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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Procedure related toxicity as determined by adverse events (AE) grading scale using the Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,539 Total Patients Enrolled
Amrita KrishnanPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on, or agree to start, treatment to prevent a specific type of pneumonia due to my low CD4 count.I am not pregnant and agree to use birth control during and for a year after treatment.I do not have serious heart disease or heart failure.I do not currently have an active CMV infection affecting my eyes or other organs.I am allergic to certain medications similar to G-CSF, plerixafor, or busulfan.I do not have any active cancer other than skin cancer.I do not have any uncontrolled illnesses or active infections.I am not currently on any experimental treatments or other cancer therapies.I am positive for active hepatitis B or C infection.I have a type of non-Hodgkin lymphoma, not T-cell, confirmed by biopsy.It has been more than 28 days since I finished my first round of chemotherapy for NHL.My non-Hodgkin lymphoma has been in complete remission for less than a year, confirmed by a recent scan.I have completed a specific cell collection process and have enough cells for backup and research.The treatment I'm considering has passed all its safety and quality tests.I don't have active brain lymphoma, dementia, recent seizures, or HIV-related brain issues but am eligible if I had positive spinal fluid tests that are now negative and have been in remission for 12 months.I was HIV positive when or before my lymphoma was diagnosed.My liver function tests are within the required range.My heart pumps blood effectively.I am able to care for myself but may not be able to do active work.I cannot undergo stem cell collection due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gene therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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