Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Hematopoietic stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation
Eligibility 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
Sites / Locations
- University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-Arm
Arm Description
Single-Arm
Outcomes
Primary Outcome Measures
Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT
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
Full Information
NCT ID
NCT00682305
First Posted
May 16, 2008
Last Updated
May 12, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT00682305
Brief Title
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Arm
Arm Type
Other
Arm Description
Single-Arm
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic stem cell transplantation
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
*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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26367236
Citation
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.
Results Reference
derived
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Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
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