Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00117702
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between 18 and 70 years of age
* Planned allogeneic stem cell transplantation either from a related or an unrelated donor
* Written informed consent
Exclusion Criteria:
* Previous stem cell transplantation
* Use of antibody Campath (anti CD-52) or ATG during the conditioning
* In vitro T-cell depleted graft
* Known hypersensitivity to everolimus or other constituents of the study medication
* Symptomatic infectious disease
* Hepatic disease (ASAT \> 2 x ULN)
* Renal insufficiency (creatinine \> 2 x ULN)
* HIV infection
* Life expectancy \< 3 months
* Severe lung disease (FEV1 \< 50% of the normal value)
* Severe psychiatric disorder
* Subjects unlikely to comply with the requirements of the protocol
* Known or current alcohol, medication or drug abuse
* Pregnancy or lactation
* Women of child-bearing potential without reliable contraception unless they meet the following criteria: postmenopausal (12 months of natural amenorrhea);postoperation status (6 weeks after surgical bilateral oophorectomy with or without hysterectomy);use of highly effective birth control method (defined as one which results in a low failure rate i.e. less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomized partner)
* Men that do not use one of the following methods for prevention of conception:sexual abstinence; condom; vasectomy
* Participation of the subject in another clinical trial within the last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00117702
Study Brief:
Protocol Section:
NCT00117702