A Phase 1 interventional study of Pembrolizumab in Myelodysplastic Syndromes, Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by University of Michigan Rogel Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by University of Michigan Rogel Cancer Center · Phase 1, Interventional, and Treatment
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Among 1,363 studies in Myelodysplastic Syndromes with a site in United States — 174 open to participants now, 279 under way, 17 of them phase 3. Myelodysplastic Syndromes · United States.
Among the 1,363 studies in Myelodysplastic Syndromes with a site in United States, this one is the 877th largest by enrollment of the 1,189 interventional ones that give a count, is one of 59 that started in 2017, is one of 384 in phase 1, and was the 975th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →174 of the 1,363 studies in Myelodysplastic Syndromes with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 12–120
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 1 days–99 yrs
City of Hope Medical Center · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,363 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 572 · Phase 2 720 · Phase 3 82 · Phase 4 6
First in 1984; this study’s year is marked. 59 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 35 across the 1,189 interventional studies, 145 across the 94 observational. Of the 1,000 that completed or were terminated, 465 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
338 of 1,363 have an industry lead sponsor. The 10 most frequent:
University of Michigan Rogel Cancer Center is the lead sponsor of 325 studies on the registry; 49 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
University of Michigan Rogel Cancer Center has 7 studies filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
92 of the studies in Myelodysplastic Syndromes with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04401748Phase 3AbbVieStudy Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome | 2027-07 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT06465953Phase 3Institut de Recherches Internationales ServierIvosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation | 2027-11-01 |
| NCT03121014University of Illinois at ChicagoStudy of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes | 2026-11 |
| NCT05362773MacroGenicsA Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies | 2026-11 |
Add all 92 to your calendar (.ics) → With an account.
Among the 1,363 studies in Myelodysplastic Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single arm, open-label, Phase 1b study of pembrolizumab for patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) whose disease has relapsed after receiving allogeneic hematopoetic stem cell transplant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pembrolizumab
200mg IV every 21 days
Also known as: KEYTRUDA
The Number of Patients That Demonstrate Clinical Benefit From Treatment
This study will assess if the study drug is promising for further study. The study drug will be considered promising if at least 4 patients receive a clinical benefit or if any complete response is seen. Clinical benefit is defined as either stable disease, partial remission or complete remission to treatment. Complete remission (CR) will be defined as achieving a morphologic leukemia free state by achieving all of the following criteria: bone marrow myeloblasts \< 5% by morphologic assessment; AND absence of circulating blasts with phenotypic or morphologic features of leukemia (e.g. Auer rods) AND no evidence of extramedulary disease. Partial remission (PR) will be defined as a ≥ 50% reduction in bone marrow blast percentage to 5-25% or marrow blasts \< 5% with persistent Auer rods, flow cytometric or cytogenetic disease. SD will be defined as ≤ 5% increase in blasts or decreased blast percentage in the bone marrow that does not meet the criteria for PR.
Time frame: Day 77
The Number of Patients That Respond to Treatment
This study will assess the number of patients that respond to treatment by overall response rate (ORR). ORR is defined as the number of patients will complete remission and partial remission. Complete remission (CR) will be defined as achieving a morphologic leukemia free state by achieving all of the following criteria: bone marrow myeloblasts \< 5% by morphologic assessment; AND absence of circulating blasts with phenotypic or morphologic features of leukemia (e.g. Auer rods) AND no evidence of extramedulary disease. Partial remission (PR) will be defined as a ≥ 50% reduction in bone marrow blast percentage to 5-25% or marrow blasts \< 5% with persistent Auer rods, flow cytometric or cytogenetic disease.
Time frame: Day 77
Graft Versus Host Disease (GvHD) or Other Significant Immune Mediated Toxicities
The number of patients that experience Graft Versus Host Disease (GvHD) or other significant immune mediated toxicities
Time frame: 30 Days Post Treatment
Overall Survival
The number of patients alive at 1 year
Time frame: 1 Year
Event- Free Survival
The number of patients alive at 1 year without disease
Time frame: 1 Year
| Milestone | Pembrolizumab |
|---|---|
| Started | 16 |
| Completed | 7 |
| Not completed | 9 |
| Withdrew: Adverse event | 6 |
| Withdrew: Death | 3 |
This study will assess if the study drug is promising for further study. The study drug will be considered promising if at least 4 patients receive a clinical benefit or if any complete response is seen. Clinical benefit is defined as either stable disease, partial remission or complete remission to treatment. Complete remission (CR) will be defined as achieving a morphologic leukemia free state by achieving all of the following criteria: bone marrow myeloblasts \< 5% by morphologic assessment; AND absence of circulating blasts with phenotypic or morphologic features of leukemia (e.g. Auer rods) AND no evidence of extramedulary disease. Partial remission (PR) will be defined as a ≥ 50% reduction in bone marrow blast percentage to 5-25% or marrow blasts \< 5% with persistent Auer rods, flow cytometric or cytogenetic disease. SD will be defined as ≤ 5% increase in blasts or decreased blast percentage in the bone marrow that does not meet the criteria for PR.
| Participants | Pembrolizumab |
|---|---|
| The Number of Patients That Demonstrate Clinical Benefit From Treatment | 6 |
This study will assess the number of patients that respond to treatment by overall response rate (ORR). ORR is defined as the number of patients will complete remission and partial remission. Complete remission (CR) will be defined as achieving a morphologic leukemia free state by achieving all of the following criteria: bone marrow myeloblasts \< 5% by morphologic assessment; AND absence of circulating blasts with phenotypic or morphologic features of leukemia (e.g. Auer rods) AND no evidence of extramedulary disease. Partial remission (PR) will be defined as a ≥ 50% reduction in bone marrow blast percentage to 5-25% or marrow blasts \< 5% with persistent Auer rods, flow cytometric or cytogenetic disease.
| Participants | Pembrolizumab |
|---|---|
| The Number of Patients That Respond to Treatment | 3 |
The number of patients that experience Graft Versus Host Disease (GvHD) or other significant immune mediated toxicities
| Participants | Pembrolizumab |
|---|---|
| GVHD | 9 |
| mmune-related SAEs | 2 |
The number of patients alive at 1 year
| percentage of participants | Pembrolizumab |
|---|---|
| Overall Survival | 37.5 (15.4 to 59.8) |
The number of patients alive at 1 year without disease
| percentage of participants | Pembrolizumab |
|---|---|
| Event- Free Survival | 31.3 (11.1 to 53.7) |
Collected over All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. An average of 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab | 12/16 (75%) | 16/16 (100%) | 6/16 (37.5%) |
| Event | Pembrolizumab |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 7/16 |
| Immune system disorders - Other, specifyImmune system disorders | 5/16 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 3/16 |
| Immune system disorders - Other, specifyImmune system disorders | 3/16 |
| Blood bilirubin increasedInvestigations | 2/16 |
| FeverGeneral disorders | 2/16 |
| Lung infectionInfections and infestations | 2/16 |
| SepsisInfections and infestations | 2/16 |
| Acute kidney injuryRenal and urinary disorders | 1/16 |
| Alanine aminotransferase increasedInvestigations | 1/16 |
| Event | Pembrolizumab |
|---|---|
| Alanine aminotransferase increasedInvestigations | 2/16 |
| Aspartate aminotransferase increasedInvestigations | 2/16 |
| Immune system disorders - Other, specifyImmune system disorders | 2/16 |
| Blood bilirubin increasedInvestigations | 1/16 |
| DehydrationMetabolism and nutrition disorders | 1/16 |
| HyponatremiaInvestigations | 1/16 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/16 |
| Age, Categorical(Participants) | Pembrolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Pembrolizumab |
|---|---|
| Female | 7 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Pembrolizumab |
|---|---|
| United States | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Oct 2020, 34 months.
Results were first posted in May 2025, 4 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pembrolizumab
University of Michigan Rogel Cancer Center →