Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
AUTOLOGOUS TRANSPLANTATION AND STEM CELL BASED-GENE THERAPY FOR THE TREATMENT OF HIV-ASSOCIATED LYMPHOMA
This clinical trial studies genetically modified peripheral blood stem cell transplant in treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of infusing gene-modified, human immunodeficiency
virus (HIV)-protected hematopoietic stem cells (HSC) after high-dose chemotherapy for
treatment of acquired immunodeficiency syndrome (AIDS)-related lymphoma.
II. To determine the dose of carmustine (BCNU) in combination with O^6-benzylguanine (O6BG)
that results in selection in vivo of gene-modified HIV-resistant cells.
III. To estimate the effect of HIV infection on the presence of HIV-resistant blood cells as
measured by genetic marking for vector sequences before and after antiviral treatment
interruption.
SECONDARY OBJECTIVES:
I. Evaluate the molecular and clonal composition of gene-modified cells after hematopoietic
cell transplant (HCT).
II. Evaluate the molecular and clonal composition of gene-modified cells after O6BG/BCNU.
III. Determine the correlation of the level of O6-methylguanine- methyltransferase (MGMT)
(P140K) marking with toxicity and response.
IV. Characterize the toxicity associated with in vivo selection. V. Determine the efficacy
of the procedure for treatment of lymphoma: defined as time to disease progression,
progression-free survival, treatment-related mortality, time to neutrophil and platelet
recovery, and incidence of infections.
TERTIARY OBJECTIVES:
I. Effect of procedure on the latent HIV reservoir. II. Effect of procedure on HIV-specific
immune reconstitution.
OUTLINE:
CONDITIONING: Patients receive carmustine intravenously (IV) over 3 hours on day -7,
cytarabine IV over 2 hours twice daily (BID) and etoposide IV over 2 hours BID on days -6 to
-3, and melphalan IV over 30 minutes on day -2.
TRANSPLANTATION: Patients receive an autologous PBSC infusion and/or infusion of autologous
transduced hematopoietic cells on day 0.
Beginning 28-120 days later, patients eligible for in vivo selection after detection of
gene-marked cells receive O6-benzylguanine IV over 1 hour and carmustine IV over 3 hours on
days 14, 28, and then monthly until completion of therapy. Patients achieving > 10% gene
marking and CD4 count of >= 500 cells/uL receive up to 2 courses of structured treatment
interruption without undergoing in vivo selection.
After completion of study treatment, patients are followed up periodically for 15 years.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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