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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00682305
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 : March 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  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 [ Time Frame: 2 years after transplantation ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00682305

University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00682305     History of Changes
Other Study ID Numbers: TreoALL
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Acute Lymphoblastic Leukemia
Hematopoeitic Stem Cell Transplantation

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists