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NCT02583893 · ClinicalTrials.gov registry record · Phase 2
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
A Phase 2 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT02583893 is a Phase 2 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 39 participants, below the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02583893, a Phase 2 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine \[MEC\]) in patients with acute myeloid leukemia (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve patient response. Studying samples of bone marrow from patients treated with sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and whether changes in biomarker levels can predict how well patients will respond to treatment.
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Mitoxantrone
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-10-07 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02583893
The ClinicalTrials.gov registry entry for NCT02583893 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (25% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Recurrent Adult Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT02583893 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02583893 about?
NCT02583893 is a clinical study titled "Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia". This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine \[MEC\]) in patients with acute myeloid leukemia (AML) that is likely to come back or...
What is the current status of trial NCT02583893?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2015-10-07. Estimated completion is 2023-05-17.
What conditions does trial NCT02583893 study?
This clinical trial studies the following conditions: Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia.
What interventions are being tested in trial NCT02583893?
The interventions under investigation include: Sirolimus (DRUG), Etoposide (DRUG), Cytarabine (DRUG), Mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT02583893?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02583893 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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