Acute Myeloid Leukemia Clinical Trial
Official title:
Clofarabine Salvage Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia
In relapsed or refractory AML allogeneic HCT is considered to be the only treatment by which
long-term disease-free survival can be achieved. Despite this favorable prospect, even in
younger patients with relapsed AML only about 40% of the patients reach allogeneic HCT. A
number of factors contribute to this low rate of transplantation, among them moderate
activity of the salvage regimens and accumulating toxicities which prevent from
transplantation; Prospective clinical trials in this indication usually focus either on the
rate of CR achieved after a defined number of cycles of salvage therapy or on
transplantation modalities. The consequent integration of salvage therapy into a transplant
strategy accounting for the time-dependent process of donor search has not been studied so
far.
The objective of this study is to evaluate the safety and efficacy of clofarabine salvage
therapy prior to allogeneic HCT.
All patients are scheduled for at least one cycle of induction therapy with CLARA. CLARA
contains clofarabine 40 mg/m2 (1 hr infusion) days 1-5 followed 3 hours after the end of
infusion by intermediate dose cytarabine 1 g/m2 (2 hrs infusion) days 1-5. Patients with
moderate early response (reduced marrow blast count but ≥10% at day 15) or patients with
progressive disease during delayed hematologic recovery (beyond day 42) may receive
re-induction therapy similar to the first cycle induction therapy.
Study treatment comprises up to two cycles of induction therapy and one to two cycles of
consolidation chemotherapy for patients without a donor. Consolidation therapy is reduced by
25% and consists of clofarabine 40 mg/m2 (1 hr infusion) days 1-4 followed 3 hours after the
end of infusion by intermediate dose cytarabine 1 g/m2 (2 hrs infusion) days 1-4.
Patients for whom a donor can be identified may proceed to allogeneic HCT after CLARA I
adopting the concept of allogeneic HCT in aplasia. Patients for whom donor search is more
time consuming should proceed to allogeneic HCT once a donor has been identified.
Patients who have achieved a response after the last cycle of CLARA will receive clofarabine
as part of the conditioning regimen. Clofarabine and melphalan may only be given as
conditioning therapy to patients with HLA-compatible donors with a maximum of one mismatch
refering to the HLA-loci A, -B, -C and -DRB1. Conditioning therapy then contains clofarabine
30 mg/m2 (1 hr IV infusion) days -6 to -3 and melphalan 140 mg/m2 (1 hour IV infusion) on
day -2.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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