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

Phase 1

• Conditions: elderly patients withAcute Myeloid Leukemia or Myelodysplastic Syndrome; MedDRA version: 9.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloid

• Registration Number: EUCTR2008-000664-16-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-20
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
11.Participation in another experimental drug trial within 4 weeks before day -6
12.Non-cooperative behaviour or non-compliance
13.Psychiatric diseases or conditions that might impair the ability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Evaluation of disease free survival;Secondary Objective: -Evaluation of engraftment of autotransplant<br>-Evaluation of incidence of CTC grade 3 and 4 adverse events within day +90<br>-Evaluation of non-relapse mortality within day +90 <br>-Evaluation of non-relapse mortality at +1 year and + 2 years<br>-Evaluation of overall survival <br>-Evaluation of relapse incidence;Primary end point(s): Disease-free survival (DFS) <br>