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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT00682305
Eligibility Criteria:
Inclusion Criteria:
* Acute lymphoblastic leukemia in first or subsequent complete remission
* Indication for allogeneic stem cell transplantation according to the actual protocol of the German Acute Lymphoblastic Leukemia Study Group
* Patient's age: 18-65 years
* HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed)
* Not eligible for total-body irradiation due to one of the following reasons:
* prior radiation of the spine \> 30 Gy
* prior radiation of the mediastinum \> 30 Gy
* severe pulmonary infection during induction chemotherapy
* DLCO \> 50%
* Patient's wishing to avoid total-body irradiation as conditioning regimen
* Patient's written informed consent
* Women and men capable of reproduction must agree to use highly effective methods of contraception until six months after treatment termination. For men: vasectomy, sexual abstinence, or partner is using hormonal IUD, implants, injectables, oral hormonal contraceptives or is surgically sterilized. For women: hormonal IUD, implants, injectables, sexual abstinence, surgical sterilization, vasectomised partner
Exclusion Criteria:
* No complete remission at time of registration
* Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
* total bilirubin, SGPT or SGOT \> 3 times upper the normal level
* Left ventricular ejection fraction \< 30%
* Creatinine clearance \< 30 ml/min
* DLCO \< 35% and/ or receiving supplementary continuous oxygen
* Positive serology HIV
* Pregnant or lactating women
* Severe florid infection
* Experienced hypersensitivity against cyclophosphamid, etoposide, or treosulfan
* Cystitis
* Obstructive renal function
* Participation in any other clinical drug trial
* Serious psychiatric or psychological disorders
* Progressive invasive fungal infection at time of registration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00682305
Study Brief:
Protocol Section:
NCT00682305