LymphomaPhase 1NCT00569985
Gene Therapy-Treated Stem Cells in Treating Patients Undergoing Stem Cell Transplant for Intermediate-Grade or High-Grade AIDS-Related Lymphoma
A Phase 1 study testing lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, carmustine and cyclophosphamide in people with Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This pilot clinical trial studies biological therapy in treating patients with acquired immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, carmustine and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 12 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV seropositive at or before the time of lymphoma diagnosis
- Anti-HIV chemotherapy; subjects must be on a multi-drug regimen (excluding azidothymidine) and have an HIV viral load < 50,000 copies/ml by reverse transcriptase-polymerase chain reaction (RT-PCR) at the time of study enrollment
- Subjects must agree to have their anti-HIV regimen temporarily stopped, and then all subjects will stop antiretroviral therapy (ART) for approximately 7 days at the time they start filgrastim (G-CSF) post-chemotherapy for peripheral blood progenitor cell (PBPC) mobilization and until the mobilization is complete; in addition, if/when the CD4 counts return to a level of 450/mm^3 with undetectable HIV levels in blood, the subjects will undergo an analytic treatment interruption for an indefinite period not to exceed 6 months
- Karnofsky performance status >= 70%
- Biopsy proven intermediate grade or high-grade non-Hodgkin's lymphoma, including plasmablastic lymphoma, primary effusion lymphoma, or biopsy-proven Hodgkin's lymphoma (entities as defined in the World Health Organization [WHO] classification); tissue histology will be reviewed at the City of Hope; patients with prior marrow involvement must demonstrate =< 10% involvement pre-stem cell collection
- No psychosocial conditions that would hinder study compliance and follow-up
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- Pretreatment serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =< 2.5 x institutional upper limit of normal (ULN)
- Serum bilirubin =< 2.5 x institutional ULN
- 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 (PI) in consultation with the Gastrointestinal Service at City of Hope; patients with HBV and ongoing evidence of viral replication may require therapy prior to receiving high-dose chemotherapy
- Serum creatinine =< 2 x institutional ULN and a 24 hour urine creatinine clearance >= 60 cc/min
- Prothrombin time (PT)/partial thromboplastin time (PTT) =< 2 x normal
- Forced expiratory volume in 1 second (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
- Left ventricular ejection fraction (LVEF) >= 50% (by 2-dimensional [2-D] echocardiogram or multigated acquisition scan [MUGA]); absence of cardiomyopathy, congestive heart failure or dysrhythmia
- 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 HCT
- Subjects must be on a prophylactic regimen for Pneumocystis carinii pneumonia, or agree to begin such treatment, if the CD4 counts are =< 200
- ELIGIBILITY CRITERIA (HODGKIN LYMPHOMA) - First or greater relapse after initial complete remission; or partial remission; or induction failure that responds to salvage therapy with stable disease, partial remission, or complete remission (i.e. chemosensitive disease)
- ELIGIBILITY CRITERIA (NON-HODGKIN LYMPHOMA):
- First complete remission with high risk features as specified by the International Prognostic Index, or Relapse after prior complete remission; partial remission; or induction failure that responds to salvage therapy with stable disease, partial remission, or complete remission (i.e. chemosensitive disease)
- SECONDARY ELIGIBILITY CRITERIA:
- Subjects must complete both the therapeutic and research phases of the G-CSF mobilization of peripheral blood progenitor cells and
- Subjects must have collected at least 5 x 10^6 CD34+ cells/kg for the research phase of the collections
Who cannot join
- Presence of detectible HIV-1 that has C-X-C chemokine receptor type 4 (CXCR4)-tropism
- Any symptomatic bacteria or fungal infection
- AIDS related opportunistic infections within the past year for which treatment has been unsuccessful would be considered exclusionary but on a case-by-case basis as determined by the PI
- Active cytomegalovirus (CMV) retinitis or other active CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
- Relapse of Pneumocystis carinii pneumonia within the past year
- Intractable and severe diarrhea, defined as > 1500 cc diarrheal fluid per day, or diarrhea causing persistent severe electrolyte abnormalities or hypoalbuminemia
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- Other AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HCT, as determined by the PI
- History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy
- Pregnant or nursing women
- Any prior malignancy, except those treated with curative intent that are five years from treatment or cervical and anal squamous cell cancers or superficial basal cell and squamous cell cancers of skin
- Active central nervous system (CNS) lymphoma; patients with a history of positive cerebrospinal fluid cytology that has become negative with intrathecal chemotherapy are eligible
- Abnormal cytogenetics not related to the lymphoma
- History of myocardial infarction or congestive heart failure
- Any 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)
- Any medical or physical contraindication or other inability to undergo HPC-apheresis (HPC-A) collection
- Elevated amylase or lipase SGOT, SGPT > 2.5 x the institutional ULN
- Serum bilirubin > 2.5 x ULN
- Any other laboratory value for complete blood count (CBC) and chemistry panel > 2 x ULN
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: A Pilot Study of Safety and Feasibility of Stem Cell Therapy for Aids Lymphoma Using Stem Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs
This pilot clinical trial studies biological therapy in treating patients with acquired immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving chemotherapy before a 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. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving biological therapy as part of the stem cell transplant may be more effective in treating patients with AIDS-related lymphoma
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of using lentivirus-transduced hematopoietic progenitor cells (HPCs) (lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells) in the setting of autologous hematopoietic cell transplantation (HCT) for treatment of AIDS related lymphoma. The safety of the of the genetically modified product used in the transplant procedure will be assessed by monitoring each subject for adverse events (procedure related toxicity); absolute neutrophil count (ANC)/platelet engraftment (sustained recovery); and evidence of replication competent vector or vector recombination with the human immunodeficiency virus (HIV) quasi-species present in the patient.
II. To determine the quantity and duration of vector-marked peripheral blood cells and to characterize: the duration and level of gene marking and expression of the anti-HIV ribonucleic acids (RNAs) in these transduced cells, and the characterization of the integration sites of vector sequences in circulating cells if there is a clinical syndrome suggestive of a clonal expansion of hematopoietic cells. In addition, the feasibility of the process will be assessed based on the results of the release testing of the transduced cells prior to injection into the patient.
III. To determine whether the design of the vector prevents vector mobilization and rescue by wild-type HIV-1. IV. To measure the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after antiviral treatment interruption.
OUTLINE:
CONDITIONING: Patients receive carmustine intravenously (IV) over 1-2 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.
TRANSPLANTATION: Patients undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound cluster of differentiation (CD)34+ cells IV on day 0. After completion of study treatment, patients are followed up every 2 weeks for 3 months; at 4, 6, 8, 10, 12, 18, and 24 months; every 6 months for 3 years; and then annually for 10 years.
- Conditions
- Lymphoma
- Being tested
- lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, carmustine, cyclophosphamide, etoposide, autologous hematopoietic stem cell transplantation
- Keywords
- AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, HIV-associated Hodgkin lymphoma, Treatment Experienced
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cellsBiological
Also called lentivirus-transduced hematopoietic progenitor cells
Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
carmustineDrug
Also called BCNU, BiCNU, bis-chloronitrosourea
Given IV
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
autologous hematopoietic stem cell transplantationProcedure or surgery
Undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment (autologous HCT) | Experimental | CONDITIONING: Patients receive carmustine IV over 1-2 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. TRANSPLANTATION: Patients undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells IV on day 0. Receives: Biological: lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells; Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment using the National Cancer Institute (NCI) hematologic Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
The toxicities observed after each stem cell infusion will be summarized in terms of type (organ affected or laboratory determination such as ANC), severity (by NCI CTCAE version 3 and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility of outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Measured: 15 years post stem cell infusion
Survival of shI-TAR-CCR5RZ-marked cells in the peripheral blood, demonstrated by presence of transgene by Q-PCR using primers specific for rHIV7-shI-TAR-CCR5RZ in serial samples of peripheral blood
Measured: 24 months post stem cell infusion
Determination of RNA transgene expression in samples of peripheral blood mononuclear cells (PBMCs) or marrow before and after infusion, analyzed by Northern blotting/hybridization
For detection of the shRNA, we will use a quantitative real-time PCR assay.
Measured: Day 1 post stem cell infusion
Analysis of vector rescue by HIV
Integration analysis will be performed only if there is a clinical syndrome that suggests clonal expansion of hematopoietic cells. In that situation, the method of insertion site location will use a linear amplification mediated (LAM)-PCR technique. If positive vector sequences are found in the plasma, confirmation of vector rescue will be done by isolation of HIV and subsequent HIV sequencing.
Measured: 15 years post stem cell infusion
Ability to obtain suitable numbers of lentiviral vector treated HPC-A
The number and type of cells will be determined by fluorescence-activated cell sorting (FACS) analysis of the final cell product. Target number for untransduced cells in the final therapeutic cell product is 2.5 x 10^6 CD34+ cells/kg. Minimum target number of CD34+ cells for transduction is 5 x 10^6/kg and in the final transduced cell product, the number of CD34+ cells must be >= 2.0 x 10^6 CD34+ cells/kg with total viability >= 70%. The relative or absolute number of transduced CD34+ cells will be determined.
Measured: Day 2 post apheresis
Determination of replication competent lentivirus (RCL) and HIV-1/vector recombination
Measured: 15 years post stem cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startJun 2007
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amrita Y. Krishnan, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569985
- Sponsor's protocol ID
- 04047
- Other IDs
- CHNMC-04047, NCI-2012-00437, 04047
- Status last verified
- Nov 2019
- First submitted
- 7 Dec 2007
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Safety and Feasibility of Stem Cell Therapy for Aids Lymphoma Using Stem Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs
- ClinicalTrials.gov ID
- NCT00569985
- Acronym / sponsor ID
- 04047
- Conditions
- Lymphoma
- Keywords
- AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, HIV-associated Hodgkin lymphoma, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies biological therapy in treating patients with acquired immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving chemotherapy before a 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. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving biological therapy as part of the stem cell transplant may be more effective in treating patients with AIDS-related lymphoma
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of using lentivirus-transduced hematopoietic progenitor cells (HPCs) (lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells) in the setting of autologous hematopoietic cell transplantation (HCT) for treatment of AIDS related lymphoma. The safety of the of the genetically modified product used in the transplant procedure will be assessed by monitoring each subject for adverse events (procedure related toxicity); absolute neutrophil count (ANC)/platelet engraftment (sustained recovery); and evidence of replication competent vector or vector recombination with the human immunodeficiency virus (HIV) quasi-species present in the patient.
II. To determine the quantity and duration of vector-marked peripheral blood cells and to characterize: the duration and level of gene marking and expression of the anti-HIV ribonucleic acids (RNAs) in these transduced cells, and the characterization of the integration sites of vector sequences in circulating cells if there is a clinical syndrome suggestive of a clonal expansion of hematopoietic cells. In addition, the feasibility of the process will be assessed based on the results of the release testing of the transduced cells prior to injection into the patient.
III. To determine whether the design of the vector prevents vector mobilization and rescue by wild-type HIV-1. IV. To measure the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after antiviral treatment interruption.
OUTLINE:
CONDITIONING: Patients receive carmustine intravenously (IV) over 1-2 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2.
TRANSPLANTATION: Patients undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound cluster of differentiation (CD)34+ cells IV on day 0. After completion of study treatment, patients are followed up every 2 weeks for 3 months; at 4, 6, 8, 10, 12, 18, and 24 months; every 6 months for 3 years; and then annually for 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (autologous HCT) | Experimental | Biological: lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, Drug: carmustine, Drug: cyclophosphamide, Drug: etoposide, Procedure: autologous hematopoietic stem cell transplantationCONDITIONING: Patients receive carmustine IV over 1-2 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. TRANSPLANTATION: Patients undergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells IV on day 0. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- HIV seropositive at or before the time of lymphoma diagnosis
- Anti-HIV chemotherapy; subjects must be on a multi-drug regimen (excluding azidothymidine) and have an HIV viral load < 50,000 copies/ml by reverse transcriptase-polymerase chain reaction (RT-PCR) at the time of study enrollment
- Subjects must agree to have their anti-HIV regimen temporarily stopped, and then all subjects will stop antiretroviral therapy (ART) for approximately 7 days at the time they start filgrastim (G-CSF) post-chemotherapy for peripheral blood progenitor cell (PBPC) mobilization and until the mobilization is complete; in addition, if/when the CD4 counts return to a level of 450/mm^3 with undetectable HIV levels in blood, the subjects will undergo an analytic treatment interruption for an indefinite period not to exceed 6 months
- Karnofsky performance status >= 70%
- Biopsy proven intermediate grade or high-grade non-Hodgkin's lymphoma, including plasmablastic lymphoma, primary effusion lymphoma, or biopsy-proven Hodgkin's lymphoma (entities as defined in the World Health Organization [WHO] classification); tissue histology will be reviewed at the City of Hope; patients with prior marrow involvement must demonstrate =< 10% involvement pre-stem cell collection
Key exclusion criteria (18 listed)
- Presence of detectible HIV-1 that has C-X-C chemokine receptor type 4 (CXCR4)-tropism
- Any symptomatic bacteria or fungal infection
- AIDS related opportunistic infections within the past year for which treatment has been unsuccessful would be considered exclusionary but on a case-by-case basis as determined by the PI
- Active cytomegalovirus (CMV) retinitis or other active CMV-related organ dysfunction; patients with a history of treated CMV infection are not excluded
- Relapse of Pneumocystis carinii pneumonia within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cellsAlso: lentivirus-transduced hematopoietic progenitor cellsUndergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells | Biological | Treatment (autologous HCT) |
| carmustineAlso: BCNU, BiCNU, bis-chloronitrosoureaGiven IV | Drug | Treatment (autologous HCT) |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV | Drug | Treatment (autologous HCT) |
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Treatment (autologous HCT) |
| autologous hematopoietic stem cell transplantationUndergo autologous hematopoietic stem cell transplantation comprising lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells and non-bound CD34+ cells | Procedure or surgery | Treatment (autologous HCT) |
Primary outcome
Safety of treatment using the National Cancer Institute (NCI) hematologic Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: 15 years post stem cell infusion
The toxicities observed after each stem cell infusion will be summarized in terms of type (organ affected or laboratory determination such as ANC), severity (by NCI CTCAE version 3 and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility of outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Survival of shI-TAR-CCR5RZ-marked cells in the peripheral blood, demonstrated by presence of transgene by Q-PCR using primers specific for rHIV7-shI-TAR-CCR5RZ in serial samples of peripheral blood
Time frame: 24 months post stem cell infusion
Determination of RNA transgene expression in samples of peripheral blood mononuclear cells (PBMCs) or marrow before and after infusion, analyzed by Northern blotting/hybridization
Time frame: Day 1 post stem cell infusion
For detection of the shRNA, we will use a quantitative real-time PCR assay.
Analysis of vector rescue by HIV
Time frame: 15 years post stem cell infusion
Integration analysis will be performed only if there is a clinical syndrome that suggests clonal expansion of hematopoietic cells. In that situation, the method of insertion site location will use a linear amplification mediated (LAM)-PCR technique. If positive vector sequences are found in the plasma, confirmation of vector rescue will be done by isolation of HIV and subsequent HIV sequencing.
Ability to obtain suitable numbers of lentiviral vector treated HPC-A
Time frame: Day 2 post apheresis
The number and type of cells will be determined by fluorescence-activated cell sorting (FACS) analysis of the final cell product. Target number for untransduced cells in the final therapeutic cell product is 2.5 x 10^6 CD34+ cells/kg. Minimum target number of CD34+ cells for transduction is 5 x 10^6/kg and in the final transduced cell product, the number of CD34+ cells must be >= 2.0 x 10^6 CD34+ cells/kg with total viability >= 70%. The relative or absolute number of transduced CD34+ cells will be determined.
Determination of replication competent lentivirus (RCL) and HIV-1/vector recombination
Time frame: 15 years post stem cell infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Y. Krishnan, MD study chair
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells, carmustine and cyclophosphamide in people with Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of treatment using the National Cancer Institute (NCI) hematologic Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (time frame: 15 years post stem cell infusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019; AzTrials last refreshed its copy on 26 Oct 2026.