators
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02393157
Brief Title
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Medical College
Collaborators
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Primary Mediastinal B-cell Lymphoma, CD20+ Lymphoblastic Lymphoma, Follicular Lymphoma, Grade III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Central Nervous System (CNS) Negative
Arm Type
Experimental
Arm Description
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.
Arm Title
CNS Positive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Liposomal ARA-C
Other Intervention Name(s)
Depocyte
Intervention Description
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Ifex
Intervention Description
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Primary Outcome Measure Information:
Title
Safety as assessed by adverse reactions and events
Description
Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.
Time Frame
1 month
Title
Response rate assessed following each treatment cycle for regression of tumor
Description
Patients will be assessed following each treatment cycle for regression of tumor.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell Cairo, MD
Phone
914-594-2150
Email
Mitchell_Cairo@nymc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Hochberg, MD
Phone
914-594-2150
Email
jessica_hochberg@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Cairo, MD
Organizational Affiliation
New York Medical College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthew Barth, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Hochberg, MD
Phone
914-594-2150
Email
jessica_hochberg@nymc.edu
First Name & Middle Initial & Last Name & Degree
Mitchell Cairo, MD
Phone
914-594-2150
Email
mitchell_cairo@nymc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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