Blood And Marrow TransplantationPhase 1NCT02274506
Infusion of Allogeneic, 3rd Party CD19-specific T Cells
A Phase 1 study testing Cyclophosphamide, Fludarabine and T-Cell Infusion in people with Blood And Marrow Transplantation and Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if researchers can successfully and safely give patients who have had a stem cell transplant an infusion of white blood cells (called T-cells) that have been collected from an unrelated person, and that have been genetically changed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blood And Marrow Transplantation, Leukemia, Lymphoma
- What is being tested?
- Cyclophosphamide, Fludarabine and T-Cell Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2014to 20 Oct 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of refractory B-cell lymphoid malignancies: 1) acute lymphoblastic leukemia (ALL), CD19+, 2) biphenotypic leukemia CD19+, 3) non-Hodgkin's Lymphoma (NHL), which includes diffuse large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia (CLL).
- Age 18 to 70 years.
- Zubrod performance 0-2 or Karnofsky greater than or equal to 60%.
- Patient or patient's legal representative able to provide written informed consent.
- Patient or patient's legal representative able to provide written informed consent for the long-term follow-up gene therapy study.
- Patients must be a minimum of 3 months from last hematopoietic stem cell transplant (HSCT) and 3 weeks from last systemic chemotherapy.
Who cannot join
- Patients with known allergy to bovine or murine products.
- Clinically significant acute or chronic GVHD requiring systemic immunosuppression, including methylprednisolone >/= 1 mg/kg/day.
- Systemic corticosteroid use within 72 hours of treatment initiation.
- Antibody to HLA expressed on 3rd party T cells.
- Experiencing any new Grade >2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to treatment initiation.
- Active infection defined as positive culture, if available, for bacteria, fungus, or virus within a 3-day period prior to treatment initiation and/or fever greater than 38°C within 24 hours prior to treatment initiation.
- Positive beta HCG by qualitative pregnancy test in female of child-bearing potential defined as not post menopausal for 12 months or absence of previous surgical sterilization.
About this study
Official title: Infusion of Allogeneic, 3rd Party CD19-specific T Cells for Patients With Refractory CD19+ B-Lineage Lymphoid Malignancies
The goal of this clinical research study is to learn if researchers can successfully and safely give patients who have had a stem cell transplant an infusion of white blood cells (called T-cells) that have been collected from an unrelated person, and that have been genetically changed. The process of changing the DNA (genetic material) of these T-cells is called "gene transfer." The gene transfer involves drawing blood from an unrelated donor, separating out T cells using a machine, changing the cells' DNA in the laboratory, and returning the genetically changed cells back to the body. T-cells are a type of white blood cell that fight infection. The type of gene transfer being used in this study is designed to help your T-cells to better fight cancer by targeting a chemical marker that is found on certain cancer cells.
Researchers want to learn if these genetically-changed T-cells can help to control B-cell leukemia or lymphoma after a stem cell transplant.
Researchers want to find out the highest tolerable dose of these T-cells that can be given to patients with relapsed leukemia or lymphoma.
Read the detailed description
Study Plan:
This study has 2 steps: chemotherapy and gene transfer.
The chemotherapy combination in this study (fludarabine and cyclophosphamide) is given to try to help the T-cells work better.
Study Groups:
If the participant is found to be eligible to take part in this study, the participant will be assigned to a dose level of T-cells based on when the participant joined this study. The first group of 3 participants will receive the lowest dose of T-cells. Each new group will receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested.
Chemotherapy and Gene Transfer:
- On Day -8 (8 days before the T-cell infusion) and Day -7, the participant will receive cyclophosphamide by vein over about 4 hours. the participant will receive mesna by vein over 30 minutes every 4 hours to lower the risk of bleeding in the bladder.
- On Day -6 through Day -2, the participant will receive fludarabine 1 time a day by vein over about 30 minutes.
Sometime between 2-7 days after chemotherapy ends, the participant will receive the T cell infusion by vein over 15-30 minutes. The infusion will be divided into 2 parts at least 24 hours apart. During and after the infusion, your vital signs will be checked.
the participant will be given standard drugs to help decrease the risk of side effects. the participant may ask the study staff for information about how the drugs are given and their risks.
If the doctor thinks it is needed based on the status of the disease, the participant may receive up to 2 more courses of this study therapy given at least 6 weeks apart.
Study Tests:
the participant will be in the hospital from Day -8 through 2 days after the stem cell transplant. Every day while you are in the hospital, blood (about 2 teaspoons) will be drawn for routine tests.
About 1 week before the T-cell infusion, the following tests and procedures will be performed. These tests will not be repeated again if the T-cell infusion is repeated.
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- Blood (about 4 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test if the participant is able to become pregnant.
- Part of the blood drawn for routine tests will also be used to test for antibodies the participant may develop against the mouse antibodies that are used in the gene transfer process. These antibodies are called human anti-mouse antibodies (HAMA). If your body becomes immune to these proteins, the participant may develop HAMA. The results of this HAMA test will be used to compare against a sample of your blood collected after the transplant is complete, to make sure the participant have not developed an immune system reaction against these mouse protein antibodies.
- the participant will have a chest x-ray to check for pneumonia.
- the participant will have an ECG to check your heart function.
Before the T-cell infusion and up to 2 times within 24 hours after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Follow-Up:
Within about 12 hours, 3 days, 1 week, and 2 weeks after the T-cell infusion, the following tests and procedures will be performed. These tests will be repeated again if the T-cell infusion is repeated.
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- During the physical exam, you will be checked for possible reactions to the study therapy, such as graft versus host disease (GVHD). GVHD occurs when the donor cells attack the cells of the recipient's body.
- the participant will be asked about any side effects you may have had.
- Blood (about 4 tablespoons) will be drawn for routine tests and for research to look for the genetically changed T-cells and to count the number of B-cells (other white blood cells) and other non-changed T-cells.
Up to 3 times during the first 7 days after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Every 2 weeks during the first month, then 1 time a month until 1 year after the T-cell infusion, blood (2 teaspoons) will be drawn for tests of your immune system.
At about 6 weeks, and then 1, 2, and 3 months after the T-cell infusion:
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- the participant will be checked for possible reactions to the study therapy, such as GVHD.
- the participant will be asked about any side effects you may have had.
At about 3 months after the T-cell infusion, blood (about 2 teaspoons) will be drawn to check for HAMA, and you will have breathing tests to check your lung function.
At least 1 time during the 3 months after the T-cell infusion:
- the participant will have a PET-CT scan and/or a CT scan to check the status of the disease.
- If the doctor thinks it is needed, you will have other tests and procedures to check your health, such as a bone marrow aspiration and biopsy.
If the disease comes back or a side effect occurs during the 12 months after the T-cell infusion, you may be asked to return for additional follow-up visits if the doctor thinks it is needed.
Length of Study:
the participant may receive up to 3 courses of study therapy. the participant will no longer be able to receive the study therapy if the disease gets worse, if infections or intolerable side effects occur, or if the participant is unable to follow study directions. the participant may withdraw from the study at any time, but the infusion of the T cells is not necessarily reversible and these types of products have the potential for long-term survival in the body. If the participant withdraw from the study it will only include withdrawal from any procedures specifically preformed for this protocol and long-term follow-up. Please note, long-term follow-up is important for your safety.
Your participation on the study will be over once the participant have completed the follow-up visits.
Long-Term Follow-Up:
For safety reasons, the FDA requires patients receiving gene transfer to have long-term follow-up for at least 15 years after receiving the gene transfer. The participant will be asked to sign a separate consent form (Protocol 2006-0676) for long-term follow up that begins 1 year after this study ends.
This is an investigational study. The chemotherapy drugs in this study are commercially available and FDA approved for the treatment of B-cell leukemia or lymphoma. The gene transfer (infusion with genetically modified T-cells) is not commercially available or FDA approved. It is currently being used for research purposes only.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Blood And Marrow Transplantation, Leukemia, Lymphoma
- Being tested
- Cyclophosphamide, Fludarabine, T-Cell Infusion
- Keywords
- Blood And Marrow Transplantation, Leukemia, Lymphoma, CD19-specific T cells, Acute lymphoblastic leukemia, ALL, Biphenotypic leukemia, Non-Hodgkin's Lymphoma, NHL, Diffuse large B-cell lymphoma, Small lymphocytic lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukemia, CLL
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Neosar
60 mg/kg by vein on Days -8 and -7.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
25 mg/m2 by vein on Days -6 to -2.
T-Cell InfusionProcedure or surgery
T-cells infused no sooner than 48 hours and no later than 1 week post completion of chemotherapy on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| T-Cell Administration | Experimental | Cyclophosphamide 60 mg/kg by vein for 2 consecutive days, followed by Fludarabine at 25 mg/m2/day by vein for 5 consecutive days. Fludarabine dose calculated per adjusted ideal body weight.
T-cell product divided into 2 portions. Up to 25% of the genetically modified cells given on first day, with plan to infuse up to 75% of the remaining T-cell dose no sooner than 24 hours after completion of first portion. Second portion should not be given later than 72 hours after first portion. First group of 3 participants receive lowest dose of T-cells. Each new group receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; 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) is highest dose level 6 patients treated, with at most 2 experiencing dose limiting toxicity (DLT). DLT defined as new adverse event attributable to CD19-specific T cells of grade >3 that lasts for more than 3 days, and related to CD19-specific T cells within 30 days of an infusion. Grade 3/4 graft versus host disease (GVHD) occurring within 6 weeks of CD19-specific T cells administration, also a DLT. Graft failure following CD19-specific T cells administration considered DLT.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start20 Oct 2014
- Primary completion20 Oct 2014
- Study completion20 Oct 2014
Why it stopped: PI's response to ePAAC, has withdrawn the protocol acknowledging the PI's action.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood And Marrow TransplantationStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Partow Kebriaei, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274506
- Sponsor's protocol ID
- 2011-0235
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2014
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Allogeneic, 3rd Party CD19-specific T Cells for Patients With Refractory CD19+ B-Lineage Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT02274506
- Acronym / sponsor ID
- 2011-0235
- Conditions
- Blood And Marrow Transplantation, Leukemia, Lymphoma
- Keywords
- Blood And Marrow Transplantation, Leukemia, Lymphoma, CD19-specific T cells, Acute lymphoblastic leukemia, ALL, Biphenotypic leukemia, Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI's response to ePAAC, has withdrawn the protocol acknowledging the PI's action.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 20 Oct 2014 (actual)
- Study completion
- 20 Oct 2014 (actual)
- First posted
- 24 Oct 2014 (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 learn if researchers can successfully and safely give patients who have had a stem cell transplant an infusion of white blood cells (called T-cells) that have been collected from an unrelated person, and that have been genetically changed. The process of changing the DNA (genetic material) of these T-cells is called "gene transfer." The gene transfer involves drawing blood from an unrelated donor, separating out T cells using a machine, changing the cells' DNA in the laboratory, and returning the genetically changed cells back to the body. T-cells are a type of white blood cell that fight infection. The type of gene transfer being used in this study is designed to help your T-cells to better fight cancer by targeting a chemical marker that is found on certain cancer cells.
Researchers want to learn if these genetically-changed T-cells can help to control B-cell leukemia or lymphoma after a stem cell transplant.
Researchers want to find out the highest tolerable dose of these T-cells that can be given to patients with relapsed leukemia or lymphoma.
Detailed description
Study Plan:
This study has 2 steps: chemotherapy and gene transfer.
The chemotherapy combination in this study (fludarabine and cyclophosphamide) is given to try to help the T-cells work better.
Study Groups:
If the participant is found to be eligible to take part in this study, the participant will be assigned to a dose level of T-cells based on when the participant joined this study. The first group of 3 participants will receive the lowest dose of T-cells. Each new group will receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested.
Chemotherapy and Gene Transfer:
- On Day -8 (8 days before the T-cell infusion) and Day -7, the participant will receive cyclophosphamide by vein over about 4 hours. the participant will receive mesna by vein over 30 minutes every 4 hours to lower the risk of bleeding in the bladder.
- On Day -6 through Day -2, the participant will receive fludarabine 1 time a day by vein over about 30 minutes.
Sometime between 2-7 days after chemotherapy ends, the participant will receive the T cell infusion by vein over 15-30 minutes. The infusion will be divided into 2 parts at least 24 hours apart. During and after the infusion, your vital signs will be checked.
the participant will be given standard drugs to help decrease the risk of side effects. the participant may ask the study staff for information about how the drugs are given and their risks.
If the doctor thinks it is needed based on the status of the disease, the participant may receive up to 2 more courses of this study therapy given at least 6 weeks apart.
Study Tests:
the participant will be in the hospital from Day -8 through 2 days after the stem cell transplant. Every day while you are in the hospital, blood (about 2 teaspoons) will be drawn for routine tests.
About 1 week before the T-cell infusion, the following tests and procedures will be performed. These tests will not be repeated again if the T-cell infusion is repeated.
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- Blood (about 4 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test if the participant is able to become pregnant.
- Part of the blood drawn for routine tests will also be used to test for antibodies the participant may develop against the mouse antibodies that are used in the gene transfer process. These antibodies are called human anti-mouse antibodies (HAMA). If your body becomes immune to these proteins, the participant may develop HAMA. The results of this HAMA test will be used to compare against a sample of your blood collected after the transplant is complete, to make sure the participant have not developed an immune system reaction against these mouse protein antibodies.
- the participant will have a chest x-ray to check for pneumonia.
- the participant will have an ECG to check your heart function.
Before the T-cell infusion and up to 2 times within 24 hours after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Follow-Up:
Within about 12 hours, 3 days, 1 week, and 2 weeks after the T-cell infusion, the following tests and procedures will be performed. These tests will be repeated again if the T-cell infusion is repeated.
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- During the physical exam, you will be checked for possible reactions to the study therapy, such as graft versus host disease (GVHD). GVHD occurs when the donor cells attack the cells of the recipient's body.
- the participant will be asked about any side effects you may have had.
- Blood (about 4 tablespoons) will be drawn for routine tests and for research to look for the genetically changed T-cells and to count the number of B-cells (other white blood cells) and other non-changed T-cells.
Up to 3 times during the first 7 days after the T-cell infusion, blood (about 4 tablespoons) will be drawn to measure your body's response to the T cell infusion.
Every 2 weeks during the first month, then 1 time a month until 1 year after the T-cell infusion, blood (2 teaspoons) will be drawn for tests of your immune system.
At about 6 weeks, and then 1, 2, and 3 months after the T-cell infusion:
- the participant's medical history will be recorded.
- the participant will have a physical exam, including measurement of your vital signs.
- the participant will be checked for possible reactions to the study therapy, such as GVHD.
- the participant will be asked about any side effects you may have had.
At about 3 months after the T-cell infusion, blood (about 2 teaspoons) will be drawn to check for HAMA, and you will have breathing tests to check your lung function.
At least 1 time during the 3 months after the T-cell infusion:
- the participant will have a PET-CT scan and/or a CT scan to check the status of the disease.
- If the doctor thinks it is needed, you will have other tests and procedures to check your health, such as a bone marrow aspiration and biopsy.
If the disease comes back or a side effect occurs during the 12 months after the T-cell infusion, you may be asked to return for additional follow-up visits if the doctor thinks it is needed.
Length of Study:
the participant may receive up to 3 courses of study therapy. the participant will no longer be able to receive the study therapy if the disease gets worse, if infections or intolerable side effects occur, or if the participant is unable to follow study directions. the participant may withdraw from the study at any time, but the infusion of the T cells is not necessarily reversible and these types of products have the potential for long-term survival in the body. If the participant withdraw from the study it will only include withdrawal from any procedures specifically preformed for this protocol and long-term follow-up. Please note, long-term follow-up is important for your safety.
Your participation on the study will be over once the participant have completed the follow-up visits.
Long-Term Follow-Up:
For safety reasons, the FDA requires patients receiving gene transfer to have long-term follow-up for at least 15 years after receiving the gene transfer. The participant will be asked to sign a separate consent form (Protocol 2006-0676) for long-term follow up that begins 1 year after this study ends.
This is an investigational study. The chemotherapy drugs in this study are commercially available and FDA approved for the treatment of B-cell leukemia or lymphoma. The gene transfer (infusion with genetically modified T-cells) is not commercially available or FDA approved. It is currently being used for research purposes only.
Up to 42 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 Administration | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Procedure: T-Cell InfusionCyclophosphamide 60 mg/kg by vein for 2 consecutive days, followed by Fludarabine at 25 mg/m2/day by vein for 5 consecutive days. Fludarabine dose calculated per adjusted ideal body weight. T-cell product divided into 2 portions. Up to 25% of the genetically modified cells given on first day, with plan to infuse up to 75% of the remaining T-cell dose no sooner than 24 hours after completion of first portion. Second portion should not be given later than 72 hours after first portion. First group of 3 participants receive lowest dose of T-cells. Each new group receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a history of refractory B-cell lymphoid malignancies: 1) acute lymphoblastic leukemia (ALL), CD19+, 2) biphenotypic leukemia CD19+, 3) non-Hodgkin's Lymphoma (NHL), which includes diffuse large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia (CLL).
- Age 18 to 70 years.
- Zubrod performance 0-2 or Karnofsky greater than or equal to 60%.
- Patient or patient's legal representative able to provide written informed consent.
- Patient or patient's legal representative able to provide written informed consent for the long-term follow-up gene therapy study.
Key exclusion criteria (7 listed)
- Patients with known allergy to bovine or murine products.
- Clinically significant acute or chronic GVHD requiring systemic immunosuppression, including methylprednisolone >/= 1 mg/kg/day.
- Systemic corticosteroid use within 72 hours of treatment initiation.
- Antibody to HLA expressed on 3rd party T cells.
- Experiencing any new Grade >2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to treatment initiation.
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 |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, Neosar60 mg/kg by vein on Days -8 and -7. | Drug | T-Cell Administration |
| FludarabineAlso: Fludarabine Phosphate, Fludara25 mg/m2 by vein on Days -6 to -2. | Drug | T-Cell Administration |
| T-Cell InfusionT-cells infused no sooner than 48 hours and no later than 1 week post completion of chemotherapy on Day 0. | Procedure or surgery | T-Cell Administration |
Primary outcome
Maximum Tolerated Dose (MTD) of CD19-Specific T Cells
Time frame: 12 hours
Maximum tolerated dose (MTD) is highest dose level 6 patients treated, with at most 2 experiencing dose limiting toxicity (DLT). DLT defined as new adverse event attributable to CD19-specific T cells of grade >3 that lasts for more than 3 days, and related to CD19-specific T cells within 30 days of an infusion. Grade 3/4 graft versus host disease (GVHD) occurring within 6 weeks of CD19-specific T cells administration, also a DLT. Graft failure following CD19-specific T cells administration considered DLT.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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.
Partow Kebriaei, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and T-Cell Infusion in people with Blood And Marrow Transplantation and Leukemia, run by M.D. Anderson Cancer Center.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 hours). 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 22 Jan 2020.