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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New York Medical College — Valhalla

Идентификаторы

NCT: NCT02393157 · L-11,392

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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