Clinical trial · Interventional
Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin Lymphoma
AUTOLOGOUS TRANSPLANTATION AND STEM CELL BASED-GENE THERAPY FOR THE TREATMENT OF HIV-ASSOCIATED LYMPHOMA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies genetically modified peripheral blood stem cell transplant in treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy
Conditions
Conditions (45)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Nasal Type Extranodal NK/T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| AIDS-related Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| AIDS-related Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| AIDS-related Diffuse Small Cleaved Cell Lymphoma | — | UNRESOLVED | — |
| AIDS-related Immunoblastic Large Cell Lymphoma | AIDS-Related Immunoblastic Lymphoma | ALIAS | 0.90 |
| AIDS-related Lymphoblastic Lymphoma | AIDS-Related Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| AIDS-related Peripheral/Systemic Lymphoma | — | UNRESOLVED |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gene modified peripheral blood cell transplant)
- description
- CONDITIONING: Patients receive carmustine IV over 3 hours on day -7, cytarabine IV over 2 hours BID and etoposide IV over 2 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. TRANSPLANTATION: Patients receive an autologous PBSC infusion and/or infusion of autologous transduced hematopoietic cells on day 0. Beginning 28-120 days later, patients eligible for in vivo selection after detection of gene-marked cells receive O6-benzylguanine IV over 1 hour and carmustine IV over 3 hours on days 14, 28, and then monthly until completion of therapy. Patients achieving \> 10% gene marking and CD4 count of \>= 500 cells/uL receive up to 2 courses of structured treatment interruption without undergoing in vivo selection.
- interventionNames
- Drug: carmustine
- Drug: cytarabine
- Drug: melphalan
- Drug: etoposide
- Drug: O6-benzylguanine
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
- Other: laboratory biomarker analysis
Primary outcomes (6)
- measure
- Safety of infusion of gene-modified cells, measured by grade 3 or greater toxicities related to infusion of gene-modified cells using the Common Toxicity Criteria version 4.0(CTCv.4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
Inclusion Criteria: * HIV seropositive * Antiretroviral treatment for at least one month, defined as a multi-drug regimen (excluding azacitidine \[AZT\]) * HIV plasma viral load has decreased by 1.5 logs or viral load \< 5000 copies/ml * Non-Hodgkin or Hodgkin lymphoma without active central nervous system (CNS) involvement associated with poor prognosis with medical therapy alone or for which autologous peripheral blood stem cell (PBSC) transplant is indicated: * Hodgkin's lymphoma beyond first remission; first partial remission; induction failure with subsequent response to salvage therapy * Non-Hodgkin's Lymphoma beyond first remission: first partial remission; induction failure with subsequent response to salvage therapy * Chemotherapy responsive disease * Karnofsky performance score \>= 70% * Subjects must agree to use effective contraception from enrollment through completion of the study * Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of treatment * 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 * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Serum creatinine \> 2 times upper limit of normal * Serum bilirubin greater than 3 times the upper limits of normal, unless determined to be a result of the primary hematologic malignancy or attributed to Gilbert's syndrome * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limits of normal, unless determined to be a result of the primary hematologic malignancy or attributed to Gilbert's syndrome * Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) or diffusion capacity of the lung of carbon monoxide (DLCO) parameters \< 60% predicted (corrected for hemoglobin) * Left ventricular ejection fraction (LVEF) \< 50% or coronary artery disease requiring treatment * Active infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV) * Patients who are hepatitis C virus (HCV) antibody positive or hepatitis B virus (HBV) surface antigen positive must be free of clinical evidence of cirrhosis that would otherwise make them ineligible for HCT, as determined by the Principal Investigator (P.I.) in consultation with the Gastrointestinal Service; patients with HBV and ongoing evidence of viral replication may require therapy prior to receiving high-dose chemotherapy * Positive serology for Toxoplasma gondii AND requiring treatment or with evidence of active infection * Malignancy other than lymphoma, unless 1) in complete remission and more than 5 years from last treatment), or 2) cervical/anal squamous cell carcinoma in situ or 3) superficial basal cell and squamous cell cancers of the skin * History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian) * A medical history of noncompliance with highly active anti-retroviral therapy (HAART) or medical therapy
References
Publications (0)
Data not yet available