Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies
In this study the investigators investigate a cell therapy strategy that could harness allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators have designed a novel lymphodepleting conditioning regimen followed by infusion of donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory lymphoid malignancies.
B Cell Non-Hodgkin Lymphoma
High Risk Chronic Lymphocytic Leukemia
Biological: Natural killer cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15)|
- Objective Response Rate [ Time Frame: Month 2 Post Infusion ] [ Designated as safety issue: No ]The proportion of patients with an objective response rate (Partial Response +Complete Response) at 2 months post haploidentical NK cell infusion in patient with refractory/relapsed NHL or chronic lymphocytic leukemia (CLL).
- Serious Adverse Events [ Time Frame: Day 1 through Month 12 ] [ Designated as safety issue: Yes ]Number of serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections.
- Time to Disease Progression [ Time Frame: Day 1 through Month 12 ] [ Designated as safety issue: No ]Cumulative incidence will be used to determine time to disease progression.
- Patients with Expansion of NK Cells [ Time Frame: Day 14 ] [ Designated as safety issue: No ]Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Patients Receiving NK Cell Infusion
Non-Myeloablative Conditioning Using Pentostatin, Rituximab, Denileukin Diftitox (Ontak), Cyclophosphamide and Allogeneic Natural Killer Cells for Patients with Refractory Lymphoid Malignancies
375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
Other Names:Biological: Interleukin-2
subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
Other Name: IL-2Biological: Natural killer cells
administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
Other Name: NK cellsDrug: Cyclophosphamide
60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine.
Other Name: CytoxanDrug: Methylprednisolone
1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion.Drug: Fludarabine
25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day 6 through day -2).
|Contact: Judith Witte, RNemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Veronika Bachanova, MD 612-625-5469 firstname.lastname@example.org|
|Contact: Judith Witte, RN 612-626-0169 email@example.com|
|Principal Investigator: Veronika Bachanova, MD|
|Principal Investigator:||Veronika Bachanova, MD||Masonic Cancer Center, University of Minnesota|