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

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Procedure: Hematopoietic stem cell transplantation

• Registration Number: NCT00682305
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2013-01
• Study Completion: 2013-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	Hematopoietic stem cell transplantation	Single-Arm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
*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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany