Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma

Summary

This phase II trial studies the side effects of cord blood-derived expanded allogeneic natural killer cells (umbilical cord blood natural killer \[NK\] cells), rituximab, high-dose chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. A stem cell transplant using stem cells from the patient or a donor may be able to replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells, rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.

Conditions

• Mantle Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Follicular Lymphoma
• Recurrent Indolent Adult Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Follicular Lymphoma
• Refractory Indolent Adult Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo stem cell transplant

DRUG

Carmustine

Given IV

BIOLOGICAL

Cord Blood-derived Expanded Allogeneic Natural Killer Cells

Given IV

DRUG

Cytarabine

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Lenalidomide

Given PO

DRUG

Melphalan

Given IV

BIOLOGICAL

Rituximab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Yago L Nieto · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-10

Primary Completion

2021-08-16

Completion

2021-08-16

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations