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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-Arm

Group Type OTHER

Hematopoietic stem cell transplantation

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No