Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT00425477) | Clinical Trial Compass
CompletedPhase 2
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
United States26 participantsStarted 2006-11
Plain-language summary
RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia.
PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia.
Who can participate
Age range
18 Years – 120 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:
* Diagnosis (confirmed by bone marrow aspirate and/or biopsy) of 1 of the following:
* Myelodysplastic syndromes of 1 of the following cell types:
* Refractory anemia (RA) with ringed sideroblasts
* Refractory cytopenia with multilineage dysplasia (RCMD)
* RCMD and ringed sideroblasts
* RA with excess blasts-1
* RA with excess blasts-2
* Myelodysplastic syndromes, unclassified
* Chronic myelomonocytic leukemia
* Relapsed or refractory acute myeloid leukemia (AML), meeting 1 of the following criteria:
* Recurrent genetic abnormalities (11q23 \[MLL\] abnormalities)
* Multilineage dysplasia
* Therapy-related AML
* Not otherwise categorized, including any of the following:
* M0 minimally differentiated
* M1 without maturation
* M2 with maturation
* M4 myelomonocytic leukemia
* M5 monoblastic/monocytic leukemia
* M6 erythroid leukemia
* M7 megakaryoblastic leukemia
* Newly diagnosed untreated AML allowed provided patient does not qualify for or refused potentially curative intensive chemotherapeutic regimens
* No RA with 5q-syndrome
* No peripheral leukemia with blast count \> 30,000/mm³ (uncontrolled with hydroxyurea)
* Relatively stable bone marrow function for \> 7 days (i.e., no WBC doubling to \> 10,000/mm\^3)
* No acute promyelocytic leukemia
* No clinical symptoms of active CNS disease (if CNS disease is suspected, patient must have lumbar puncture with ne…
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
Clinical Response (Complete and Partial)
Timeframe: assessed after 2 cycles, up to 2 years
Trial details
NCT IDNCT00425477
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins