Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Le… (NCT01629082) | Clinical Trial Compass
CompletedPhase 1
Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
United States4 participantsStarted 2012-06-06
Plain-language summary
Background:
* Several types of blood cancer are associated with poor outcomes including high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for standard treatments. New types of treatment are needed for these cancers.
* Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the body. The second can alter blood supply to abnormal cells or affect how the immune system attacks these cells. These drugs have been previously tested as treatments for MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and AML. Researchers want to see if these drugs are safe and effective for these types of cancer.
Objectives:
\- To test the safety and effectiveness of clofarabine and lenalidomide for people with high-risk MDS, CMML, and AML.
Eligibility:
* Individuals at least 18 years of age who have high-risk MDS, CMML, and AML.
* Participants must not be candidates for standard treatments.
Design:
* Participants will be screened with a physical exam and medical history. Blood and bone marrow samples will be collected.
* Participants will have 5 days of treatment with clofarabine. It will be given through a vein during an inpatient hospital stay. If there are no serious side effects after the infusion, participants will continue treatment as outpatients.
* After 28 days, participants will have a bone marrow biopsy to check their response to treatment.
* After the biopsy, participants will start lenalidomide treatment. Half of the participants will take the drug for 28 days (one treatment cycle). The other half will take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor treatment.
* If there are no serious side effects and the disease does not become worse, participants may keep taking lenalidomide at lower doses for up to 12 more cycles.
Who can participate
Age range
18 Years – 99 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:
* Age greater than or equal to 18 years old
* Unequivocal diagnosis of MDS (including chronic myelomonocytic leukemia- CMML) according to WHO criteria with IPSS risk categorization for MDS subjects of intermediate-2 to high confirmed by bone marrow evaluation within 30 days prior to study enrollment
OR
Unequivocal diagnosis of AML according to WHO criteria to include secondary and relapsed or refractory disease confirmed by bone marrow evaluation within 30 days prior to study enrollment
* ECOG Performance Status less than or equal to 2
* Must have failed at least one prior therapy before study enrollment
* Ability to comprehend the investigational nature of the study and provide informed consent
* All study participants must be registered into the mandatory RevAssistRevlimid REMS program, and be willing and able to comply with the requirements of RevAssistRevlimid REMS .
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssistRevlimid REMS ) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also ag…
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
Identification of the maximum tolerated dose.
Trial details
NCT IDNCT01629082
SponsorNational Heart, Lung, and Blood Institute (NHLBI)