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Phase I/II Clinical Trial of Arsenic Trioxide in Myelodysplastic Syndromes Patients

This multicenter study evaluates the efficacy and safety of arsenic trioxide (ATO) in patients with myelodysplastic syndromes (MDS). The primary objective focuses on achieving major hematologic improvement for lower-risk MDS patients and complete or partial remission in higher-risk patients. Secondary objectives include assessing durability of responses, survival duration, quality of life during therapy, ATO toxicity profile, and pharmacokinetics. Eligibility criteria include a confirmed MDS diagnosis and specific clinical parameters. Results indicate a global response rate of 27%.

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Phase I/II Clinical Trial of Arsenic Trioxide in Myelodysplastic Syndromes Patients

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  1. Phase I/II Multicenter Study of Arsenic Trioxide in Patients with Myelodysplastic SyndromesProtocole CTI 1061Analyse Mars 2004 Rouen, Juin 2004

  2. Dose regimen Week 3 Week 2 Week 16+ Week 1 Week 4 ATO 0.30 mg/kg x 5 days and 0.25 mg/kg twice a week for at least 15 weeks

  3. Phase I/II Multicenter Study of Arsenic Trioxide in Patients with Myelodysplastic Syndromes Primary Objective - lower-risk MDS: % of patients who will achieve major hematologic improvement - higher-risk MDS: % of patients who will achieve complete (CR) or partial remission (PR) • Secondary Objective • Durability of any responses observed • Duration of overall and progression-free survival • Quality of life (QOL) during therapy • Toxicity profile of ATO in this patient population • Pharmacokinetic profile of ATO with this dosing schedule

  4. Eligibility criteria • Confirmed diagnosis of MDS by standard FAB criteria: RA, RARS, RAEB, RAEB-t, or CMML • Age 18 years; life expectancy 3 months • Serum creatinine 1.5 x ULN; bilirubin, SGPT and SGOT 2.5 x ULN • QTc interval <460 msec with serum K+ >4.0 mEq/L and Mg2+ >1.8 mg/dL • No growth factors or treatment with cytotoxic or experimental agents within 30 days before study dosing

  5. Safety

  6. Patients Characteristics

  7. Cytogenetics

  8. Response by IPSS Risk Category IPSS Risk Category Lineage (baseline High Risk Patients (n = Low Risk Patients (n = 39) 62) values) Minor Major Minor Major response response response response Erythroid lineage 7 (includin g 3 4 2 response (Hgb 1 CR) <11g/dL) Platelet lineage 1 1 1 6 response 9 (<100x10 /L) Neutrophil lineage 0 0 0 7 response 9 (<1.5x10 /L) Lineage responses (some pts had 4 5 3 20 responses in more than one lineage) All: 9/39 (23%) Al l: 18/62 (29%) Total PATIENTS with response Major: 5/39 (13%) Major: 16/62 (26%) All: 27/101 (27%) Total response rate Major: 21/101 (21%) ³ *Responses by modified IWG criteria: response must be maintained 56 days. Efficacy assessment

  9. OR= 10% (RA/RARS) versus 30% (RAEB/RAEB-t), p<0.05

  10. Conclusions • Étude arrêtée avec objectif de recrutement atteint (n=110) • Taux de réponse global: 27% • 21% de réponses majeures, • 50% des répondeurs obtiennent indépendance transfusionnelle • Taux de réponse > quand excès de blastes • Études d’arsenic en combinaison sont à faire

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