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NCT01101880 · ClinicalTrials.gov registry record · Phase 2
Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm
A Phase 2 study of Chronic Myelomonocytic Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT01101880: Completed Phase 2 study of Chronic Myelomonocytic Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, sponsored by University of Washington.
NCT01101880 is a Phase 2 study of Chronic Myelomonocytic Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities that has completed, run by University of Washington. The registered enrollment target is 50 participants, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (43% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101880, a Phase 2 study of Chronic Myelomonocytic Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial is studying how well giving clofarabine and cytarabine together with filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
Primary Outcome
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count reco
Conditions Studied
Interventions
- DRUG clofarabine
- BIOLOGICAL filgrastim
- DRUG cytarabine
Study Locations (3)
California
- City of Hope Medical Center - Duarte
- Stanford University - Stanford
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
What the finished NCT01101880 record still lists
NCT01101880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (43% lower).
The record links to 10 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which clofarabine is the first listed.
NCT01101880 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT01101880 about?
NCT01101880 is a clinical study titled "Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm". This phase II trial is studying how well giving clofarabine and cytarabine together with filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs used in chemotherapy, such as ...
What is the current status of trial NCT01101880?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-08. Estimated completion is 2017-07.
What conditions does trial NCT01101880 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12).
What interventions are being tested in trial NCT01101880?
The interventions under investigation include: clofarabine (DRUG), filgrastim (BIOLOGICAL), cytarabine (DRUG).
Who is sponsoring clinical trial NCT01101880?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101880 being conducted?
This trial has 3 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01101880's enrollment target sits among peer trials
50 38th of 73 higher than 31 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic 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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