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

Withdrawn before enrolling · Phase 1

Conditions studied: AIDS-Related Hodgkin Lymphoma, AIDS-Related Non-Hodgkin Lymphoma, HIV Infection, Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT02378922
Run by: Fred Hutchinson Cancer Center
People needed: 0
Starts: 2016-06-22
Expected to finish: 2019-06-15
Last updated by the study team: 2018-12-27

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

HIV-1 seropositive
Stable, continuous antiretroviral treatment for at least three months before enrollment, defined as a multi-drug regimen (excluding azidothymidine [AZT])
HIV plasma viral load < 50 copies/ml
Non-Hodgkin or Hodgkin lymphoma without active central nervous system (CNS) involvement associated with poor prognosis with medical therapy alone or for which autologous peripheral blood stem cell (PBSC) transplant is indicated:
Hodgkin's lymphoma beyond first remission or first partial remission or induction failure with subsequent response to salvage therapy
Non-Hodgkin's lymphoma beyond first remission or first partial remission or induction failure with subsequent response to salvage therapy
Chemotherapy responsive disease
Karnofsky performance score >= 70%
Subjects must agree to use effective contraception from enrollment through completion of the study
Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment
Subjects must be on a prophylactic regimen for pneumocystis carinii pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in peripheral blood
Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

Renal disease: serum creatinine > 2 times upper limit of normal
Liver disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limits of normal, unless determined to be a result of the primary hematologic malignancy
Serum bilirubin greater than 3 times the upper limit of normal, unless attributed to Gilbert's syndrome
Pulmonary disease: forced vital capacity (FVC) < 60% predicted
Pulmonary disease: forced expiratory volume in 1 second (FEV1) < 60% predicted
Pulmonary disease: diffusion capacity of the lung for carbon monoxide (DLCO) parameters < 60% predicted (corrected for hemoglobin)
Cardiac insufficiency: left ventricular ejection fraction (LVEF) < 50% or coronary artery disease requiring treatment
Active infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV)
Hepatitis B surface antigen positive
Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA) with clinical evidence of cirrhosis
Requiring active treatment for Toxoplasma gondii
Planned radiation therapy after transplant
Malignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skin
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian)
A medical history of noncompliance with HAART or medical therapy
Any concurrent or past medical condition that, in the opinion of the Investigator, would exclude the subject from participation or any psychosocial conditions that would hinder study compliance or follow-up, at the discretion of the Investigator
Receipt of a vaccine for HIV-1 or any prior gene modified cell product, at any time
Known hypersensitivity to any of the products used in the trial-G-CSF (Neupogen), plerixafor, or any planned components of conditioning regimens
Pregnant or nursing women

Where it is running

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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