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NCT Number: NCT00682305

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematopoietic Stem Cell Transplantation

Procedure

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 outcomes

  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 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

    Time frame: 2 years after transplantation

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 22, 2008
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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