Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00682305
First received: May 16, 2008
Last updated: May 27, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Procedure: Hematopoietic stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:
Primary Outcome Measures:
- Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT [ Time Frame: 1 year after SCT ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- *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 [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 55 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Procedure: Hematopoietic stem cell transplantation
- 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
conditioning regimen:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682305
Contacts
| Contact: Nicolaus Kroeger, Prof. Dr. | +49-40-42803-5864 | nkroeger@uke.uni-hamburg.de |
| Contact: Marion Heinzelmann, R.N. | +49-40-42803-4188 | mheinzel@uke.uni-hamburg.de |
Locations
| Germany | |
| University Medical Center Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Nicolaus Kroeger, Prof. Dr. +49-40-42803-5684 nkroeger@uke.uni-hamburg.de | |
| Contact: Marion Heinzelmann, R.N. +49-40-42803-4188 mheinzel@uke.uni-hamburg.de | |
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
More Information
No publications provided
| Responsible Party: | Prof. Dr. N. Kroeger, Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00682305 History of Changes |
| Other Study ID Numbers: | TreoALL |
| Study First Received: | May 16, 2008 |
| Last Updated: | May 27, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Germany: Paul-Ehrlich-Institut |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
|
Acute Lymphoblastic Leukemia Hematopoeitic Stem Cell Transplantation |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Treosulfan |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on June 18, 2013