Allogeneic Stem Cell Transplantation With Treosulfan, VP-16 and Cyclophosphamide for Patients With Acute Lymphoblastic Leukemia (ALL) Not Eligible for TBI-Containing Conditioning Regimen: A Phase II-Study
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