The feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: a randomized phase II study. - HOVON 107 MOBILIZATIO

• Conditions: stem cell mobilization; MedDRA version: 12.1Level: LLTClassification code 10053948Term: Hematopoietic stem cell mobilization; MedDRA version: 12.1Level: LLTClassification code 10024329Term: Leukemia; MedDRA version: 12.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2010-023436-16-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Donors
• HLA identical sibling donor
• Age 18-60 years inclusive
• Hematologic parameters within normal limits
• Capable of undergoing leucapheresis: adequate venous access. Must be willing to undergo insertion of a central catheter should leucapheresis via peripheral vein be inadequate
• Willing and able to have bone marrow aspiration if there is mobilization failure
• Negative pregnancy test at study entry for women of childbearing potential
• Willing and able to use adequate contraception during the mobilization and collection period
• Written informed consent from donor

Patients
• Age 18-65 years inclusive
• Patients with a cytopathologically confirmed diagnosis of:
- De novo Acute Myeloid Leukemia according to WHO classification in first complete
remission (excluding acute promyelocytic leukemia) OR
- Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS = 1.5 in first
complete remission OR
- Therapy related AML/RAEB in first complete remission OR
- Biphenotypic leukemia in first complete remission OR
- De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission.
• WHO performance score 0,1 or 2
• Patients should have an HLA- identical sibling donor
• Life expectancy >3 months
• Negative pregnancy test at study entry for women of childbearing potential
• Willing and able to use adequate contraception
• Written informed consent from patient
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

Donors
• Monozygotic twin
• Unstable hypertension requiring more than 1 medication.
• Positive serology for hepatitis C or HbsAg
• Treatment with other investigational drugs
• HIV positivity
• Pregnant or breastfeeding female subject

Patients
• Patients who are treated with a kinase-inhibitor
• Cardiac dysfunction
• Severe pulmonary dysfunction (CTCAE grade 3-4)
• Severe neurological or psychiatric disease
• Significant hepatic dysfunction
• Significant renal dysfunction
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
• Patient known to be HIV-positive
• Pregnant or breast-feeding female patients.
• Presence of other active malignancy or a history of active malignancy during the past 5 years, other than non melanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits

Study & Design

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