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COMPLETED Phase 1

A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML)

NCT00875693 · View on ClinicalTrials.gov ↗

Study Summary

This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for CPX-351 followed by a reduced intensity conditioning regimen and incorporates a dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an expanded safety cohort(s) at the MTD. Refractory and relapsed AML patients who meet standard institutional criteria to undergo sequential induction/reduced intensity conditioning allogeneic transplants will be offered a transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood transplants will not be used in this study.

Interventions

  • DRUG CPX-351

Study Locations (1)

New York

  • Weill Cornell Medical College — New York

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2009-06-02
Est. Completion 2017-12-27
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00875693

The ClinicalTrials.gov registry entry for NCT00875693 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 679 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention — of which CPX-351 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00875693 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00875693 about?

NCT00875693 is a clinical study titled "A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML)". This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for CPX-351 followed by a reduced intensity conditioning regimen and incorporates a dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination of the MTD, the investigator reserv...

What is the current status of trial NCT00875693?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2009-06-02. Estimated completion is 2017-12-27.

What conditions does trial NCT00875693 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Myelogenous Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00875693?

The interventions under investigation include: CPX-351 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00875693?

This trial is sponsored by Weill Medical College of Cornell University, which has 679 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00875693 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial