Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMay 13, 2015
May 1, 2015
5.8 years
May 16, 2008
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT
1 year after SCT
Secondary Outcomes (1)
*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
Study Arms (1)
Single-Arm
OTHERSingle-Arm
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Related Publications (1)
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.
PMID: 26367236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaus Kroeger, Prof. Dr.
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 22, 2008
Study Start
March 1, 2007
Primary Completion
January 1, 2013
Study Completion
August 1, 2013
Last Updated
May 13, 2015
Record last verified: 2015-05