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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Hematopoietic stem cell transplantation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-Arm

Arm Description

Single-Arm

Outcomes

Primary Outcome Measures

Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT

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

Full Information

First Posted
May 16, 2008
Last Updated
May 12, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00682305
Brief Title
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Acute Lymphoblastic Leukemia, Hematopoeitic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Other
Arm Description
Single-Arm
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic stem cell transplantation
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
*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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26367236
Citation
Kroger N, Bornhauser M, Stelljes M, Pichlmeier U, Trenschel R, Schmid C, Arnold R, Martin H, Heinzelmann M, Wolschke C, Meyer RG, Bethge W, Kobbe G, Ayuk F, Gokbuget N, Holzer D, Zander A, Beelen D. Allogeneic stem cell transplantation after conditioning with treosulfan, etoposide and cyclophosphamide for patients with ALL: a phase II-study on behalf of the German Cooperative Transplant Study Group and ALL Study Group (GMALL). Bone Marrow Transplant. 2015 Dec;50(12):1503-7. doi: 10.1038/bmt.2015.202. Epub 2015 Sep 14.
Results Reference
derived

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

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