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NCT01515527 · ClinicalTrials.gov registry record · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT01515527 is a Phase 2 study of Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 160 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01515527, a Phase 2 study of Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.
Conditions Studied
Interventions
- DRUG Cladribine
- DRUG Decitabine
- DRUG Cytarabine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2012-02-07 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01515527
The ClinicalTrials.gov registry entry for NCT01515527 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (67% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cladribine is the first listed.
NCT01515527 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01515527 about?
NCT01515527 is a clinical study titled "Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cel...
What is the current status of trial NCT01515527?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2012-02-07. Estimated completion is 2028-02-01.
What conditions does trial NCT01515527 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01515527?
The interventions under investigation include: Cladribine (DRUG), Decitabine (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT01515527?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01515527 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.