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 States27 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 range18 Years
SexALL
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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 …
What they're measuring
1
Participants With Hematologic Response
Timeframe: From Start of the Study up to Study Termination (approximately up to 18 Months).