Clinical trial NCT00682305: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Hematopoeitic Stem Cell Transplantation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT
timeFrame: 1 year after SCT
Secondary outcomes:
measure: *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
timeFrame: 2 years after transplantation
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.