Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Acce… (NCT00449761) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
United States, Germany27 participantsStarted 2007-02-23
Plain-language summary
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
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:
* Male or female patients aged ≥ 18 years old
* Diagnosis of Philadelphia chromosome positive accelerated or blast phase chronic myeloid leukemia defined as:
Accelerated phase - the presence of at least one of the following:
* ≥15% but \<30% blasts in blood or bone marrow
* ≥30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that \<30% blasts present in bone marrow)
* ≥ 20% basophiles in the peripheral blood
* Thrombocytopenia \<100 X 109 /L unrelated to sole therapy
Blast phase (blast crisis) - the presence of one of the following:
* ≥ 30% blasts in the blood, in bone marrow or both
* Extramedullary infiltrates of leukemic cells other than liver or spleen involvement
* Prior treatment with at least two a fusion gene of the BCR and ABL genes (BCR-ABL) tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib) and demonstrated resistance to the most recent kinase inhibitor therapy. Resistance to a BCR-ABL tyrosine kinase inhibitors (TKI) for this study was defined as:
* Progression from chronic phase to either accelerated phase or blast crisis
* Progression from accelerated phase to blast crisis
* No hematologic response (defined as not achieving complete hematologic response (CHR), no evidence of leukemia (NEL) or return to chronic phase (RTC)) within 3 months of starting therapy
* Increasing blast counts in peripheral blood of increasing marrow leukemic infiltrate (MLI, the percent marrow blasts multiplied …
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
Participants With Hematologic Response
Timeframe: From Start of the Study up to Study Termination (approximately up to 18 Months).