Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04582864 · ClinicalTrials.gov registry record · Phase 2
Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04582864: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT04582864 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04582864, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The investigators hypothesize that flotetuzumab for relapsed AML following allo-HCT will be safe, tolerable and may facilitate preferential immune effector cell retargeting of leukemic cells resulting in improved patient outcomes. Furthermore, administration of a donor lymphocyte infusion (DLI) (if available) in combination with flotetuzumab will be safe, tolerable and may provide additional therapeutic efficacy.
Primary Outcome
* Complete remission without minimal residual disease (CRmrd): CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC * Complete remission (CR): Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); platelet count ≥100 × 10\^9/L (100,000/µL), transfusion independence * CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 × 10\^9/L
Interventions
- DRUG Flotetuzumab
- PROCEDURE Donor lymphocyte infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 2 |
Why NCT04582864 stopped before completion
NCT04582864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Flotetuzumab is the first listed.
NCT04582864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04582864 about?
NCT04582864 is a clinical study titled "Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)". The investigators hypothesize that flotetuzumab for relapsed AML following allo-HCT will be safe, tolerable and may facilitate preferential immune effector cell retargeting of leukemic cells resulting in improved patient outcomes. Furthermore, administration of a donor lymphocyte infusion (DLI) (if ...
What is the current status of trial NCT04582864?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2021-05-20. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT04582864?
The interventions under investigation include: Flotetuzumab (DRUG), Donor lymphocyte infusion (PROCEDURE).
Who is sponsoring clinical trial NCT04582864?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04582864's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI