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

Official title

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

Overview

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).

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).

Primary outcome measures

• Safety as assessed by adverse reactions and events [Time frame: 1 month]
• Response rate assessed following each treatment cycle for regression of tumor [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• New York Medical College — Valhalla

Identifiers

NCT: NCT02393157 · L-11,392

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗