EUCTR2008-000664-16-IT
Active, not recruiting
Phase 1
Clinical phase II trial to evaluate the safety and efficacyof treosulfan combined with cytarabine and fludarabine prior to autologous haematopoietic stem cell transplantation in elderly patients withAcute Myeloid Leukemia or Myelodysplastic Syndrome. - ND
OSPEDALE S. RAFFAELE0 sites15 target enrollmentFebruary 20, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- elderly patients withAcute Myeloid Leukemia or Myelodysplastic Syndrome
- Sponsor
- OSPEDALE S. RAFFAELE
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with de novo or secondary acute myeloid leukemia or with Int 2 or High risk myelodysplastic syndrome, according to IPSS.
- •2\.Patients unable or unfit to receive an hematopoietic stem cell transplantation from an HLA\-identical related or unrelated, or
- •HLA\-haploidentical related donor.
- •3\.Hematologic complete remission after 1 or 2 cycles of induction standard chemotherapy.
- •4\.Successful collection of autologous peripheral blood hematopoietic stem cells: ≥ 5\.0x10e6 /kg patient BW.
- •5\.Age ≥ 65 years.
- •6\.Performance Status 0\-2 ECOG, 60\-100% Karnofsky.
- •7\.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.Diagnosis of AML M3\.
- •2\.Second concomitant malignancies
- •3\.Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function)
- •4\.Known and manifested malignant involvement of the CNS
- •5\.Active infectious disease
- •6\.HIV\- positivity or active hepatitis infection
- •7\.Impaired liver function (bilirubin \> 1\.5 x upper normal limit; transaminases \> 3\.0 x upper normal limit)
- •8\.Impaired renal function (creatinine\-clearance \< 60 ml/min; serum creatinine \> 1\.5 x upper normal limit).
- •9\.Pleural effusion or ascites \> 1\.0 L
- •10\.Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine
Outcomes
Primary Outcomes
Not specified
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