Status:
COMPLETED
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The present study is a multicenter, prospective phase II-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblasti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00682305
Start Date
March 1 2007
End Date
August 1 2013
Last Update
May 13 2015
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246