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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Hematopoietic stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00682305

TreoALL

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Single-Arm

Other group

Description:

Single-Arm

Treatment:

Procedure: Hematopoietic stem cell transplantation