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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: Recruiting Phase 2 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Disease-free survival (DFS) defined as the time interval from treatment start until clinically significant disease progression or death, whichever occurred first. Participants followed for survival every 6 to 12 months after completion of active treatment. Study continuously monitored for primary endpoint, DFS using the method of Thall, Wooten, and Tannir.
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 |
What NCT01515527 shows while recruiting
NCT01515527 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01515527's enrollment target sits among peer trials
160 46th of 233 higher than 188 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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