Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03957876 · ClinicalTrials.gov registry record · Phase 2
CPX-351 Therapy for MDS After Hypomethylating Agent Failure
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03957876: Clinical Trial Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT03957876 is a Phase 2 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03957876, a Phase 2 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of treatment with CPX-351 (an FDA approved drug for the treatment of AML) in individuals with MDS while using a new stratification tool to predict outcomes of participants following HMA failure. This approach is intended to gain a better understanding and insight into identifying new opportunities for drug approvals in this setting.
Primary Outcome
Efficacy of CPX as measured by ORR as defined by IWG 2006 criteria for MDS participants at end of induction. IWG 2006 responses that must be for at least 4 weeks include Complete Remission (CR), Partial Remission (PR), Marrow CR, Stable Disease (SD), Failure, Relapse after CR or PR (PD), or cytogenetic response. Hematologic Improvement (HI), which must be for at least 8 weeks, includes erythroid response (pretreatment, \< 11 g/dL), Platelet response (pretreatment, \< 100x109/L), Neutrophil respo
Interventions
- DRUG CPX-351
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 2 |
Why NCT03957876 stopped before completion
NCT03957876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which CPX-351 is the first listed.
NCT03957876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03957876 about?
NCT03957876 is a clinical study titled "CPX-351 Therapy for MDS After Hypomethylating Agent Failure". The purpose of this study is to evaluate the efficacy of treatment with CPX-351 (an FDA approved drug for the treatment of AML) in individuals with MDS while using a new stratification tool to predict outcomes of participants following HMA failure. This approach is intended to gain a better understa...
What is the current status of trial NCT03957876?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-07-25. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03957876?
The interventions under investigation include: CPX-351 (DRUG).
Who is sponsoring clinical trial NCT03957876?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03957876's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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 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