18 and older, any sex, with High Risk Myelodysplastic Syndrome or Recurrent 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.
Participants With a ResponsePrimary· Up to 5 years
Response rate as determined by the International Working Group recommendations. Complete remission (CR): The patient must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1.0 x 109/L, platelet count \>/- 100 x 109/L, and normal bone marrow differential (\</= 5% blasts). Complete remission without platelet recovery (CRp): As per CR but platelet count \< 100 x 109/L. Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Marrow CR: Bone marrow: \</= 5% myeloblasts and decrease by \>/= 50% over pre-treatme
Group
Value
95% CI
Treatment (Daratumumab)
0
Time on TreatmentSecondary· Up to 5 years
Time from date of start of study medication until date of off study.
Group
Value
95% CI
Treatment (Daratumumab)
1.1
0.2 – 3.0
Overall SurvivalSecondary· Up to 5 years
Time from date of treatment start until date of death due to any cause or last Follow-up.
Group
Value
95% CI
Treatment (Daratumumab)
4.2
0.2 – 9.2
Progression Free SurvivalSecondary· Up to 5 years
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Group
Value
95% CI
Treatment (Daratumumab)
1.1
0.2 – 3.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well daratumumab works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment or high-risk myelodysplastic syndrome. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients
· Phase 1
· not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk
· Phase 2, PHASE3
· not yet recruiting
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
· Phase 2, PHASE3
· not yet recruiting
NCT07393282 — A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
· Phase 3
· not yet recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi
· Phase 3
· recruiting
Other recruiting trials for High Risk Myelodysplastic Syndrome
Currently open trials in the same condition.
NCT04128748 — Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Ris
· Phase 1, PHASE2
· recruiting
NCT04262843 — Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With
· Phase 2
· active not recruiting
NCT04047641 — Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory A
· Phase 1, PHASE2
· recruiting
NCT02530034 — Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
· Phase 1
· active not recruiting
NCT03672539 — Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory
· Phase 2
· active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· 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 M.D. Anderson Cancer Center
Last refreshed: 21 September 2023
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/NCT03067571.