Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Information source: New York Medical College
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin Lymphoma; Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma; Primary Mediastinal B-cell Lymphoma; CD20+ Lymphoblastic Lymphoma; Follicular Lymphoma, Grade III
Intervention: Obinutuzumab (Drug); Liposomal ARA-C (Drug); Ifosfamide (Drug); Carboplatin (Drug); Etoposide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: New York Medical College Official(s) and/or principal investigator(s): Mitchell Cairo, MD, Study Chair, Affiliation: New York Medical College Nader El-Mallawany, MD, Principal Investigator, Affiliation: New York Medical College
Overall contact: Mitchell Cairo, MD, Phone: 914-594-2150, Email: Mitchell_Cairo@nymc.edu
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).
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety as assessed by adverse reactions and eventsResponse rate assessed following each treatment cycle for regression of tumor
Eligibility
Minimum age: 3 Years.
Maximum age: 31 Years.
Gender(s): Both.
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
Locations and Contacts
Mitchell Cairo, MD, Phone: 914-594-2150, Email: Mitchell_Cairo@nymc.edu
New York Medical College, Valhalla, New York 10595, United States; Recruiting Nader El-Mallawany, MD, Phone: 914-594-2131, Email: nader_kim@nymc.edu Mitchell Cairo, MD, Phone: 914-594-2150, Email: mitchell_cairo@nymc.edu
Additional Information
Starting date: February 2015
Last updated: March 18, 2015
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