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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT00682305

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Procedure: Hematopoietic stem cell transplantation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Single-Arm Single-Arm	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

Arm

Intervention/Treatment

Other: Single-Arm

Single-Arm

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

Outcome Measures

Primary Outcome Measures

Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT [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 [2 years after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator: Nicolaus Kroeger, Prof. Dr., University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT00682305

Other Study ID Numbers:

TreoALL

First Posted:

May 22, 2008

Last Update Posted:

May 13, 2015

Last Verified:

May 1, 2015

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

Acute Lymphoblastic Leukemia

Hematopoeitic Stem Cell Transplantation

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Study Results

No Results Posted as of May 13, 2015