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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00682305
First received: May 16, 2008
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Procedure: Hematopoietic stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2 years after transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: March 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682305

Contacts
Contact: Nicolaus Kroeger, Prof. Dr. +49-40-42803-5864 nkroeger@uke.uni-hamburg.de
Contact: Marion Heinzelmann, R.N. +49-40-42803-4188 mheinzel@uke.uni-hamburg.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Nicolaus Kroeger, Prof. Dr.    +49-40-42803-5684    nkroeger@uke.uni-hamburg.de   
Contact: Marion Heinzelmann, R.N.    +49-40-42803-4188    mheinzel@uke.uni-hamburg.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Prof. Dr. N. Kroeger, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00682305     History of Changes
Other Study ID Numbers: TreoALL
Study First Received: May 16, 2008
Last Updated: May 27, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on July 22, 2014