Acute Lymphoblastic LeukemiaPhase 1CASPALLONCT00710892
CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene
A Phase 1 study testing Allodepleted T Cells in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome
- What is being tested?
- Allodepleted T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At the time of transplant:
- Patients (up to 65 years of age) with:
- ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease.
- Myelodysplastic syndrome.
- AML after first relapse or with primary refractory disease.
- CML
Show all 17Show fewer
- Hemophagocytic lymphohistiocytosis (HLH); familial hemophagocytic lymphohistiocytosis (FLH); viral-associated hemophagocytic syndrome (VAHS); patients with severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T or NK cell malignancy; X-linked lymphoproliferative disease (XLP)
- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
- At the time of allodepleted T cell infusion:
- Engrafted with ANC greater than 500.
- Must have greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
- Life expectancy greater than 30 days
- Lansky/Karnofsky scores greater than or equal to 60
- Absence of severe renal disease (creatinine greater than 2X normal for age)
- Absence of severe hepatic disease (direct bilirubin greater than 2 mg/dL, or SGOT greater than 200
- Oxygen saturation greater than 94% on room air
- Patient/Guardian able to give informed consent
Who cannot join
- At the time of transplant:
- 1. Pregnancy
- At the time of allodepleted T cell infusion:
- GvHD
- Severe intercurrent infection
- Pregnancy*
- Other investigational drugs in the prior 30 days
- Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.
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: CASPALLO: A Phase I Study Evaluating the Use of Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene After Haploidentical Stem Cell Transplantation
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Stem cells are created in the bone marrow. They grow into different types of blood cells that we need, including red blood cells, white blood cells, and platelets.
We have identified a close relative of the patients whose stem cells are not a perfect match for the patient, but can be used. This type of transplant is called "allogeneic", meaning that the cells come from a donor. With this type of donor who is not a perfect match, there is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer delay in the recovery of the immune system.
Read more
GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when the new donor cells recognize that the body tissues of the patient are different from those of the donor.
In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we insert it using a virus called a retrovirus that has been made for this study. The drug (AP1903) that will be used to "activate" the iCasp9 is an experimental drug that has been tested in a study in normal donors, with no bad side effects. We hope we can use this drug to kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies. However we do not yet know whether AP1903 will kill T cells in humans, even though it has worked in our experimental studies on human cells in animals. Nor do we know whether killing the T cells will help the GvHD. Because of this uncertainty, patients who develop significant GvHD will also receive standard therapy for this complication, in addition to the experimental drug. We hope that having this safety switch in the T cells will let us give higher doses of T cells that will make the immune system recover faster. These specially treated "suicide gene" T cells are an investigational product not approved by the Food and Drug Administration.
Read the detailed description
Because the patient will receive cells with a new gene in them, they will be followed for a total of 15 years to see if there are any long-term side effects of the gene transfer.
Before the conditioning treatment for the transplant, we collected 30 mL (6 teaspoonfuls) of blood from the patient, which we made into a cell line that grows in the laboratory by mixing the blood with a virus called EBV. Some of the cells from this blood were mixed with T cells from the blood stem cell donor, to stimulate cells that might cause GvHD. We then added an investigational agent called RFT5-dgA. The RFT5-dgA helped to get rid of donor T cells that might cause GvHD. To get iCasp9 into the remaining T cells, we have to insert the iCasp9 gene into these cells. This is done with a virus called a retrovirus that has been made for this study, and will carry the iCasp9 gene into the T cells. The virus also has another gene called CD19, which will make the cells express the CD19 protein on their surface. We will not inject the virus directly into the patient, but only into the special T cells we have made in the laboratory. After we have put the virus into the cells, we will select the T cells that have CD19 on their surface, so we know these cells will also have the iCasp9 gene. We will perform tests on the specially treated cells before giving them to the patient, to ensure they only carry the iCasp9 gene, and not the virus itself. This should ensure that no virus can come out of the cells and infect other cells in the body.
TREATMENT PLAN:
To prepare the body for transplantation, the patient will be given high-dose chemotherapy. Further discussion of the treatment plan for the stem cell transplant will be discussed with the patient separately, and they will sign a separate consent form.
If the patient is doing well after the transplant, and they do not have serious GvHD, they will be eligible to receive the special T cells from Day 30 to 90 post-transplant. The specially selected and treated T cells will be given by vein, once. The cells will be given between Day 30 and day 90 after the patient receives their stem cell transplant. We will give special medicines before the IV starts to help prevent allergic reactions that might occur. Because there is a possibility that the specially treated T cells can cause or worsen GvHD, we will not be able to give these cells if the patient already has significant GvHD.
If the patient develops GvHD after being given the specially treated T cells, we will prescribe the new drug that has been shown to kill cells carrying iCasp9. The drug's name is AP1903. It has been tested in normal healthy volunteers, and has not caused any bad effects, but it is not approved by the FDA. Although the drug is not approved by the FDA, the FDA has allowed us to use the drug for this study. This drug will be given as a 2-hour intravenous infusion. We will take 10 mL (2 teaspoonfuls) of blood on days 2, 4, 7 and 14 after the infusion to check if the drug has been successful in killing the specially treated cells. If the patient has mild GvHD, and if the GvHD does not get better with AP1903, we will give the patient additional medicines that are usually used to treat GvHD. If the patient has serious GvHD, we will immediately give additional medicines that are usually used to treat GvHD, as well as AP1903. In some cases though, GvHD does not respond to treatments.
- Conditions
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome, Chronic Myeloid Leukemia
- Being tested
- Allodepleted T Cells
- Keywords
- suicide gene-modified allodepleted donor lymphocytes, given to recipients of haploidentical stem cell transplants, Stage III, Stage IV, Myelodysplastic syndrome, AML after first relapse, primary refractory disease, CML, Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), Severe chronic active Epstein Barr virus infection (SCAEBV), T or NK cell malignancy, X-linked lymphoproliferative disease (XLP)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphohistiocytosis, Hemophagocytic, Histiocytic Sarcoma, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allodepleted T CellsBiological
Dose Level 1 = 1 x 10e6 T cells/kg; Dose Level 2 = 3 x 10e6 T cells/kg; Dose Level 3 = 1 x 10e7 T cells/kg.
Patients may be enrolled at the next dose level of T cells when all patients at the previous dose level have reached Day 42 post-T cell infusion without unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1-3 | Experimental | Administration of suicide gene-modified allodepleted T cells. Receives: Biological: Allodepleted T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum number of suicide gene-modified allodepleted donor lymphocytes that can be given to recipients of haploidentical stem cell transplants that will result in a rate of Grade III/IV GVHD of 25% or less.
Maximum tolerated dose of suicide gene-modified allodepleted donor lymphocytes up to a total of 1 x 10e7/kg per dose.
Measured: 45 days
Secondary outcomes (4)
To evaluate the biological effects of administration of AP1903, a dimerizer used to activate the suicide gene mechanism, and its clinical effects in patients who develop GvHD.
To assess the biological effects (i.e. on numbers of transduced peripheral blood T cells) of AP1903 in patients who develop Grade ≥ I GvHD.
Measured: 1 year
To analyze the contribution of the gene-modified cells to immune reconstitution in these patients by measuring their survival, persistence and expansion.
Investigators will analyze several parameters (Immunophenotyping, T and B cell function) measuring immune reconstitution resulting from iCaspase transduced allodepleted T cells.
Measured: 15 years
To measure the overall and disease-free survival at 100 days and at 1 year post-transplant.
Investigators will measure patients' overall and disease free survival, at 100 days and at 1 year post transplant.
Measured: 1 year
To obtain preliminary information on whether subjects receiving additional doses of cells show a cumulative rise in the percentage of circulating gene-modified cells.
Preliminary information will be obtained on whether patients who receive additional injections of the T cells show a rise in the percentage of circulating gene modified cells.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2011
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Malcolm Brenner, Baylor College of Medicine
- Investigators
- Malcolm K Brenner, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710892
- Sponsor's protocol ID
- 21580-CASPALLO
- Acronym
- CASPALLO
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2008
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chang EC, Liu H, West JA, Zhou X, Dakhova O, Wheeler DA, Heslop HE, Brenner MK, Dotti G. Clonal Dynamics In Vivo of Virus Integration Sites of T Cells Expressing a Safety Switch. Mol Ther. 2016 Apr;24(4):736-45. doi: 10.1038/mt.2015.217. Epub 2015 Dec 7.
PubMed 26639404Zhou X, Di Stasi A, Brenner MK. iCaspase 9 Suicide Gene System. Methods Mol Biol. 2015;1317:87-105. doi: 10.1007/978-1-4939-2727-2_6.
PubMed 26072403Zhou X, Di Stasi A, Tey SK, Krance RA, Martinez C, Leung KS, Durett AG, Wu MF, Liu H, Leen AM, Savoldo B, Lin YF, Grilley BJ, Gee AP, Spencer DM, Rooney CM, Heslop HE, Brenner MK, Dotti G. Long-term outcome after haploidentical stem cell transplant and infusion of T cells expressing the inducible caspase 9 safety transgene. Blood. 2014 Jun 19;123(25):3895-905. doi: 10.1182/blood-2014-01-551671. Epub 2014 Apr 21.
PubMed 24753538Di Stasi A, Tey SK, Dotti G, Fujita Y, Kennedy-Nasser A, Martinez C, Straathof K, Liu E, Durett AG, Grilley B, Liu H, Cruz CR, Savoldo B, Gee AP, Schindler J, Krance RA, Heslop HE, Spencer DM, Rooney CM, Brenner MK. Inducible apoptosis as a safety switch for adoptive cell therapy. N Engl J Med. 2011 Nov 3;365(18):1673-83. doi: 10.1056/NEJMoa1106152.
PubMed 22047558
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASPALLO: A Phase I Study Evaluating the Use of Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene After Haploidentical Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00710892
- Acronym / sponsor ID
- CASPALLO / 21580-CASPALLO
- Conditions
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome, Chronic Myeloid Leukemia
- Keywords
- suicide gene-modified allodepleted donor lymphocytes, given to recipients of haploidentical stem cell transplants, Stage III, Stage IV, Myelodysplastic syndrome, AML after first relapse, primary refractory disease, CML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Dec 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Jul 2008 (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.
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Stem cells are created in the bone marrow. They grow into different types of blood cells that we need, including red blood cells, white blood cells, and platelets.
We have identified a close relative of the patients whose stem cells are not a perfect match for the patient, but can be used. This type of transplant is called "allogeneic", meaning that the cells come from a donor. With this type of donor who is not a perfect match, there is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer delay in the recovery of the immune system.
GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when the new donor cells recognize that the body tissues of the patient are different from those of the donor.
In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we insert it using a virus called a retrovirus that has been made for this study. The drug (AP1903) that will be used to "activate" the iCasp9 is an experimental drug that has been tested in a study in normal donors, with no bad side effects. We hope we can use this drug to kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies. However we do not yet know whether AP1903 will kill T cells in humans, even though it has worked in our experimental studies on human cells in animals. Nor do we know whether killing the T cells will help the GvHD. Because of this uncertainty, patients who develop significant GvHD will also receive standard therapy for this complication, in addition to the experimental drug. We hope that having this safety switch in the T cells will let us give higher doses of T cells that will make the immune system recover faster. These specially treated "suicide gene" T cells are an investigational product not approved by the Food and Drug Administration.
Detailed description
Because the patient will receive cells with a new gene in them, they will be followed for a total of 15 years to see if there are any long-term side effects of the gene transfer.
Before the conditioning treatment for the transplant, we collected 30 mL (6 teaspoonfuls) of blood from the patient, which we made into a cell line that grows in the laboratory by mixing the blood with a virus called EBV. Some of the cells from this blood were mixed with T cells from the blood stem cell donor, to stimulate cells that might cause GvHD. We then added an investigational agent called RFT5-dgA. The RFT5-dgA helped to get rid of donor T cells that might cause GvHD. To get iCasp9 into the remaining T cells, we have to insert the iCasp9 gene into these cells. This is done with a virus called a retrovirus that has been made for this study, and will carry the iCasp9 gene into the T cells. The virus also has another gene called CD19, which will make the cells express the CD19 protein on their surface. We will not inject the virus directly into the patient, but only into the special T cells we have made in the laboratory. After we have put the virus into the cells, we will select the T cells that have CD19 on their surface, so we know these cells will also have the iCasp9 gene. We will perform tests on the specially treated cells before giving them to the patient, to ensure they only carry the iCasp9 gene, and not the virus itself. This should ensure that no virus can come out of the cells and infect other cells in the body.
TREATMENT PLAN:
To prepare the body for transplantation, the patient will be given high-dose chemotherapy. Further discussion of the treatment plan for the stem cell transplant will be discussed with the patient separately, and they will sign a separate consent form.
If the patient is doing well after the transplant, and they do not have serious GvHD, they will be eligible to receive the special T cells from Day 30 to 90 post-transplant. The specially selected and treated T cells will be given by vein, once. The cells will be given between Day 30 and day 90 after the patient receives their stem cell transplant. We will give special medicines before the IV starts to help prevent allergic reactions that might occur. Because there is a possibility that the specially treated T cells can cause or worsen GvHD, we will not be able to give these cells if the patient already has significant GvHD.
If the patient develops GvHD after being given the specially treated T cells, we will prescribe the new drug that has been shown to kill cells carrying iCasp9. The drug's name is AP1903. It has been tested in normal healthy volunteers, and has not caused any bad effects, but it is not approved by the FDA. Although the drug is not approved by the FDA, the FDA has allowed us to use the drug for this study. This drug will be given as a 2-hour intravenous infusion. We will take 10 mL (2 teaspoonfuls) of blood on days 2, 4, 7 and 14 after the infusion to check if the drug has been successful in killing the specially treated cells. If the patient has mild GvHD, and if the GvHD does not get better with AP1903, we will give the patient additional medicines that are usually used to treat GvHD. If the patient has serious GvHD, we will immediately give additional medicines that are usually used to treat GvHD, as well as AP1903. In some cases though, GvHD does not respond to treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1-3 | Experimental | Biological: Allodepleted T CellsAdministration of suicide gene-modified allodepleted T cells. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Patients (up to 65 years of age) with:
- ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease.
- Myelodysplastic syndrome.
- AML after first relapse or with primary refractory disease.
- CML
Key exclusion criteria (8 listed)
- 1. Pregnancy
- GvHD
- Severe intercurrent infection
- Pregnancy*
- Other investigational drugs in the prior 30 days
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 |
|---|---|---|
| Allodepleted T CellsDose Level 1 = 1 x 10e6 T cells/kg; Dose Level 2 = 3 x 10e6 T cells/kg; Dose Level 3 = 1 x 10e7 T cells/kg. Patients may be enrolled at the next dose level of T cells when all patients at the previous dose level have reached Day 42 post-T cell infusion without unacceptable toxicity. | Biological | Dose Level 1-3 |
Primary outcome
To determine the maximum number of suicide gene-modified allodepleted donor lymphocytes that can be given to recipients of haploidentical stem cell transplants that will result in a rate of Grade III/IV GVHD of 25% or less.
Time frame: 45 days
Maximum tolerated dose of suicide gene-modified allodepleted donor lymphocytes up to a total of 1 x 10e7/kg per dose.
4 secondary outcomes
To evaluate the biological effects of administration of AP1903, a dimerizer used to activate the suicide gene mechanism, and its clinical effects in patients who develop GvHD.
Time frame: 1 year
To analyze the contribution of the gene-modified cells to immune reconstitution in these patients by measuring their survival, persistence and expansion.
Time frame: 15 years
To measure the overall and disease-free survival at 100 days and at 1 year post-transplant.
Time frame: 1 year
To obtain preliminary information on whether subjects receiving additional doses of cells show a cumulative rise in the percentage of circulating gene-modified cells.
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 26639404Chang EC, Liu H, West JA, Zhou X, Dakhova O, Wheeler DA, Heslop HE, Brenner MK, Dotti G. Clonal Dynamics In Vivo of Virus Integration Sites of T Cells Expressing a Safety Switch. Mol Ther. 2016 Apr;24(4):736-45. doi: 10.1038/mt.2015.217. Epub 2015 Dec 7.
- Derived from this study: PubMed 26072403Zhou X, Di Stasi A, Brenner MK. iCaspase 9 Suicide Gene System. Methods Mol Biol. 2015;1317:87-105. doi: 10.1007/978-1-4939-2727-2_6.
- Derived from this study: PubMed 24753538Zhou X, Di Stasi A, Tey SK, Krance RA, Martinez C, Leung KS, Durett AG, Wu MF, Liu H, Leen AM, Savoldo B, Lin YF, Grilley BJ, Gee AP, Spencer DM, Rooney CM, Heslop HE, Brenner MK, Dotti G. Long-term outcome after haploidentical stem cell transplant and infusion of T cells expressing the inducible caspase 9 safety transgene. Blood. 2014 Jun 19;123(25):3895-905. doi: 10.1182/blood-2014-01-551671. Epub 2014 Apr 21.
- Derived from this study: PubMed 22047558Di Stasi A, Tey SK, Dotti G, Fujita Y, Kennedy-Nasser A, Martinez C, Straathof K, Liu E, Durett AG, Grilley B, Liu H, Cruz CR, Savoldo B, Gee AP, Schindler J, Krance RA, Heslop HE, Spencer DM, Rooney CM, Brenner MK. Inducible apoptosis as a safety switch for adoptive cell therapy. N Engl J Med. 2011 Nov 3;365(18):1673-83. doi: 10.1056/NEJMoa1106152.
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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 principal investigator
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 Allodepleted T Cells in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's 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 17 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the maximum number of suicide gene-modified allodepleted donor lymphocytes that can be given to recipients of haploidentical stem cell transplants that will result in a rate of Grade III/IV GVHD of 25% or less. (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00710892, which also lists 4 linked publications.
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 1 Jul 2026.