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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682305
• Other study ID #: TreoALL
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: May 12, 2015
• Start date: March 2007
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• Hematopoietic stem cell transplantation
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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT		1 year after SCT	Yes
Secondary	*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	Yes