Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06634394 · ClinicalTrials.gov registry record · Phase 1
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
A Phase 1 study of Acute Myeloid Leukemia (AML), sponsored by Aptevo Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 7
- Study locations
NCT06634394: Recruiting Phase 1 study of Acute Myeloid Leukemia (AML), sponsored by Aptevo Therapeutics.
NCT06634394 is a Phase 1 study of Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by Aptevo Therapeutics. The registered enrollment target is 39 participants, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (73% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06634394, a Phase 1 study of Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by Aptevo Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 7
- Study locations
Study Summary
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
Primary Outcome
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome \[CRS\]).
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG APVO436
Study Locations (7)
Ohio
- Gabrail Cancer Center - Canton
- Oncology Hematology Care - Cincinnati
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson Cancer Center - Houston
Colorado
- Colorado Blood Cancer Institute - Denver
Florida
- University of Miami - Miami
Kansas
- University of Kansas - Fairway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
What NCT06634394 shows while recruiting
NCT06634394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06634394 lists 7 locations in 5 states (Ohio, Texas, Colorado).
Frequently Asked Questions
What is clinical trial NCT06634394 about?
NCT06634394 is a clinical study titled "APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML". A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
What is the current status of trial NCT06634394?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2024-10-01. Estimated completion is 2028-03.
What conditions does trial NCT06634394 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT06634394?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), APVO436 (DRUG).
Who is sponsoring clinical trial NCT06634394?
This trial is sponsored by Aptevo Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06634394 being conducted?
This trial has 7 study locations across Colorado, Florida, Kansas, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia (AML)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06634394's enrollment target sits among peer trials
39 21st of 29 higher than 9 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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
-
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
RECRUITING · Phase 1
-
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
RECRUITING · Phase 1
-
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
RECRUITING · Phase 1
-
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 1
-
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
ACTIVE NOT RECRUITING · Phase 1
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
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
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