In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after allo-SCT, will be evaluated
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
Andere hematologische maligniteiten (multipel myeloom, lymfoom)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.
Secondary outcome
• Chimerism of circulating lymphocytes.
• Transplantation related complications between 3 and 12 months after the
transplantation (CMV disease or CMV reactivation needing systemic treatment,
EBV reactivation needing systemic treatment, VZV infection, other infections
for which hospitalization, GVHD needing systemic treatment, auto-immune
disorders needing systemic treatment).
Background summary
Allo-SCT provides potentially curative therapy for patients with a variety of
hematologic malignancies. However, acute GVHD and its treatment are major
causes of transplant-related morbidity and mortality. The most efficient method
for prevention of GVHD consists of T-cell depletion of the graft. Allo-SCT
regimens using the CD52 antibody alemtuzumab for T-cell depletion demonstrate
efficient engraftment and reduced acute GVHD. However, these protocols
substantially impair post-transplant antiviral and antitumor immunity. Patients
show a poor immune reconstitution, particularly with slow recovery of the CD4+
T-cell subset.
Study objective
In this phase II study, the toxicity and treatment effects of early donor
derived CD4+ lymphocyte infusion, three months after allo-SCT, will be
evaluated
Study design
Randomized open label single centre intervention study
Intervention
Infusion of CD4+ lymphocytes at three months after the transplantation
Study burden and risks
Participating patients will visit the outpatient clinic once every two weeks
for physical examination and blood sampling, which is at this moment the
standard care for patients during the first six months after allo-SCT at our
institution. The total amount of blood which will be taken for study purposes
will be maximally 250 cc in a three months period. One extra bone marrow
examination will be performed (six weeks after CD4+ infusion). The risk of CD4+
donor lymphocyte infusion is acute GVHD, as is seen in patients receiving total
donor lymphocyte infusion after allo-SCT. Potential benefit is a faster immune
reconstitution. If chimerism converts to donor, further unmodified DLIs could
be omitted.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
• Age > 18 years
• Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who underwent an allo-SCT with an unrelated 10/10 matched donor (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.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002418-38-NL |
| CCMO | NL40884.000.12 |