Adoptive immunotherapy for adenovirus (AdV)-associated complications post transplantation

ISRCTN	ISRCTN14732774
DOI	https://doi.org/10.1186/ISRCTN14732774
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Germany)
Funders	German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG), Vo 774/4-1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Sebastian Voigt
Scientific

Department of General Pediatrics
Augustenburger Platz 1
Berlin
13353
Germany

Primary study design	Interventional
Study design	Prospective, randomized, double-blind, placebo-controlled, phase III multicenter trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	GAP-Protocol
Study objectives	Allogeneic AdV-specific T lymphocytes (ASTL) can be generated and used therapeutically with a low risk of graft versus host disease (GVHD)
Ethics approval(s)	Ethical approval not yet received as of 31/03/2006
Health condition(s) or problem(s) studied	Pediatric patients with ALL, AML, CML or MDS following hematopoietic stem cell transplantation
Intervention	1. Treatment group will receive ASTL as prophylaxis and cidofovir as intervention. 2. Control group will receive placebo as prophylaxis and cidofovir as intervention.
Intervention type	Other
Primary outcome measure(s)	To determine the treatment related mortality (TRM), this will come into effect if: 1. TRM exceeds 35% 2. Acute GVHD III/IV exceeds 25% 3. Chronic GVHD II exceeds 25% 4. Non-hematopoietic toxicity 3-5 (according to NCI CTEP reporting criteria) exceeds 40%
Key secondary outcome measure(s)	1. Acute and chronic GVHD assessed by standard clinical grading scheme 2. Early non-hematopoietic toxicity grade according to NCI CTEP common terminology criteria for adverse events 3. Frequency and duration of AdV reactivations
Completion date	01/07/2011

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	306
Key inclusion criteria	Pediatric patients, aged 2 to 18 years with: 1. Acute leukemias (ALL) 2. Acute myeloid leukemia (AML) 3. Chronic myeloid leukemia (CML) 4. Myelodysplastic syndromes (MDS)
Key exclusion criteria	1. Patients in relapse or progress of AML or ALL and blast crisis of CML at the time of randomization 2. All second transplants 3. AdV seronegative recipients with seronegative matched related donors (MRD) 4. Patients with severe non-hematopoietic organ toxicity grade 3-5 (according to the National Cancer Institute [NCI] and Cancer Therapy Evaluation Program [CTEP] reporting criteria) at the time of randomization
Date of first enrolment	01/07/2006
Date of final enrolment	01/07/2011

Department of General Pediatrics

Berlin
13353
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan