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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm | Other | Single-Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematopoietic stem cell transplantation | Procedure | conditioning regimen:
|
| 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 |
| 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 |
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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:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaus Kroeger, Prof. Dr. | University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26367236 | Derived | Kroger N, Bornhauser M, Stelljes M, Pichlmeier U, Trenschel R, Schmid C, Arnold R, Martin H, Heinzelmann M, Wolschke C, Meyer RG, Bethge W, Kobbe G, Ayuk F, Gokbuget N, Holzer D, Zander A, Beelen D. Allogeneic stem cell transplantation after conditioning with treosulfan, etoposide and cyclophosphamide for patients with ALL: a phase II-study on behalf of the German Cooperative Transplant Study Group and ALL Study Group (GMALL). Bone Marrow Transplant. 2015 Dec;50(12):1503-7. doi: 10.1038/bmt.2015.202. Epub 2015 Sep 14. |
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|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D018380 | Hematopoietic Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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