DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 events

Response 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017