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NCT04195945 · ClinicalTrials.gov registry record · Phase 2
CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients
A Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm, sponsored by Fred Hutchinson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04195945: Active Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm, sponsored by Fred Hutchinson Cancer Center.
NCT04195945 is a Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195945, a Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, cladribine, cytarabine, G-CSF, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CPX-351 or the CLAG-M regimen at doses typically used for medically-fit patients with acute myeloid leukemia may work better than reduced doses of CPX-351 in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms.
Primary Outcome
Will evaluate whether CPX-351 or cladribine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and mitoxantrone (CLAG-M), at doses typically used for medically-fit adults with AML, improve 3-month overall survival in medically-unfit adults with AML compared to attenuated dose CPX-351 as used in our previous institutional trial (32 units/m2 per dose).
Conditions Studied
Interventions
- DRUG Cladribine
- BIOLOGICAL Recombinant Granulocyte Colony-Stimulating Factor
- DRUG Cytarabine
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
- DRUG Mitoxantrone
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04195945 still lists
NCT04195945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cladribine is the first listed.
NCT04195945 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04195945 about?
NCT04195945 is a clinical study titled "CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients". This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, c...
What is the current status of trial NCT04195945?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-03-11. Estimated completion is 2027-12-31.
What conditions does trial NCT04195945 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myeloid Neoplasm.
What interventions are being tested in trial NCT04195945?
The interventions under investigation include: Cladribine (DRUG), Recombinant Granulocyte Colony-Stimulating Factor (BIOLOGICAL), Cytarabine (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG), Mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT04195945?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195945 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04195945's enrollment target sits among peer trials
60 120th of 306 higher than 180 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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