Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT03019640|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : April 27, 2018
The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy and a stem cell transplant to patients with non-Hodgkin's lymphoma. Participants will receive an autologous stem cell transplant (a transplant of your own bone marrow or blood cells).
Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers believe that the NK cells you receive from the donor may react against the non-Hodgkin's lymphoma cells in your body, which may help to control the disease.
The NK cells will be separated from a donor's umbilical cord blood. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to you by vein. If certain types of unwanted T cells are growing too much, an investigational device called a CliniMACS system will be used to filter out the unwanted T cells using a magnet.
This is an investigational study. The way researchers process the NK cells is investigational. It is currently being used for research purposes only.
The study drugs (carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab) are FDA approved and commercial available. Their use to prepare your body before an NK cell infusion is investigational.
The study doctor can explain how the study therapy is designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Non-Hodgkin Lymphoma||Biological: NK Cells Drug: Rituximab Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Drug: Lenalidomide Drug: G-CSF Biological: Auto SCT Other: Apheresis||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
Experimental: CB-Derived NK Cells with HDC/Auto SCT
High dose chemotherapy (HDC) [Rituximab +BEAM + Lenalidomide] as preparative regimen + umbilical cord blood derived NK cells + autologous stem cell transplant (autosct) for treatment of lymphoma that requires a stem cell transplant (SCT)
Biological: NK Cells
On D-5, the New Killer (NK) cell infusion administered by vein.Drug: Rituximab
On D-13 and D-7, administered at dose of 375 mg/m2 by vein.
Other Name: RituxanDrug: Carmustine
On D-12, administered at a dose of 300 mg/m2 by vein over 2 hours.
Other Names:Drug: Etoposide
On D-11 to D-8, administered at a dose of 200 mg/m2 by vein twice a day over 3 hours.
Other Name: VePesidDrug: Cytarabine
On D-11 to D-8, administered at a dose of 200 mg/m2 by vein twice a day over 1 hour.
Other Names:Drug: Melphalan
On D-7, administered at a dose of 140 mg/m2 by vein over 30 minutes.
Other Name: AlkeranDrug: Lenalidomide
On D-7 to D-2, administered at a dose of 10 mg orally (PO).
Other Names:Drug: G-CSF
Dose of 5 mcg/kg/day (round up to the nearest vial) subcutaneously beginning on D+5, and continuing until evidence of an absolute neutrophil count (ANC) of 0.5 x 10^9/L per 3 consecutive days
Other Names:Biological: Auto SCT
On D0, autologous stem cell (Auto SCT) infusion minimum cell dose of 2e6 cells/kg.Other: Apheresis
Apheresis of up to 1 x 10^8 CD34+ cells/kg will be completed prior to beginning NK cell production. Process will start no less than 14 days (D-19) prior to infusion on D-5.
- Treatment-related mortality (TRM) within 30 days [ Time Frame: 30 days ]Number of participants with transplant related mortality within 30 days.
- Relapse-free survival (RFS) [ Time Frame: 1 year ]RFS will be defined as the time from transplant to either progression/relapse or death, whichever occurs first, or last contact
- Overall survival (OS) [ Time Frame: 2 years ]OS will be defined as the time from transplant to death or last contact.
- NK Cell Persistence: Duration of infused Allo UCB-derived NK cells [ Time Frame: 14 weeks ]NK cell persistence: In order to quantify duration of infused allogeneic umbilical cord blood (UCB)-derived natural killer (NK) cells in the recipient, NK cells measured weekly for 14 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019640
|Contact: Yago Nieto, MD||713-792-8750||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Study Chair:||Yago Nieto, MD||The University of Texas MD Anderson Cancer Center|