Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid… (NCT00775593) | Clinical Trial Compass
CompletedPhase 2
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Italy60 participantsStarted 2008-12
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
Who can participate
Age range
60 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.
DISEASE CHARACTERISTICS:
* Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
* At least 20% of blasts in the bone marrow
* AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
* No acute promyelocytic leukemia
* No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
* No active CNS leukemia
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy ≥ 4 weeks
* Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
* AST and ALT ≤ 2.5 times ULN\*
* Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min
* No active uncontrolled systemic infection
* No concurrent active malignancy
* No HIV positivity
* No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior myelosuppressive chemotherapy
* At least 48 hours since prior hydroxyurea
* No prior clofarabine or temsirolimus
* No prior allogeneic stem cell transplantation
* No investigational drug within the past 30 days
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
Complete Response Rate
Timeframe: At 2 years from study entry
Trial details
NCT IDNCT00775593
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto