NCT02378922

Gene-Modified HIV-Protected Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma

Autologous Transplantation and Stem Cell-Based Gene Therapy With LVsh5/C46 (CAL-1), a Dual Anti-HIV Lentiviral Vector, for the Treatment of HIV-Associated Lymphoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies gene-modified, human immunodeficiency virus (HIV)-protected stem cell transplant in treating patients with HIV-associated lymphoma. Stem cells, or cells which help form blood, are collected from the patient and stored. They are treated in the laboratory to help protect the immune system from HIV. Chemotherapy is given before transplant to kill lymphoma cells and to make room for new stem cells to grow. Patients then receive the stem cells that were collected from them before chemotherapy and have been genetically modified to replace the stem cells killed by the chemotherapy.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and feasibility of infusing gene-modified, HIV-protected hematopoietic stem/progenitor cells (HSPC) after high-dose chemotherapy for treatment of acquired immune deficiency syndrome (AIDS)-related lymphoma. II. To observe the change in gene-modified cell levels before and after antiviral treatment interruption. SECONDARY OBJECTIVES: I. To evaluate the molecular and clonal composition of gene-modified cells after hematopoietic cell transplant (HCT). II. To describe time to disease progression, progression-free survival, treatment-related mortality, time to neutrophil and platelet recovery, and incidence of infections. TERTIARY OBJECTIVES: I. To evaluate the effect of procedure on HIV-specific immune reconstitution. II. To observe the effect of HIV infection on the presence of gene-marked cells as determined by deoxyribonucleic (DNA) polymerase chain reaction (PCR). OUTLINE: CONDITIONING: Patients undergo high-dose chemotherapy or chemoradiotherapy according to institutional guidelines. STEM CELL INFUSION: Patients undergo hematopoietic stem cell transplant with LVsh5/C46 (Cal-1) transduced autologous CD34+ hematopoietic stem/progenitor cells (HSPC) on day 0. Note: Patients continue to receive highly active antiretroviral therapy (HAART) throughout treatment, with a 7-day break for apheresis. Patients may be eligible for a structured treatment interruption of up to 12 weeks after autologous hematopoietic stem cell transplant with gene-modified cells. After completion of study treatment, patients are followed up periodically for 2 years, every 6 months for 3 years, and then annually for 15 years post-HCT.

Conditions

• AIDS-Related Hodgkin Lymphoma
• AIDS-Related Non-Hodgkin Lymphoma
• HIV Infection
• Recurrent Hodgkin Lymphoma
• Recurrent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Gene-Modified HIV-Protected Hematopoietic Stem Cells	Receive LVsh5/C46 (Cal-1) transduced CD34+ HSPC IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Transplant Conditioning	Undergo high-dose chemotherapy or chemoradiotherapy

Timeline

• Start date: 2016-06-22
• Primary completion: 2019-06-15
• Completion: 2019-06-15
• First posted: 2015-03-04
• Last updated: 2018-12-27

Locations

1 site across 1 country: United States