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HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection

NCT02343666 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-11-20

No results posted yet for this study

Summary

This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.

Conditions

  • Human Immunodeficiency Virus 1 Positive
  • Stage I Adult Hodgkin Lymphoma
  • Stage I Adult Non-Hodgkin Lymphoma
  • Stage II Adult Hodgkin Lymphoma
  • Stage II Adult Non-Hodgkin Lymphoma
  • Stage III Adult Hodgkin Lymphoma
  • Stage III Adult Non-Hodgkin Lymphoma
  • Stage IV Adult Hodgkin Lymphoma
  • Stage IV Adult Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs

Given IV

DRUG

Carmustine

Given IV

BIOLOGICAL

Filgrastim

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

O6-Benzylguanine

Given IV

DRUG

Plerixafor

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Mazyar Shadman · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2020-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343666 on ClinicalTrials.gov