What the trial was testing
The trial enrolled 105 patients with leukemia. The study was sponsored by Cyclacel Pharmaceuticals, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
About 1 in 3 elderly patients with AML lived at least a year on sapacitabine.
The Lancet. Oncology · 2012 · NCT00590187
These findings — that elderly AML patients survived a year on the best dose schedule — were published in the The Lancet. Oncology and represent the headline result of the study.
Researchers tracked outcomes across 105 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with leukemia, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you or a loved one has AML and standard treatments haven't worked or aren't an option, this pill showed promise in a mid-stage trial. The best results came from a specific dosing schedule. This treatment is not yet FDA-approved — talk to your oncologist about whether similar oral therapies or clinical trials might be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open leukemia trials
A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol.
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.