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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

Must not have

Patients should not have any uncontrolled illness including ongoing or active infection other than HIV

Any medical or physical contraindication or other inability to undergo HSPC collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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

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I do not have serious heart disease or heart failure.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses or active infections, except for HIV.

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I cannot undergo stem cell collection due to health reasons.

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I have not had HIV-related brain issues, dementia, or seizures in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

HIV integration analysis by number of reads and loci

Awards & 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 (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

~2500

Rituximab

1999

Completed Phase 4

~2990