Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation
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 lymphoblastic leukemia who are not eligible for a TBI-containing regimen.
Interventions
PROCEDUREHematopoietic stem cell transplantation
conditioning regimen: * day -7: 12g/m\^2 Treosulfan * day -6: 12g/m\^2 Treosulfan * day -5: 12g/m\^2 Treosulfan * day -4: 30mg/kg BW Etoposide * day -3: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide * day -2: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide * day -1: 20mg/kg ATG Fresenius (OPTIONAL) * day 0: SCT
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT | 1 year after SCT |
Secondary
| Measure | Time frame |
|---|---|
| *Incidence of aGvHD on day +100/ cGvHD at 1 and 2 yrs after SCT/ relapse at 2 yrs after SCT *Toxicity *Disease-free survival at 2 yrs after SCT *overall survival at 2 yrs. after SCT | 2 years after transplantation |
Countries
Germany
Outcome results
None listed