Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantatio

Phase 1

• Conditions: Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative).

• Registration Number: EUCTR2008-001447-19-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-29
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who are scheduled to receive an allogeneic transplantation.
•Absence of any concomitant disease preventing the safe administration of donor lymphocytes
•WHO performance status of 0, 1 or 2 (see appendix)
•No pregnancy, not breast feeding
•Life expectation of > 3 months
•No severe psychological disturbances
•No HIV positivity (tested at time of alloSCT)

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Systemic immunosuppressive treatment
Progressive GVHD
GVHD of the skin > grade 2 (see appendix)
Progressive disease needing cytoreductive treatment

Study & Design

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