Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation in patients with an unrelated donor

• Conditions: Patients with AML, MDS, ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent a (non) myeloablative allo-SCT with an unrelated donor.; MedDRA version: 14.1Level: PTClassification code 10007838Term: CD4 lymphocytesSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-002418-38-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-15
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

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

Inclusion Criteria

• Age > 18 years
• Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who are definitely planned to undergo an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ.
• Life expectation of > 3 months
• WHO performance status of 0, 1 or 2
• Written informed consent according to the rules and regulations of the Leiden University Medical Center.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Use of systemic immunosuppressive treatment (due to GVHD)
• Acute GVHD of the skin > grade 2 or progressive acute GVHD
• Progressive disease needing cytoreductive treatment
• Any concomitant disease preventing the safe administration of donor lymphocytes
• Severe psychological disturbances
• Severely limited life expectation due to diseases other than the malignancy
• Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.

Study & Design

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