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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

This study is currently recruiting participants.
Verified November 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03019640
First Posted: January 12, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Treatment-related mortality (TRM) within 30 days [ Time Frame: 30 days ]
    Number of participants with transplant related mortality within 30 days.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Actual Study Start Date: October 10, 2017
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Rituxan
Drug: Carmustine
On D-12, administered at a dose of 300 mg/m2 by vein over 2 hours.
Other Names:
  • BCNU
  • BiCNU
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: VePesid
Drug: 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:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
Drug: Melphalan
On D-7, administered at a dose of 140 mg/m2 by vein over 30 minutes.
Other Name: Alkeran
Drug: Lenalidomide
On D-7 to D-2, administered at a dose of 10 mg orally (PO).
Other Names:
  • CC-5013
  • Revlimid
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:
  • Filgrastim
  • Neupogen
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 15-70
  2. Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation: 2. 1. Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment. 2.2. Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment. 2.3. Chemosensitive mantle-cell lymphoma in first or later line of treatment.
  3. Adequate renal function, as defined by estimated serum creatinine clearance >/= 60 ml/min and a normal serum creatinine for age.
  4. Adequate hepatic function (SGOT and/or SGPT </= 3 x ULN; total bilirubin and ALP </= 2 x ULN or </= 3 x ULN for Gilbert's disease.
  5. Adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) >/= 50% of the predicted value.
  6. Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  7. Performance status <2 (ECOG).
  8. Negative Beta HCG in woman with child-bearing potential.

Exclusion Criteria:

  1. Primary CNS lymphoma.
  2. Grade >/= 3 non-hematologic toxicity from prior therapy that has not resolved to </= G1.
  3. Prior whole brain irradiation.
  4. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/= 10,000 copies/mL, or >/= 2,000 IU/mL).
  5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
  6. Active infection requiring parenteral antibiotics.
  7. HIV infection.
  8. Radiation therapy in the month prior to enroll.
  9. Breastfeeding females.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019640


Contacts
Contact: Yago Nieto, MD 713-792-8750 CR_Study_Registration@mdanderson.org

Locations
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   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Yago Nieto, MD The University of Texas MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03019640     History of Changes
Other Study ID Numbers: 2015-0751
First Submitted: January 11, 2017
First Posted: January 12, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
B-Cell Non-Hodgkin Lymphoma
Relapsed follicular lymphoma
Indolent B-cell histology
Natural killer cells
NK
Stem cell transplant
Rituximab
Rituxan
Carmustine
BCNU
BiCNU
Etoposide
VePesid
Cytarabine
Ara-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride
Melphalan
Alkeran
Lenalidomide
CC-5013
Revlimid
G-CSF
Filgrastim
Neupogen

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Etoposide phosphate
Rituximab
Etoposide
Cytarabine
Melphalan
Carmustine
Lenograstim
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action