At a glance
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A Randomized Study of Once Daily Fludarabine-Clofarabine Versus Fludarabine Alone Combined With Intervenous Busulfan Followed by Allogeneic Hemopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
In Brief
A Phase 3 clinical trial evaluating Fludarabine, Clofarabine, and 5 other interventions for Disorder Related to Bone Marrow Transplantation and 2 related conditions. Completed, enrolled 256 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be studied.
Study Details
Timeline
Interventions
Flu + Bu Group: 40 mg/m2 by vein on Days -6 through -3. Flu +Clo + Bu Group: 10 mg/m2 by vein on Days -6 through -3.
30 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, and infused on Days -6 through -3.
Busulfan systemic exposure dose of 6000 µMol-min in normal saline over three (3) hours by vein every twenty-four (24) hours for four (4) consecutive days (days -6 to -3), starting immediately after the completion of Clofarabine. The dose on day -6 to -3 based on pharmacokinetic analysis of target AUC of 4,000 µMol-min ± 5% for 61-70 years of age (without Pharmacokinetics alternate dose 130 mg/m2).
Both groups who receive a graft from an unrelated donor: 0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.0 mg/kg on day -1. On day -3, administered after the chemotherapy is complete.
Cryopreserved bone marrow or peripheral blood progenitor cells infused on day 0.
Starting dose: 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.