Acute Myeloid Leukemia Clinical Trial
Official title:
Phase Ib/IIa Study of Palbociclib in MLL-rearranged Acute Leukemias AMLSG 23-14/Palbo-AL-1
Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age
limit Study drug: Palbociclib Phase Ib/IIa, open-label
- Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days
followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell
lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and
glioblastoma, this regimen will be chosen for the first dose to be evaluated in the
phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib
for the phase IIa is defined.
- Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib
part of the study is administered once daily for 21 days followed by 7 days of rest.
Based on the optimal two-stage design of Simon, 21 patients are treated in the first
stage. If results are positive, 29 additional patients will be recruited into the second
stage of the study. An efficacy of the investigational therapy will be rejected in the
first stage of 21 treated patients if two or less patients achieve complete remission
(CR), CR with incomplete blood count recovery (CRi), partial remission (PR), or
anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE during
this first stage, the trial is intended to be continued in the second stage with a total
sample size of 50 patients.
Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient
out): July 2018 The treatment duration of an individual patient is estimated to be 2-6
months, but may be unlimited in patients with sustained response ("case-by-case decision").
Observation time per patient after entry into the study (incl. treatment) is at least 12
months.
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