Gene Therapy and Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
City of Hope Medical Center
Study ID
NCT02337985
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • AIDS Related Non-Hodgkin Lymphoma
  • AIDS-Related Burkitt Lymphoma
  • AIDS-Related Diffuse Large B-cell Lymphoma
  • AIDS-Related Plasmablastic Lymphoma
  • AIDS-Related Primary Effusion Lymphoma
  • HIV Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Etoposide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells — BIOLOGICAL
    Given IV

Study Details

This pilot clinical trial studies gene therapy following combination chemotherapy in treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma. Placing genes that have been shown in the laboratory to inhibit the growth and spread of the immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the body's ability to fight HIV. Drugs used in chemotherapy 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. Giving gene therapy after combination chemotherapy may improve the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.

Key Dates

Start date
Nov 20, 2015
Status verified
Nov 2025
Primary completion
Sep 8, 2026
Completion
Sep 8, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (R-EPOCH, rHIV7-shI-TAR-CCR5RZ-transduced HSPC)
    Patients receive prednisone PO BID on days 1-5; rituximab IV on day 1; etoposide IV over 96 hours, doxorubicin hydrochloride IV over 96 hours and vincristine sulfate IV over 96 hours on days 1-4; and cyclophosphamide IV over 30-60 minutes on day 5. Patients then receive filgrastim SC QD beginning on day 6 and continuing until absolute neutrophil count recovers. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic stem/progenitor cells IV on day 0 (48 hours after the final combination chemotherapy course.)

Primary Outcome Measure

Incidence of adverse events related to R-EPOCH, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 2 years after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
NCI Lymphoid Malignancies BranchBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
HIV
By specialty
Infectious disease
By research site
NCI Lymphoid Malignancies Branch· Bethesda, MD

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