← Back to Search

Anti-tumor antibiotic, Anti-metabolites, Alkylating agents, Corticosteroid

Gene Therapy + Chemotherapy for AIDS-Related Lymphoma

Phase 1

Waitlist Available

Led By Amrita Krishnan, MD

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

Biopsy proven lymphoma for which rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (R-EPOCH) is appropriate frontline therapy, e.g., Burkitt lymphoma or diffuse large B-cell lymphoma (DLBCL) NHL, including plasmablastic lymphoma and primary effusion lymphoma but not T-cell lymphoma; tissue histology will be reviewed at the treating institution

Patients must demonstrate >= 75% disease reduction on computed tomography (CT) scan (confirmed by PET scan) after the third cycle of R-EPOCH relative to baseline, with no evidence of disease progression after the fifth cycle

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years, possibly up to 15 years

Awards & highlights

Study Summary

This trial is studying gene therapy following combination chemotherapy to treating patients with AIDS-related non-Hodgkin lymphoma.

Who is the study for?

This trial is for HIV-positive patients with specific types of AIDS-related non-Hodgkin lymphoma, who have not had other cancers (except certain skin cancers or those treated curatively over 2 years ago), no history of severe brain conditions or seizures, and are not pregnant. They must be able to follow the study plan, use effective birth control, and show a significant reduction in their lymphoma after initial chemotherapy.Check my eligibility

What is being tested?

The trial tests gene therapy combined with chemotherapy in AIDS-related non-Hodgkin lymphoma patients. It involves inserting genes that may inhibit HIV into stem cells after standard chemo drugs like rituximab and doxorubicin. The goal is to see if this can boost the body's fight against both cancer and HIV.See study design

What are the potential side effects?

Possible side effects include reactions related to gene therapy such as immune responses or infection risks, typical chemo side effects like nausea, hair loss, fatigue, increased risk of infections due to low blood cell counts, and potential organ damage from drug toxicity.

Eligibility Criteria

Inclusion Criteria

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

Select...

My lymphoma is confirmed by biopsy and suitable for R-EPOCH treatment.

Select...

My scans show at least 75% reduction in my disease after treatment, with no worsening.

Select...

I am able to get out of my bed or chair and move around.

Select...

I do not have serious heart disease or heart failure.

Select...

I have completed a specific cell collection process and gathered enough cells for my treatment.

Select...

I am taking or agree to take medication to prevent a specific type of pneumonia until my immune cells recover.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years, possibly up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years, possibly up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years, possibly up to 15 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

Ability to obtain suitable numbers of lentiviral vector treated HSPC as determined by cell count

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

Incidence of adverse events related to lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic stem/progenitor cells infusion, graded using the NCI CTCAE version 4.03

+1 more

Secondary outcome measures

Change in of shI-TAR-CCR5RZ-marked cells in bone marrow

HIV integration analysis by number of reads and loci

HIV reservoir as determined by HIV-1 reverse transcriptase (RT)-PCR, DNA PCR, and DNA 2 long terminal repeat circle PCR

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (R-EPOCH, rHIV7-shI-TAR-CCR5RZ-transduced HSPC)Experimental Treatment8 Interventions

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.)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Rituximab

1999

Completed Phase 4

~1880

Etoposide

2010

Completed Phase 3

~2440

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Vincristine Sulfate

2005

Completed Phase 3

~10110

Cyclophosphamide

1995

Completed Phase 3

~3770

Filgrastim

2000

Completed Phase 3

~3670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,657 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,450 Total Patients Enrolled

Amrita Krishnan, MDPrincipal InvestigatorCity of Hope Medical Center

2 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Etoposide, Cyclophosphamide (Anti-tumor antibiotic, Anti-metabolites, Alkylating agents, Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02337985 — Phase 1

Primary Effusion Lymphoma Research Study Groups: Treatment (R-EPOCH, rHIV7-shI-TAR-CCR5RZ-transduced HSPC)

Primary Effusion Lymphoma Clinical Trial 2023: Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Etoposide, Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02337985 — Phase 1

Frequently Asked Questions

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

Is the protocol for this study encompassing individuals over 80 years of age?

"This experiment only allows participants aged 18 to 65. Conversely, there are 809 trials for minors and 3112 experiments dedicated to the elderly demographic."

Answered by AI

What is the uppermost participant count for this medical study?

"This study is not accepting any more participants. Initially posted on November 20th 2015, it was last updated on July 31st 2022. There are a variety of other trials that may be suitable for individuals with lymphoma, primary effusion and Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells - 2016 and 1639 respectively."

Answered by AI

Is enrollment for this investigation accessible to participants at the moment?

"This trial has ceased its recruitment drive, being last edited on July 31st 2022. Should you be searching for similar studies related to lymphoma or primary effusion, there are currently 2016 trials actively accepting participants; in addition, 1639 Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells studies have open enrolment requirements."

Answered by AI

Have any prior investigations explored the impact of Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells?

"At present, there are 1639 ongoing studies examining the efficacy of Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells with 358 trials in Phase 3. Of these investigations, many were instituted out of Bethesda, Maryland; yet globally 60302 sites have lent their facilities to such research."

Answered by AI

What potential risks could patients face with the administration of Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells?

"Due to the limited clinical research, our team assigned Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells a score of 1 on safety. This assessment is based on this drug's Phase 1 trial status which suggests there is only minor evidence supporting its efficacy and security."

Answered by AI

What is the primary purpose of Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells treatments?

"Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells is predominantly used to combat merkel cell cancer, but has also proven effective in the treatment of leukemia, ophthalmia, sympathetic and prostate cancers."

Answered by AI

Am I eligible to take part in this research study?

"This medical trial requires potential participants to meet three criteria: having lymphoma, primary effusion and being of legal age. The research team is looking for 10 volunteers in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Gene Therapy and Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02337985.

All > Aids