Condition category
Cancer
Date applied
22/02/2006
Date assigned
31/03/2006
Last edited
31/03/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sebastian Voigt

ORCID ID

Contact details

Department of General Pediatrics
Augustenburger Platz 1
Berlin
13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GAP-Protocol

Study hypothesis

Allogeneic AdV-specific T lymphocytes (ASTL) can be generated and used therapeutically with a low risk of graft versus host disease (GVHD)

Ethics approval

Ethical approval not yet received as of 31/03/2006

Study design

Prospective, randomized, double-blind, placebo-controlled, phase III multicenter trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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%

Secondary outcome measures

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

Overall trial start date

01/07/2006

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

306

Participant 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

Recruitment start date

01/07/2006

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of General Pediatrics
Berlin
13353
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Germany)

Sponsor details

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vo 774/4-1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes