Acute Myeloid LeukemiaPhase 1NCT02494167
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)
A Phase 1 study testing MultiTAA-specific T cells in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard treatment, including… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- MultiTAA-specific T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as;
- Adjuvant therapy for AML/MDS (Group A) or
- Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B)
- Residual disease at the time of transplant or post transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood or any other extramedullary sites.
- Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues of any of the following:
- Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation.
Show all 21Show fewer
- Expression of a leukemia associated antigen known to be a marker for residual disease like WT1.
- A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or HLA-DR+) post-transplant at a level of ≥ 0.01%.
- Mixed donor chimerism (> 20%).
- Life expectancy ≥ 6 weeks.
- Karnofsky/Lansky score of ≥ 50.
- Patient or parent/guardian capable of providing informed consent.
- Bilirubin ≤ 2X upper limit of normal.
- AST ≤ 3X upper limit of normal.
- Undergoing stem cell transplant at CAGT.
- Serum creatinine ≤ 2X upper limit of normal.
- Hgb ≥ 7.0 g/dL (can be transfused).
- Pulse oximetry of > 90% on room air.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. Male partner should use a condom.
- Available donor-derived multiTAA-specific T cell line.
- No other investigational anti-neoplastic therapy for one month prior to entry in this study.
Who cannot join
- Patients receiving ATG or Campath within 28 days of infusion.
- Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion.
- Less than 30 days post-allogeneic stem cell transplant.
- Severe intercurrent infection.
- Evidence of GVHD > Grade II.
- Pregnant or lactating.
- Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Administration of Donor Derived Multi-Tumor-Associated Antigen (TAA)- Specific T Cells to Patients With AML or MDS (ADSPAM)
This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT).
The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. The investigators previously tested whether special white blood cells (called T cells) that were trained to kill EBV-infected cells could affect these tumors, and in many patients the investigators found that giving these trained T cells causes a complete or partial response.
Read more
Other cancers express specific proteins that can be targeted in the same way. The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment appears to be safe. Therefore, the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so they either do not show up, or show up in low quantities, or normal human cells.
The investigators will grow T cells from patients' stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin, which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30 days post-allogeneic stem cell transplant. In this study, the investigators want see whether these cells will be able to recognize and kill cancer cells that express these proteins. These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the U.S. Food and Drug Administration
The purpose of this study is to find the largest safe dose of donor-derived tumor protein multiTAA-specific T cells for patients with AML or MDS.
Read the detailed description
To make donor derived multiTAA-specific T cells, the investigators will collect blood from the patient's stem cell donor, and mix the donor's T cells with small pieces of tumor proteins WT1, PRAME, NY-ESO-1, and Survivin. These protein fragments stimulate the donor T cells to grow and react against these proteins in such a way that they will recognize and kill cancer cells that express these proteins. Once sufficient numbers of multiTAA-specific T cells have been made, the investigators test them to make sure they target the patient's cancer cells, but not their normal healthy cells.
The multiTAA-specific T cells will be administered as a single intravenous (IV) infusion over 10 minutes. The patient's cancer will be assessed within 4 weeks prior to the T cell infusion, and then 4-6 weeks after the infusion. If at least 4 weeks after the infusion there is no change or a reduction in the number of cancer cells measured in the bone marrow, or a decline in cancer-specific markers in the blood, patients may receive up to six (6) additional doses of T cells at least 4 weeks apart. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's Hospital.
For at least 4 weeks after the infusion, patients may not receive any other anti-cancer treatments, such as radiation therapy, or chemotherapy. Patients who do receive any other therapies will be taken off treatment and will not be able to receive additional doses of T cells. However, drugs such as 5-azacytidine (Vidaza), decitabine (Dacogen), or lenalidomide (Revlimid), tyrosine kinase inhibitors like sorafenib and mild cytoreductive agents such as hydroxyurea will be allowed during infusions.
This is a dose escalation study, which means that at the beginning, patients will be started on the lowest dose (1 of 5 different levels) of T cells. Once that dose level proves safe, the next group of patients will be started at the next highest dose. This process will continue until all 5 dose levels have been studied. If side-effects are too severe, the dose will be lowered or the T cells injections will be stopped.
MEDICAL TESTS BEFORE TREATMENT:
Before being treated, patients will undergo a series of standard medical tests:
- Measurement of AML/MDS (done by bone marrow biopsy or tests on blood or other tissues)
- Pregnancy test, if patient is a female who can have children.
MEDICAL TESTS DURING TREATMENT
Patients will undergo standard medical tests on the day of infusion:
- Physical exam.
- Blood test to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT:
- Blood tests to measure blood cells, kidney and liver function on week 4.
- Measurement of AML/MDS 4-6 weeks after the T cells infusion and 8-12 weeks after the infusion (done by bone marrow biopsy and tests done on your blood or other tissues).
To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, and at weeks 1, 2, 4 and 8. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the infusion. Blood should come from the central intravenous line, and should not require extra needle sticks. Investigators will use this blood to see how long the T cells last, and to look at the immune response to the patient's cancer. Investigators will also look at this in bone marrow and other tissue samples collected from the patient at the time points stated above (pre-infusion, 4 - 6 weeks and 8 - 12 weeks post infusion).
Patients will be followed for up to one year from the date of the last T cell infusion, so that the investigators can learn more about the way the T cells are working, how long the T cells last in the body, and to assess the immune response to the cancer. Patients who receive additional doses of T cells will undergo the same tests and evaluations performed for each dose as described above.
Patients will then be contacted once a year for up to 4 additional years (total of 5 years follow-up) to evaluate their disease response long-term.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- MultiTAA-specific T cells
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, MultiTAA Specific T cells
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiTAA-specific T cellsBiological
Also called Multiple tumor-associated antigen (TAA)-specific T cells
The 5 dose levels are:
Dose Level 1: 5 x 10e6 cells/m2; Dose Level 2: 1 x 10e7 cells/m2; Dose Level 3: 2 x 10e7 cells/m2; Dose Level Four: 5 x 10e7 cells/m2; Dose Level Five: 1 x 10e8 cells/m2
The T cells are given from 30 days post-HSCT. They are administered by intravenous injection over 1-10 minutes through either a peripheral or central lie.
In patients being treated as adjuvant therapy or if patients with residual disease, have a complete response or stable disease, they will be eligible to receive up to 6 further doses of multiTAA-specific T cells at the same dose as the initial infusions (or below the patient's original dose can be administered) at least 4 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment with donor-derived multiTAA-specific T cells as adjuvant therapy following HSCT for AML or MDS Receives: Biological: MultiTAA-specific T cells |
| Group B | Experimental | Treatment with donor-derived multiTAA-specific T cells for relapsed/residual disease following HSCT for AML or MDS Receives: Biological: MultiTAA-specific T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose-limiting toxicities (DLTs).
Maximum tolerated dose (MTD) of multiTAA-specific T cells among the five pre-specified dose levels.
Measured: 4 weeks
Secondary outcomes (2)
Number of patients with a decrease in the marker of disease.
To obtain information on the anti-tumor effects of adoptively transferred donor-derived multiTAA-specific T cells in patients with AML or MDS.
Measured: 4 weeks
Median number of T cells post-infusion.
To obtain information on the expansion and persistence of adoptively transferred donor-derived multiTAA-specific T cells in patients with AML or MDS.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2025
- Study completionJun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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, American Society for Blood and Marrow Transplantation (ASBMT), Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Premal Lulla, Baylor College of Medicine
- Investigators
- Premal Lulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494167
- Sponsor's protocol ID
- H-36346 ADSPAM
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2015
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lulla PD, Naik S, Vasileiou S, Tzannou I, Watanabe A, Kuvalekar M, Lulla S, Carrum G, Ramos CA, Kamble R, Hill L, Randhawa J, Gottschalk S, Krance R, Wang T, Wu M, Robertson C, Gee AP, Chung B, Grilley B, Brenner MK, Heslop HE, Vera JF, Leen AM. Clinical effects of administering leukemia-specific donor T cells to patients with AML/MDS after allogeneic transplant. Blood. 2021 May 13;137(19):2585-2597. doi: 10.1182/blood.2020009471.
PubMed 33270816
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Donor Derived Multi-Tumor-Associated Antigen (TAA)- Specific T Cells to Patients With AML or MDS (ADSPAM)
- ClinicalTrials.gov ID
- NCT02494167
- Acronym / sponsor ID
- H-36346 ADSPAM
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, MultiTAA Specific T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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, American Society for Blood and Marrow Transplantation (ASBMT), Cancer Prevention Research Institute of Texas
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2025 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT).
The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. The investigators previously tested whether special white blood cells (called T cells) that were trained to kill EBV-infected cells could affect these tumors, and in many patients the investigators found that giving these trained T cells causes a complete or partial response.
Other cancers express specific proteins that can be targeted in the same way. The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment appears to be safe. Therefore, the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so they either do not show up, or show up in low quantities, or normal human cells.
The investigators will grow T cells from patients' stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin, which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30 days post-allogeneic stem cell transplant. In this study, the investigators want see whether these cells will be able to recognize and kill cancer cells that express these proteins. These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the U.S. Food and Drug Administration
The purpose of this study is to find the largest safe dose of donor-derived tumor protein multiTAA-specific T cells for patients with AML or MDS.
Detailed description
To make donor derived multiTAA-specific T cells, the investigators will collect blood from the patient's stem cell donor, and mix the donor's T cells with small pieces of tumor proteins WT1, PRAME, NY-ESO-1, and Survivin. These protein fragments stimulate the donor T cells to grow and react against these proteins in such a way that they will recognize and kill cancer cells that express these proteins. Once sufficient numbers of multiTAA-specific T cells have been made, the investigators test them to make sure they target the patient's cancer cells, but not their normal healthy cells.
The multiTAA-specific T cells will be administered as a single intravenous (IV) infusion over 10 minutes. The patient's cancer will be assessed within 4 weeks prior to the T cell infusion, and then 4-6 weeks after the infusion. If at least 4 weeks after the infusion there is no change or a reduction in the number of cancer cells measured in the bone marrow, or a decline in cancer-specific markers in the blood, patients may receive up to six (6) additional doses of T cells at least 4 weeks apart. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's Hospital.
For at least 4 weeks after the infusion, patients may not receive any other anti-cancer treatments, such as radiation therapy, or chemotherapy. Patients who do receive any other therapies will be taken off treatment and will not be able to receive additional doses of T cells. However, drugs such as 5-azacytidine (Vidaza), decitabine (Dacogen), or lenalidomide (Revlimid), tyrosine kinase inhibitors like sorafenib and mild cytoreductive agents such as hydroxyurea will be allowed during infusions.
This is a dose escalation study, which means that at the beginning, patients will be started on the lowest dose (1 of 5 different levels) of T cells. Once that dose level proves safe, the next group of patients will be started at the next highest dose. This process will continue until all 5 dose levels have been studied. If side-effects are too severe, the dose will be lowered or the T cells injections will be stopped.
MEDICAL TESTS BEFORE TREATMENT:
Before being treated, patients will undergo a series of standard medical tests:
- Measurement of AML/MDS (done by bone marrow biopsy or tests on blood or other tissues)
- Pregnancy test, if patient is a female who can have children.
MEDICAL TESTS DURING TREATMENT
Patients will undergo standard medical tests on the day of infusion:
- Physical exam.
- Blood test to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT:
- Blood tests to measure blood cells, kidney and liver function on week 4.
- Measurement of AML/MDS 4-6 weeks after the T cells infusion and 8-12 weeks after the infusion (done by bone marrow biopsy and tests done on your blood or other tissues).
To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, and at weeks 1, 2, 4 and 8. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the infusion. Blood should come from the central intravenous line, and should not require extra needle sticks. Investigators will use this blood to see how long the T cells last, and to look at the immune response to the patient's cancer. Investigators will also look at this in bone marrow and other tissue samples collected from the patient at the time points stated above (pre-infusion, 4 - 6 weeks and 8 - 12 weeks post infusion).
Patients will be followed for up to one year from the date of the last T cell infusion, so that the investigators can learn more about the way the T cells are working, how long the T cells last in the body, and to assess the immune response to the cancer. Patients who receive additional doses of T cells will undergo the same tests and evaluations performed for each dose as described above.
Patients will then be contacted once a year for up to 4 additional years (total of 5 years follow-up) to evaluate their disease response long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: MultiTAA-specific T cellsTreatment with donor-derived multiTAA-specific T cells as adjuvant therapy following HSCT for AML or MDS |
| Group B | Experimental | Biological: MultiTAA-specific T cellsTreatment with donor-derived multiTAA-specific T cells for relapsed/residual disease following HSCT for AML or MDS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as;
- Residual disease at the time of transplant or post transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood or any other extramedullary sites.
- Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues of any of the following:
- Life expectancy ≥ 6 weeks.
- Karnofsky/Lansky score of ≥ 50.
Key exclusion criteria (7 listed)
- Patients receiving ATG or Campath within 28 days of infusion.
- Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion.
- Less than 30 days post-allogeneic stem cell transplant.
- Severe intercurrent infection.
- Evidence of GVHD > Grade II.
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 |
|---|---|---|
| MultiTAA-specific T cellsAlso: Multiple tumor-associated antigen (TAA)-specific T cellsThe 5 dose levels are: Dose Level 1: 5 x 10e6 cells/m2; Dose Level 2: 1 x 10e7 cells/m2; Dose Level 3: 2 x 10e7 cells/m2; Dose Level Four: 5 x 10e7 cells/m2; Dose Level Five: 1 x 10e8 cells/m2 The T cells are given from 30 days post-HSCT. They are administered by intravenous injection over 1-10 minutes through either a peripheral or central lie. In patients being treated as adjuvant therapy or if patients with residual disease, have a complete response or stable disease, they will be eligible to receive up to 6 further doses of multiTAA-specific T cells at the same dose as the initial infusions (or below the patient's original dose can be administered) at least 4 weeks apart. | Biological | Group A, Group B |
Primary outcome
Number of patients with dose-limiting toxicities (DLTs).
Time frame: 4 weeks
Maximum tolerated dose (MTD) of multiTAA-specific T cells among the five pre-specified dose levels.
2 secondary outcomes
Number of patients with a decrease in the marker of disease.
Time frame: 4 weeks
Median number of T cells post-infusion.
Time frame: 1 year
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 26 Aug 2026.
- Derived from this study: PubMed 33270816Lulla PD, Naik S, Vasileiou S, Tzannou I, Watanabe A, Kuvalekar M, Lulla S, Carrum G, Ramos CA, Kamble R, Hill L, Randhawa J, Gottschalk S, Krance R, Wang T, Wu M, Robertson C, Gee AP, Chung B, Grilley B, Brenner MK, Heslop HE, Vera JF, Leen AM. Clinical effects of administering leukemia-specific donor T cells to patients with AML/MDS after allogeneic transplant. Blood. 2021 May 13;137(19):2585-2597. doi: 10.1182/blood.2020009471.
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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.
Premal Lulla, 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 MultiTAA-specific T cells in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, 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 21 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: finished, as of the sponsor's last update on 26 Aug 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?
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?
Number of patients with dose-limiting toxicities (DLTs). (time frame: 4 weeks). 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 NCT02494167, which also lists 1 linked publication.
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 26 Aug 2026.