Adults 18 to 99, any sex, with Relapsed Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of a Novel Combination of Pembrolizumab and Decitabine in Relapsed/Refractory Acute Myeloid Leukemia ParticipantsPrimary· 24 weeks
The number of patients who could be treated with a novel combination of Pembrolizumab and Decitabine in relapsed/refractory Acute Myeloid Leukemia participants without being removed from the protocol due to treatment related toxicities.
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
10
Median Days to First Response From Start of Study to Initial Achievement of First Response (mCR, mCRi, CR, CRi, PR, or SD)Secondary· At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24)
Time to first response (days) is time from start of study to first response (mCR, mCRi, CR, CRi, PR, or SD) in relapsed/refractory acute myeloid leukemia (AML) participants.
Measurable residual disease (MRD) negative complete remission is no evidence of residual disease, \< 5% blasts, no Auer rods and may be with mCR or without count recovery (ANC ≥ 1,000/mcl and platelet count ≥ 100,000/mcl) as mCRi. Morphologic complete remission (CR) is ANC ≥ 1,000/mcl, platelet count ≥ 100,000/mcl, \< 5% blasts, no Auer rods, no evidence of disease; Morphologic complete remission with incomplete blood cou
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
42
37 – 49
Median Days to Best Response From Start of Study to Initial Achievement of Best Response (by the Order of mCR, mCRi, CR, CRi, PR, or SD)Secondary· At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24)
Time to Best Response is defined as time (days) from start of study to initial achievement of best response. Best response is defined by the order of mCR, mCRi, CR, CRi, PR, or SD. Measurable residual disease (MRD) negative complete remission is no evidence of residual disease, \< 5% blasts, no Auer rods and may be with mCR or without count recovery (ANC ≥ 1,000/mcl and platelet count ≥ 100,000/mcl) as mCRi. Morphologic complete remission (CR) is ANC ≥ 1,000/mcl, platelet count ≥ 100,000/mcl, \< 5% blasts, no Auer rods, no evidence of disease; Morphologic complete remission with incomplete blo
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
42
39 – 159
Median Duration (Days) of Response From Initial Achievement of Response to Loss of Response (mCR, mCRi, CR, CRi, PR, or SD)Secondary· At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24)
To determine duration (days) of response as defined as time from initial achievement of response to loss of response (mCR, mCRi, CR, CRi, PR, or SD).
Measurable residual disease (MRD) negative complete remission is no evidence of residual disease, \< 5% blasts, no Auer rods and may be with mCR or without count recovery (ANC ≥ 1,000/mcl and platelet count ≥ 100,000/mcl) as mCRi. Morphologic complete remission (CR) is ANC ≥ 1,000/mcl, platelet count ≥ 100,000/mcl, \< 5% blasts, no Auer rods, no evidence of disease; Morphologic complete remission with incomplete blood count recovery (CRi) is sam
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
148
12 – 337
Median Duration (Days) of Best Response From Initial Achievement of Best Response to Loss of Best Response (by the Order of mCR, mCRi, CR, CRi, PR, or SD)Secondary· At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24)
Duration of Best Response is time (days) from initial achievement of best response to loss of best response. Best response is defined by the order of mCR, mCRi, CR, CRi, PR, or SD. Measurable residual disease (MRD) negative complete remission is no evidence of residual disease, \< 5% blasts, no Auer rods and may be with mCR or without count recovery (ANC ≥ 1,000/mcl and platelet count ≥ 100,000/mcl) as mCRi. Morphologic complete remission (CR) is ANC ≥ 1,000/mcl, platelet count ≥ 100,000/mcl, \< 5% blasts, no Auer rods, no evidence of disease; Morphologic complete remission with incomplete blo
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
148
12 – 316
Overall SurvivalSecondary· from enrollment until date of death, assessed up to 24 weeks
Number of participants overall survival is defined as death from any cause
Group
Value
95% CI
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab and Decitabine for Treatment of Acute Myeloid Leukemia
Serious: 7/10 (70%)
Deaths: 0/10
Serious adverse events (12 terms)
Reaction
System
Pembrolizumab and Decitabi…
Febrile neutropenia
Blood and lymphatic system disorders
—
Pain
General disorders
—
Sepsis
Infections and infestations
—
Hypokalaemia
Metabolism and nutrition disorders
—
Diarrhoea
Gastrointestinal disorders
—
Wound infection bacterial
Infections and infestations
—
Blood culture positive
Investigations
—
Hypophosphataemia
Metabolism and nutrition disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Headache
Nervous system disorders
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
Hypotension
Vascular disorders
—
Other adverse events (148 terms — click to expand)
Background:
Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not treated. Treatment for AML that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.
Objective:
To test if pembrolizumab, in combination with decitabine, is a possible treatment for people with relapsed or refractory AML.
Eligibility:
Adults 18 years of age and older with refractory AML or relapsed AML.
Design:
Participants will be first screened for eligibility.
The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles. Participants may be in the study for up to 2 years if they are responding to the treatment.
The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an outpatient.
Participants will get pembrolizumab at the beginning of each cycle through an IV.
Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other cycle.
Participants will give blood samples.
Participants will have bone marrow exams. A needle will be inserted into the hip to extract cells from the bone marrow.
Some participants may give a sample of saliva from the inside of their cheek.
Some participants may give a small skin sample. The top layer of the skin is removed.
Some patients may require leukapheresis before starting treatment. This is a procedure to remove leukemia cells in the blood stream.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Relapsed Acute Myeloid Leukemia
Currently open trials in the same condition.
NCT06741722 — Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
· Phase 2
· recruiting
NCT06536959 — VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
· Phase 2
· recruiting
NCT06017258 — A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
· Phase 1
· recruiting
NCT04797767 — Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
· Phase 1, PHASE2
· recruiting
Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease
· Phase 1
· not yet recruiting
NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System
· NA
· enrolling by invitation
NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti
· not yet recruiting
NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 28 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02996474.