Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Procedure: Hematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Arm<br>Single-Arm | Procedure: Hematopoietic stem cell transplantation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation