A phase I/ II studyEfficacy and safety of alpha/beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI) - iDLI

• Conditions: Patients with high risk acute leukemia / MDS or relapse acute leukemia /MDS; MedDRA version: 12.1Level: LLTClassification code 10066481Term: Hematological malignancy

• Registration Number: EUCTR2010-021221-12-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

4.1Inclusion criteria
? Age 18-65 years
? Meeting the criteria for a allo-SCT and high risk disease *
(see below)
? WHO performance status = 2
•Written informed consent

*High risk disease as defined by:
? AML with monosomal karyotype, abnormal 3q26, t(9;22) EVI-1-expression, or complex karyotype in first CR
•No CR after first induction cycle chemotherapy
? Relapsed AML (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR
? MDS with complex karyotype or -7, transfusion dependent or neutropenic with < 10% blasts or in CR after induction therapy.
• ALL with t(9;22), t(4;11), and other 11q23 abnormalities, and hypodiploidy; complex abnormalities (= 5), excluding hyperdiploidy; high WBC at diagnosis (B-ALL > 30x109/l, T-ALL > 100x109/l) in first CR, or no CR after first induction but in CR after rescue chemotherapy
? Relapsed ALL (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

4.2Exclusion criteria
? Relapse of allo-SCT within 6 months after allo-SCT
? Relapse acute promyelocyten leukemia
? Bilirubin and/or transaminases > 2.5 x normal value
? Creatinine clearance < 40 ml/min
? Cardiac dysfunction as defined by:
Unstable angina
Unstable cardiac arrhythmias
? Active, uncontrolled infection
? HIV positivity

Study & Design

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