Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

Summary

This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

Conditions

• HIV Infection
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Plasmablastic Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Adult Non-Hodgkin Lymphoma
• Recurrent Burkitt Lymphoma
• Recurrent Follicular Lymphoma
• Stage III Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage IV Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

DRUG

Carmustine

300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens.

DRUG

Cytarabine

100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.

DRUG

Etoposide

VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

DRUG

Melphalan

140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• California Institute for Regenerative Medicine (CIRM)

  collaborator OTHER

• AIDS Malignancy Consortium

  lead NETWORK

Principal Investigators

• Mehrdad Abedi · AIDS Malignancy Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-23

Primary Completion

2021-05-13

Completion

2036-03-31

Countries

• United States

Study Locations