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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: Completed 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined by change in phosphorylated ribosomal protein S6 (pS6) positive blasts, measured as the % reduction in pS6 positive blasts from baseline to day 4. Biochemical response will be described by mean, median, standard deviation, range and coefficient of variation. The association between biochemical response and clinical response will be tested by Fisher's exact test.
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 |
What the finished NCT02583893 record still lists
NCT02583893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 52-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (25% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02583893's enrollment target sits among peer trials
39 9th of 19 higher than 11 of 19 other Recurrent Adult Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult 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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