Hodgkins LymphomaPhase 1ALDINCT00383097
Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma
A Phase 1 study testing LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES and LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES in people with Hodgkins Lymphoma and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkins Lymphoma, Non-Hodgkin Lymphoma
- What is being tested?
- LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES and LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Feb 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of EBV-positive Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL; all histological subtypes except Burkitt's lymphoma), or EBV (associated)-T/NK-LPD, or chronic active EBV infection (CAEBV) after second or subsequent relapse including after autologous or syngeneic stem cell transplant (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated). CAEBV is defined as i) illness for greater than 3 months duration (EBV-related illness or symptoms including fever, persistent hepatitis, extensive lymphadenopathy, or hepatosplenomegaly); ii) increased amounts of EBV-DNA in peripheral blood (equal or greater than 400 genome copies per ug of DNA) or abnormal high levels of EBV antibodies (VCA IgG equal or greater than 1:5120 or EA IgG equal or greater than 1:640; and iii) no evidence of previous immunological abnormalities or other recent infection that might explain the observed condition.
- Patients with life expectancy greater than 6 weeks.
- Patients with a Karnofsky score (age ≥16) of greater than 50 or Lansky score (age<16) of greater than 50
- No severe intercurrent infection.
- HIV negative donor (if autologous donor, patient must be HIV negative)
- Patient, parent/guardian able to give informed consent.
Show all 11Show fewer
- Patients with bilirubin less than3 x normal, AST less than 5 x normal, and Hgb greater than 8.0
- Patients with a creatinine less than 2 x normal for age
- Patients should have been off other investigational therapy including T cell therapies for one month prior to entry in this study.
- Female patients with reproductive capacity must have a negative pregnancy test. Women of childbearing potential must not be pregnant and must be on effective birth control. The male partner should use a condom.
- Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator¡¦s discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.
Who cannot join
- Patient, parent/guardian unable or unwilling to give informed consent
- Pregnant women
- Patients with a Karnofsky score of < 50
- Patients with a severe intercurrent infection
- Patients with a life expectancy of <6 weeks
- Patients with a bilirubin greater than 3x normal. AST greater than 5x normal and Hgb less than 8.0 g/dl
Show all 9Show fewer
- Patients with a creatinine greater than 2x normal for age
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
- Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Administration of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma or Chronic Active EBV Infection (ALDI)
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory.
If we are successful in growing these cells and if we feel they would be helpful to the donor, we would then give the cells back to the donor.
Read more
This trial is for patients that have a type of lymph gland cancer called Hodgkin or non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come back or not gone away after treatment, including the best treatment we know.
This is a research study using special immune system cells called LMP1- and LMP2-specific cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of infection with the virus that causes infectious mononucleosis (EBV) before or at the time of their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the patient's blood and affect EBV-positive cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2. These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.
Read the detailed description
Infusions of CD45 MAbs A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used 40, 400ug/kg over 6 to 8 hrs daily x 4 given as daily intravenous infusions that will be completed 48-72 hours prior to CTL infusion. Patients will be premedicated prior to CD45 infusions and monitored as per the SOP for CD45 MAbs infusion.
Day 1 through Day 4: YTH 24/54 400ug/kg over 6 to 8 hr; Day 5: Rest; Day 6, 7 or 8: CTL Infusion (provided CD45 Mab level <100 ng/ml)
Preparation of the Patient:
Oxygen and suction equipment must be available in the room. Emergency drugs (Benadryl, Epinephrine, solucortef to solumedrol) in appropriate doses must be preordered by the physician prior to initiation of each infusion with doses available. A code card containing the appropriate doses of each medicine according to the patient's weight will also be available. Continuous telemetric monitoring by pulse oximeter and EKG will begin prior to and for 6 hours after each antibody infusion has taken place. Baseline vital signs are taken and recorded and monitored as per the SOP for antibody infusions.
MAbs Infusion:
The antibody aliquot to be infused will arrive in the treatment area hand-carried by the attending physician or appointed designate.
The antibody aliquot will be diluted in minimal amounts of normal saline. The resulting solution is stable for 24 hours.
The antibody solution is administered by a syringe pump in incremental doses, 0.2-0.8 mg in the first hour and up to 10 mg/hr thereafter, for a maximum infusion time of 8 hrs. A registered nurse and a physician must be readily available
Antibody toxicity:
Volume Overload: This is of particular importance in small recipients and will be monitored carefully.
Inflammatory mediator release from damaged circulating white cells and allergic reactions: Fever, chills, rigors, pruritis, urticaria, nausea, vomiting, throat tightness and dyspnea may occur. These reactions usually respond to slowing or stopping the infusion and/or the parenteral administration of diphenhydramine, hydrocortisone, meperidine or anti-emetics. Administration of O2, epinephrine, bronchodilators or IPPB may be necessary.
Adverse effects of CD45 MAbs on CTL Our experience to date has shown rapid clearance of CD45 MAbs from the plasma, such that levels are undetectable by 24-48hrs after infusion. However, the MAb levels will be measured before CTL infusion and if free plasma CD45 MAbs are present CTL infusion will be deferred for 24 hours
CTL Infusion:
Dose Levels of CTLs: The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules:
Dose level I: 2 x 10e7 cells/m2; Dose level II: 1 x 10e8 cells/m2; Dose level III: 3 x 10e8 cells/m2; Dose level IV: 1 x 10e9 cells/m2. Patients will be pre-medicated with Benadryl 1mg/kg IV (max 50mg) and Tylenol 10mg/kg po (max 650mg).
Cell Administration: LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
- Conditions
- Hodgkins Lymphoma, Non-Hodgkin Lymphoma
- Being tested
- LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES, LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES
- Keywords
- CTLs, LMP1, LMP2, CYTOTOXIC T-LYMPHOCYTES, CD45, ANTIBODY, EBV-POSITIVE HODGKIN'S, NON-HODGKIN'S LYMPHOMA
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTESGenetic
1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTESGenetic
1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting Toxicity: Two patients in each cohort are followed
Measured: 6 weeks post CTL infusion
Safety: All patients who received CD45 MAbs and LMP1- and LMP2-CTL infusions will be included in the safety analysis of this combination regimen
Measured: 1 year
Secondary outcomes (6)
Laboratory data which includes CBC, BUN, creatinine, etc. will be examined at pre-infusion, and at 1, 2, 4, 6, 8 weeks post- CTL infusion, 3-month intervals for the first year
Measured: 1 year
Frequency of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as T cell specific for CMVpp65 will be measured and summarized at pre and post-infusion time points
Measured: 1 year
Changes of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as for CMVpp65 from pre-infusion to each time point of post-infusion in the overall patient group.
Measured: 1 year
Analysis of immunologic function of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma will be performed at each time point of follow-up and paired comparisons of changes from baseline will be performed.
Measured: 1 year
Frequency of T cells specific for adenovirus and EBV.
Measured: 1 year
Analysis of anti-tumor activity; Overall response rates as well as by dose groups will be presented after the end of CTL infusion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: The trial was terminated in 2010 due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkins LymphomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Stephen Gottschalk, Baylor College of Medicine
- Investigators
- MALCOLM K BRENNER, MD, Study director, Center for Cell and Gene Therapy, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383097
- Sponsor's protocol ID
- 19275
- Other IDs
- ALDI
- Acronym
- ALDI
- Status last verified
- May 2012
- First submitted
- 28 Sep 2006
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma or Chronic Active EBV Infection (ALDI)
- ClinicalTrials.gov ID
- NCT00383097
- Acronym / sponsor ID
- ALDI / 19275
- Conditions
- Hodgkins Lymphoma, Non-Hodgkin Lymphoma
- Keywords
- CTLs, LMP1, LMP2, CYTOTOXIC T-LYMPHOCYTES, CD45, ANTIBODY, EBV-POSITIVE HODGKIN'S, NON-HODGKIN'S LYMPHOMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated in 2010 due to lack of enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Sep 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Oct 2006 (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.
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory.
If we are successful in growing these cells and if we feel they would be helpful to the donor, we would then give the cells back to the donor.
This trial is for patients that have a type of lymph gland cancer called Hodgkin or non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come back or not gone away after treatment, including the best treatment we know.
This is a research study using special immune system cells called LMP1- and LMP2-specific cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of infection with the virus that causes infectious mononucleosis (EBV) before or at the time of their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the patient's blood and affect EBV-positive cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2. These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.
Detailed description
Infusions of CD45 MAbs A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used 40, 400ug/kg over 6 to 8 hrs daily x 4 given as daily intravenous infusions that will be completed 48-72 hours prior to CTL infusion. Patients will be premedicated prior to CD45 infusions and monitored as per the SOP for CD45 MAbs infusion.
Day 1 through Day 4: YTH 24/54 400ug/kg over 6 to 8 hr; Day 5: Rest; Day 6, 7 or 8: CTL Infusion (provided CD45 Mab level <100 ng/ml)
Preparation of the Patient:
Oxygen and suction equipment must be available in the room. Emergency drugs (Benadryl, Epinephrine, solucortef to solumedrol) in appropriate doses must be preordered by the physician prior to initiation of each infusion with doses available. A code card containing the appropriate doses of each medicine according to the patient's weight will also be available. Continuous telemetric monitoring by pulse oximeter and EKG will begin prior to and for 6 hours after each antibody infusion has taken place. Baseline vital signs are taken and recorded and monitored as per the SOP for antibody infusions.
MAbs Infusion:
The antibody aliquot to be infused will arrive in the treatment area hand-carried by the attending physician or appointed designate.
The antibody aliquot will be diluted in minimal amounts of normal saline. The resulting solution is stable for 24 hours.
The antibody solution is administered by a syringe pump in incremental doses, 0.2-0.8 mg in the first hour and up to 10 mg/hr thereafter, for a maximum infusion time of 8 hrs. A registered nurse and a physician must be readily available
Antibody toxicity:
Volume Overload: This is of particular importance in small recipients and will be monitored carefully.
Inflammatory mediator release from damaged circulating white cells and allergic reactions: Fever, chills, rigors, pruritis, urticaria, nausea, vomiting, throat tightness and dyspnea may occur. These reactions usually respond to slowing or stopping the infusion and/or the parenteral administration of diphenhydramine, hydrocortisone, meperidine or anti-emetics. Administration of O2, epinephrine, bronchodilators or IPPB may be necessary.
Adverse effects of CD45 MAbs on CTL Our experience to date has shown rapid clearance of CD45 MAbs from the plasma, such that levels are undetectable by 24-48hrs after infusion. However, the MAb levels will be measured before CTL infusion and if free plasma CD45 MAbs are present CTL infusion will be deferred for 24 hours
CTL Infusion:
Dose Levels of CTLs: The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules:
Dose level I: 2 x 10e7 cells/m2; Dose level II: 1 x 10e8 cells/m2; Dose level III: 3 x 10e8 cells/m2; Dose level IV: 1 x 10e9 cells/m2. Patients will be pre-medicated with Benadryl 1mg/kg IV (max 50mg) and Tylenol 10mg/kg po (max 650mg).
Cell Administration: LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of EBV-positive Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL; all histological subtypes except Burkitt's lymphoma), or EBV (associated)-T/NK-LPD, or chronic active EBV infection (CAEBV) after second or subsequent relapse including after autologous or syngeneic stem cell transplant (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated). CAEBV is defined as i) illness for greater than 3 months duration (EBV-related illness or symptoms including fever, persistent hepatitis, extensive lymphadenopathy, or hepatosplenomegaly); ii) increased amounts of EBV-DNA in peripheral blood (equal or greater than 400 genome copies per ug of DNA) or abnormal high levels of EBV antibodies (VCA IgG equal or greater than 1:5120 or EA IgG equal or greater than 1:640; and iii) no evidence of previous immunological abnormalities or other recent infection that might explain the observed condition.
- Patients with life expectancy greater than 6 weeks.
- Patients with a Karnofsky score (age ≥16) of greater than 50 or Lansky score (age<16) of greater than 50
- No severe intercurrent infection.
- HIV negative donor (if autologous donor, patient must be HIV negative)
Key exclusion criteria (9 listed)
- Patient, parent/guardian unable or unwilling to give informed consent
- Pregnant women
- Patients with a Karnofsky score of < 50
- Patients with a severe intercurrent infection
- Patients with a life expectancy of <6 weeks
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 |
|---|---|---|
| LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2 | Genetic | – |
| LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES1 injection One of the following 4 dose levels: 2x 10^7 cells/m2, 1x 10^8 cells/m2, 3 x 10^8 cells/m2, 1 x 10^9 cells/m2 | Genetic | – |
Primary outcome
Dose limiting Toxicity: Two patients in each cohort are followed
Time frame: 6 weeks post CTL infusion
Safety: All patients who received CD45 MAbs and LMP1- and LMP2-CTL infusions will be included in the safety analysis of this combination regimen
Time frame: 1 year
6 secondary outcomes
Laboratory data which includes CBC, BUN, creatinine, etc. will be examined at pre-infusion, and at 1, 2, 4, 6, 8 weeks post- CTL infusion, 3-month intervals for the first year
Time frame: 1 year
Frequency of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as T cell specific for CMVpp65 will be measured and summarized at pre and post-infusion time points
Time frame: 1 year
Changes of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as for CMVpp65 from pre-infusion to each time point of post-infusion in the overall patient group.
Time frame: 1 year
Analysis of immunologic function of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma will be performed at each time point of follow-up and paired comparisons of changes from baseline will be performed.
Time frame: 1 year
Frequency of T cells specific for adenovirus and EBV.
Time frame: 1 year
Analysis of anti-tumor activity; Overall response rates as well as by dose groups will be presented after the end of CTL infusion.
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The trial was terminated in 2010 due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
MALCOLM K BRENNER, MD study director
Center for Cell and Gene Therapy, Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES and LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES in people with Hodgkins Lymphoma and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 sites 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The trial was terminated in 2010 due to lack of enrollment.). Results are not available in the source record.
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?
Dose limiting Toxicity: Two patients in each cohort are followed (time frame: 6 weeks post CTL infusion). The study lists 2 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 24 May 2012.