Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-R… (NCT02583893) | Clinical Trial Compass
CompletedPhase 2
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
United States39 participantsStarted 2015-10-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:
. Primary refractory non-M3 AML
. Relapsed non-M3 AML
. Previously untreated non-M3 AML age \>60 with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBFβ;MYH11\] by cytogenetics, FISH, or RT-PCR
. Previously untreated secondary AML (from antecedent hematologic malignancy or following therapy with radiation or chemotherapy for another disease) with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBFβ;MYH11\] by cytogenetics, FISH, or RT-PCR
. Subjects must be ≥ 18 years of age.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biochemical Response
Timeframe: Baseline to day 4
2
Clinical Response
Timeframe: Day 45
Trial details
NCT IDNCT02583893
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Subjects must have an ECOG performance status of 2 or less (see Appendix1).
. Subjects must have a life expectancy of at least 4 weeks.
Exclusion criteria
. Subjects with FAB M3 (t (15; 17) (q22; q21) \[PML-RARα\]) are not eligible.
. Subjects must not be receiving any chemotherapy agents (except Hydroxyurea).
. Subjects must not be receiving growth factors, except for erythropoietin.
. Subjects with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible.
. Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.