Advanced CancersPhase 1NCT01653717
CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study testing Leukapheresis, Fludarabine and Cyclophosphamide in people with Advanced Cancers and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Cancers, Leukemia
- What is being tested?
- Leukapheresis, Fludarabine 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2013to 7 Aug 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of B-CLL, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
- Confirmed history of CD19 positivity by flow cytometry.
- At least 8 weeks from last cytotoxic chemotherapy. Patients may continue ibrutinib or lenalidomide. These drugs will be discontinued 1 week prior to start of lymphodepleting chemotherapy.
- Karnofsky Performance Scale > 60%.
- Absolute lymphocyte count >100/uL.
- Adequate hepatic function, as defined by serum glutamate pyruvate (SGPT) <3 x upper limit of normal; serum bilirubin and alkaline phosphatase <2 x upper limit of normal, or considered not clinically significant by the study doctor or designee.
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- Able to provide written informed consent.
- 18-80 years of age.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study.
Who cannot join
- Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
- Presence of autoimmune phenomenon (AIHA, ITP) requiring steroid therapy.
- Presence of Grade 3 or greater toxicity from the previous treatment.
- Concomitant use of other investigational agents (ibrutinib or lenalidomide are allowed).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL)
The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied.
The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of genetically changed T cells, based on when you joined this study. Up to 4 dose levels of T cells will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose of than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T cells is found.
All participants will receive the same dose of chemotherapy.
T Cell Collection (leukapheresis or standard blood draw):
Within 30 days after you have completed the screening tests, you will have leukapheresis performed at the Apheresis Clinic at MD Anderson.
Before the leukapheresis:
- You will have a physical exam, including measurement of your height, weight, and vital signs.
- Your medical history will be recorded.
- Blood (about 4 tablespoons) will be drawn for routine tests and to measure levels of certain proteins.
A leukapheresis is a procedure used to remove blood from the body so that specific blood cells, such as T cells, can be collected. After the specific cells have been collected, the remaining blood is returned to the body.
To perform a leukapheresis, blood will be drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then the remaining blood will be returned back to you through a needle in a vein in the other arm. The procedure will take about 3 hours to complete.
If the doctor thinks it is in your best interest, instead of having a leukapheresis, blood (about 13.5 tablespoons) will be drawn to collect white blood cells instead.
If certain types of unwanted T cells are growing too much, an investigational device called a CliniMACS® system will be used to filter out the unwanted T cells using a magnet.
It will take about 7 weeks to modify and grow the necessary number of genetically modified T cells in the lab. If researchers are not able to collect enough T cells for your assigned dose level, you will be taken off study. Other options will be discussed with you by your doctor.
Chemotherapy:
Before you receive the T cell infusion, you will receive your standard chemotherapy with fludarabine and cyclophosphamide through a catheter (plastic tube) inserted into a large chest vein or through an intravenous needle (IV) inserted in a vein in your arm.
Fludarabine will be given by vein over 30 minutes daily for 3 days.
Cyclophosphamide will be given by vein over 3 hours daily for 3 days.
Study Tests Before the T cell Infusion:
Within 60 days before the T cell infusion:
- You will be asked about any side effects that you may have had.
- Blood (about 2 tablespoons) will be drawn for tests to look at your DNA to check the status of the disease. This may be performed any time before or during the study.
- Mouse protein antibodies are used in the gene transfer process. If your body becomes immune to these proteins, your body may develop antibodies against the mouse antibodies (called "human anti-mouse antibodies" or HAMA). Part of the blood sample will be used to compare against another sample of blood collected after the gene transfer is complete to check for HAMA.
- You will have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan to check your heart function.
- You will have lung function tests.
- If the study doctor thinks it is needed, you will have a bone marrow biopsy/aspiration to check the status of the disease. To collect a bone marrow biopsy/aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.
- If the study doctor thinks it is needed, you will have computed tomography (CT) scans and/or positron emission tomography (PET) scans to check the status of the disease.
Within 7 days before starting chemotherapy:
- You will have a physical exam, including measurement of your weight, and vital signs.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any side effects that you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests. Part of this blood sample will be used for a pregnancy test if you are able to become pregnant. To continue your participation in this study, you cannot be pregnant.
T-cell Infusion (gene transfer):
The T cell infusion will be given by vein over about 15-30 minutes.
Before the infusion, you will receive drugs to lower your risk of allergic reaction to the T cells. Tylenol® (acetaminophen) will be given by mouth and Benadryl® (diphenhydramine) may be given by mouth or by vein over a few minutes.
Your vital signs will be checked during and after the T cell infusion.
Study Tests after the T cell infusion:
Within 3 days, 1 week (+/- 2 days), 2 weeks (+/- 3 days), 1 month (+/- 7 days), 6 months (+/- 14 days), and 12 months (+/- 14 days) after the T-cell infusion, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any side effects that may have had.
- Blood (about 4 tablespoons) will be drawn for routine tests, tests to measure levels of certain proteins, and tests to look at your DNA to check the status of the disease. Part of this blood sample will be used to compare against a sample of blood that was collected before the gene transfer to check for HAMA (at 6 months after the T cell infusion only). At 1, 6, and 12 months after the T-cell infusions, part of this blood sample will be used to measure levels of certain proteins.
- Blood (about 4 tablespoons) will be drawn to learn how your body's immune system responds to the T-cell infusion.
At around 6 and 12 months after the T-cell infusion, if the study doctor thinks it is needed you will have CT scans, PET-CT scans, and/or a bone marrow biopsy to check the status of the disease.
Length of Study:
Your participation on this study will be over after you have completed the last planned study visit at about 12 months after the T cell infusion is complete. You may be taken off study early if the disease gets worse, you experience any intolerable side effects, you cannot keep your appointments, if your doctor thinks it is in your best interest, or if you are unable to receive the T-cell infusion.
If you leave the study early for any reason and you received T-cells, if possible, blood (about 2 teaspoons) will be collected. This blood sample will be used to compare against another sample of blood collected after the gene transfer is complete to check for HAMA.
Long-Term Follow-Up Study:
For safety reasons, the U.S. Food and Drug Administration (FDA) requires that patients who receive stem cells infusions that have been treated with a gene transfer procedure must have long-term follow-up for at least 15 years after receiving the gene transfer. You will be asked to sign a separate consent form for a long-term follow-up study Protocol 2006-0676.
This is an investigational study. Fludarabine and cyclophosphamide are commercially available and FDA approved for the treatment of CLL. The T cell infusion using a gene transfer procedure is not commercially available or FDA approved. At this time, T cell infusions using a gene transfer procedure is only being used in research.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Leukemia
- Being tested
- Leukapheresis, Fludarabine, Cyclophosphamide, T-cell Infusion
- Keywords
- Advanced Cancers, Leukemia, B-cell Chronic Lymphocytic Leukemia, B-CLL, CD19 positivity, CD19-specific T cells, T-Cell Infusion, Gene Transfer, Leukapheresis, Fludarabine, Fludarabine Phosphate, Fludara, Cyclophosphamide, Cytoxan, Neosar
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisProcedure or surgery
Blood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
25 mg/m2 by vein on Days -5 to Day -3.
CyclophosphamideDrug
Also called Cytoxan, Neosar
250 mg/kg by vein on Days -5 to -3.
T-cell InfusionProcedure or surgery
Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| T-Cell Infusion + Chemotherapy | Experimental | Peripheral blood mononuclear cells (PBMC) collected via venipuncture or steady state leukapheresis after enrollment. Clinically successful T-cell production defined as amount of T-cells required for dose level for which the patient is enrolled. Fludarabine 25 mg/m2 by vein on Days -5 to Day -3. Cyclophosphamide 250 mg/kg by vein on Days -5 to -3. Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0. Receives: Procedure: Leukapheresis; Drug: Fludarabine; Drug: Cyclophosphamide; Procedure: T-cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of CD19-specific T-cells
Maximum tolerated dose (MTD) defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Dose limiting toxicity (DLT) defined as new adverse events of grade 3+ (CTCAE version 4) involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal parameters occurring with 6 weeks of infusion that are probably or definitely related to T-cell product. The maximum acceptable toxicity rate is 25%.
Measured: 12 months
Secondary outcomes (1)
Clinically Successful T-Cell Production
Clinically successful T-cell production defined as the amount of T-cells required for the dose level for which the patient is enrolled.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study start11 Jun 2013
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653717
- Sponsor's protocol ID
- 2011-1169
- Other IDs
- NCI-2013-01084
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2012
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL)
- ClinicalTrials.gov ID
- NCT01653717
- Acronym / sponsor ID
- 2011-1169
- Conditions
- Advanced Cancers, Leukemia
- Keywords
- Advanced Cancers, Leukemia, B-cell Chronic Lymphocytic Leukemia, B-CLL, CD19 positivity, CD19-specific T cells, T-Cell Infusion, Gene Transfer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 31 Jul 2012 (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 goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied.
The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of genetically changed T cells, based on when you joined this study. Up to 4 dose levels of T cells will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose of than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T cells is found.
All participants will receive the same dose of chemotherapy.
T Cell Collection (leukapheresis or standard blood draw):
Within 30 days after you have completed the screening tests, you will have leukapheresis performed at the Apheresis Clinic at MD Anderson.
Before the leukapheresis:
- You will have a physical exam, including measurement of your height, weight, and vital signs.
- Your medical history will be recorded.
- Blood (about 4 tablespoons) will be drawn for routine tests and to measure levels of certain proteins.
A leukapheresis is a procedure used to remove blood from the body so that specific blood cells, such as T cells, can be collected. After the specific cells have been collected, the remaining blood is returned to the body.
To perform a leukapheresis, blood will be drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then the remaining blood will be returned back to you through a needle in a vein in the other arm. The procedure will take about 3 hours to complete.
If the doctor thinks it is in your best interest, instead of having a leukapheresis, blood (about 13.5 tablespoons) will be drawn to collect white blood cells instead.
If certain types of unwanted T cells are growing too much, an investigational device called a CliniMACS® system will be used to filter out the unwanted T cells using a magnet.
It will take about 7 weeks to modify and grow the necessary number of genetically modified T cells in the lab. If researchers are not able to collect enough T cells for your assigned dose level, you will be taken off study. Other options will be discussed with you by your doctor.
Chemotherapy:
Before you receive the T cell infusion, you will receive your standard chemotherapy with fludarabine and cyclophosphamide through a catheter (plastic tube) inserted into a large chest vein or through an intravenous needle (IV) inserted in a vein in your arm.
Fludarabine will be given by vein over 30 minutes daily for 3 days.
Cyclophosphamide will be given by vein over 3 hours daily for 3 days.
Study Tests Before the T cell Infusion:
Within 60 days before the T cell infusion:
- You will be asked about any side effects that you may have had.
- Blood (about 2 tablespoons) will be drawn for tests to look at your DNA to check the status of the disease. This may be performed any time before or during the study.
- Mouse protein antibodies are used in the gene transfer process. If your body becomes immune to these proteins, your body may develop antibodies against the mouse antibodies (called "human anti-mouse antibodies" or HAMA). Part of the blood sample will be used to compare against another sample of blood collected after the gene transfer is complete to check for HAMA.
- You will have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan to check your heart function.
- You will have lung function tests.
- If the study doctor thinks it is needed, you will have a bone marrow biopsy/aspiration to check the status of the disease. To collect a bone marrow biopsy/aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.
- If the study doctor thinks it is needed, you will have computed tomography (CT) scans and/or positron emission tomography (PET) scans to check the status of the disease.
Within 7 days before starting chemotherapy:
- You will have a physical exam, including measurement of your weight, and vital signs.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any side effects that you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests. Part of this blood sample will be used for a pregnancy test if you are able to become pregnant. To continue your participation in this study, you cannot be pregnant.
T-cell Infusion (gene transfer):
The T cell infusion will be given by vein over about 15-30 minutes.
Before the infusion, you will receive drugs to lower your risk of allergic reaction to the T cells. Tylenol® (acetaminophen) will be given by mouth and Benadryl® (diphenhydramine) may be given by mouth or by vein over a few minutes.
Your vital signs will be checked during and after the T cell infusion.
Study Tests after the T cell infusion:
Within 3 days, 1 week (+/- 2 days), 2 weeks (+/- 3 days), 1 month (+/- 7 days), 6 months (+/- 14 days), and 12 months (+/- 14 days) after the T-cell infusion, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your medical history will be reviewed and any updates will be recorded.
- You will be asked about any side effects that may have had.
- Blood (about 4 tablespoons) will be drawn for routine tests, tests to measure levels of certain proteins, and tests to look at your DNA to check the status of the disease. Part of this blood sample will be used to compare against a sample of blood that was collected before the gene transfer to check for HAMA (at 6 months after the T cell infusion only). At 1, 6, and 12 months after the T-cell infusions, part of this blood sample will be used to measure levels of certain proteins.
- Blood (about 4 tablespoons) will be drawn to learn how your body's immune system responds to the T-cell infusion.
At around 6 and 12 months after the T-cell infusion, if the study doctor thinks it is needed you will have CT scans, PET-CT scans, and/or a bone marrow biopsy to check the status of the disease.
Length of Study:
Your participation on this study will be over after you have completed the last planned study visit at about 12 months after the T cell infusion is complete. You may be taken off study early if the disease gets worse, you experience any intolerable side effects, you cannot keep your appointments, if your doctor thinks it is in your best interest, or if you are unable to receive the T-cell infusion.
If you leave the study early for any reason and you received T-cells, if possible, blood (about 2 teaspoons) will be collected. This blood sample will be used to compare against another sample of blood collected after the gene transfer is complete to check for HAMA.
Long-Term Follow-Up Study:
For safety reasons, the U.S. Food and Drug Administration (FDA) requires that patients who receive stem cells infusions that have been treated with a gene transfer procedure must have long-term follow-up for at least 15 years after receiving the gene transfer. You will be asked to sign a separate consent form for a long-term follow-up study Protocol 2006-0676.
This is an investigational study. Fludarabine and cyclophosphamide are commercially available and FDA approved for the treatment of CLL. The T cell infusion using a gene transfer procedure is not commercially available or FDA approved. At this time, T cell infusions using a gene transfer procedure is only being used in research.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-Cell Infusion + Chemotherapy | Experimental | Procedure: Leukapheresis, Drug: Fludarabine, Drug: Cyclophosphamide, Procedure: T-cell InfusionPeripheral blood mononuclear cells (PBMC) collected via venipuncture or steady state leukapheresis after enrollment. Clinically successful T-cell production defined as amount of T-cells required for dose level for which the patient is enrolled. Fludarabine 25 mg/m2 by vein on Days -5 to Day -3. Cyclophosphamide 250 mg/kg by vein on Days -5 to -3. Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a history of B-CLL, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
- Confirmed history of CD19 positivity by flow cytometry.
- At least 8 weeks from last cytotoxic chemotherapy. Patients may continue ibrutinib or lenalidomide. These drugs will be discontinued 1 week prior to start of lymphodepleting chemotherapy.
- Karnofsky Performance Scale > 60%.
- Absolute lymphocyte count >100/uL.
Key exclusion criteria (6 listed)
- Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
- Presence of autoimmune phenomenon (AIHA, ITP) requiring steroid therapy.
- Presence of Grade 3 or greater toxicity from the previous treatment.
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 |
|---|---|---|
| LeukapheresisBlood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete. | Procedure or surgery | T-Cell Infusion + Chemotherapy |
| FludarabineAlso: Fludarabine Phosphate, Fludara25 mg/m2 by vein on Days -5 to Day -3. | Drug | T-Cell Infusion + Chemotherapy |
| CyclophosphamideAlso: Cytoxan, Neosar250 mg/kg by vein on Days -5 to -3. | Drug | T-Cell Infusion + Chemotherapy |
| T-cell InfusionBeginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0. | Procedure or surgery | T-Cell Infusion + Chemotherapy |
Primary outcome
Maximum Tolerated Dose (MTD) of CD19-specific T-cells
Time frame: 12 months
Maximum tolerated dose (MTD) defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Dose limiting toxicity (DLT) defined as new adverse events of grade 3+ (CTCAE version 4) involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal parameters occurring with 6 weeks of infusion that are probably or definitely related to T-cell product. The maximum acceptable toxicity rate is 25%.
1 secondary outcome
Clinically Successful T-Cell Production
Time frame: 7 weeks
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 17 Aug 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Chitra M. Hosing, MD principal investigator
M.D. Anderson Cancer 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 Leukapheresis, Fludarabine and Cyclophosphamide in people with Advanced Cancers and Leukemia, run by M.D. Anderson Cancer 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 9 inclusion and 6 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 17 Aug 2017. 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?
Maximum Tolerated Dose (MTD) of CD19-specific T-cells (time frame: 12 months). 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 17 Aug 2017.