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Virus Therapy

Gene Therapy After Chemotherapy for AIDS-Related Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Amrita Krishnan

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be on a prophylactic regimen for Pneumocystis carinii pneumonia, or agree to begin such treatment, if the cluster of differentiation (CD)4 counts are < 200 cells/uL

If the subject is female and of child-bearing potential, subject must have negative serum or urine pregnancy test within 7 days of treatment with research agent; men with partners of child-bearing potential and women of child-bearing potential must be willing to use medically effective birth control methods, e.g. contraceptive pill, condom, or diaphragm and continue this for one year post HSPC infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new gene therapy for AIDS-related NHL, which uses chemotherapy to help the new cells work better.

Who is the study for?

This trial is for adults with AIDS-related non-Hodgkin lymphoma who've finished frontline chemotherapy. They must have normal liver and kidney function, understand the study, and consent to it. Women of childbearing age need a negative pregnancy test and agree to birth control. Participants can't join if they have uncontrolled illnesses, other cancers, certain infections like active hepatitis or CMV retinitis, or are pregnant.Check my eligibility

What is being tested?

The trial tests gene therapy using stem cells modified with anti-HIV RNA after busulfan chemotherapy in patients with AIDS-related NHL. The goal is to see if these modified cells can help the body fight AIDS more effectively.See study design

What are the potential side effects?

Potential side effects include reactions related to busulfan such as nausea, fatigue, mouth sores; gene therapy may cause immune responses or infusion-related reactions. Side effects from stem cell collection could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on, or agree to start, treatment to prevent a specific type of pneumonia due to my low CD4 count.

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I am not pregnant and agree to use birth control during and for a year after treatment.

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I do not have serious heart disease or heart failure.

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I have a type of non-Hodgkin lymphoma, not T-cell, confirmed by biopsy.

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It has been more than 28 days since I finished my first round of chemotherapy for NHL.

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My non-Hodgkin lymphoma has been in complete remission for less than a year, confirmed by a recent scan.

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I have completed a specific cell collection process and have enough cells for backup and research.

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The treatment I'm considering has passed all its safety and quality tests.

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I was HIV positive when or before my lymphoma was diagnosed.

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My liver function tests are within the required range.

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My heart pumps blood effectively.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Procedure related toxicity as determined by adverse events (AE) grading scale using the Common Terminology Criteria for Adverse Events (CTCAE) version v4.03

Time to Absolute Neutrophil Count (ANC) >= 500/uL

Time to platelet recovery to >= 50,000/uL

Secondary outcome measures

Ability to obtain suitable numbers of transduced HSPC for engraftment assessed by FACS

Effect of ATI on HIV markers and CD4 count

Evidence for and duration of vector-marked PBMC/marrow cells assessed by PCR

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (gene therapy)Experimental Treatment4 Interventions

Patients receive busulfan IV over 3 hours on day -2 followed by lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells IV on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

busulfan

1999

Completed Phase 3

~3630

lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells

2007

Completed Phase 1

~10

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,457 Total Patients Enrolled

Amrita KrishnanPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01961063 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (gene therapy)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells Highlights & Side Effects. Trial Name: NCT01961063 — Phase 1

Lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01961063 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of fifty qualified to partake in this experiment?

"According to the stated requirement, this clinical trial has an 18 year old lower limit and a 65 year old upper limit."

Answered by AI

What is the approximate size of the patient cohort enrolled in this clinical trial?

"This trial has ceased recruitment; the study was first announced on December 31st, 2015 and its details were last modified on February 17th 2022. However, there are 1,981 trials related to HIV that need participants and 98 drug studies actively searching for patients."

Answered by AI

What purpose does this medical experiment aim to accomplish?

"During this 90 day trial, the primary goal is to assess any potential detrimental effects of the medication by evaluating adverse events with CTCAE v4.03. Additionally, secondary objectives include measuring vector-marked PBMC/marrow cells through PCR testing, determining how ATI impacts HIV markers and CD4 count in patients' PBMCs, as well as ensuring a minimum number of transduced HSPC for engraftment via FACS analysis (7.5 x 10e6 cells/kg). The final cell product should contain >= 2.0 x 10e6 CD34+ cells/kg with total viability being greater than"

Answered by AI

What health risks may patients face when participating in a pharmaceutical research program?

"The safety of this pharmacological study is rated at a 1 due to the Phase 1 nature of this trial. As such, there are limited data regarding both efficacy and security available."

Answered by AI

Does this investigation have any vacancies for potential participants?

"According to clinicaltrials.gov, this research project is not currently accepting new participants; it was first shared on December 31st 2015 and last updated on February 17th 2022. Nevertheless, there are 2079 other medical trials recruiting patients presently."

Answered by AI

What are the qualifications for potential participants in this trial?

"To be considered for this research project, participants must have HIV and fall between the ages of 18-65. Aspiring enrollees should note that only 3 patients are sought after at this time."

Answered by AI

What medical issues are commonly addressed through pharmacological research?

"Through pharmacological research, physicians can address various medical conditions including allogeneic hematopoietic stem cell transplantation, chronic myelogenous leukemia, conditioning regimens for allogeneic stem cell transplant therapy, and thrombocythemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

2015. "Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01961063.

All > Aids