European Leukemia Trial Registry
Trial: CMPE Treosulfan + PBPCT in OMF

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Scientific Title Myeloablative conditioning of patients with myelofibrosis with myeloid metaplasia (MMM) using i.v. Treosulfan and autologous peripheral blood progenitor cell transplantation (PBPCT) with high doses of CD34+ cells
Short Title CMPE Treosulfan + PBPCT in OMF
Id KN/ELN LN_CMPEEX_2003_67
Trialgroup CMPE-Expertengruppe
Type of Trial multicentric
Phase Phase II
Disease Myeloproliferative disease(MPD) Myelofibrosis
Stage of Disease .
Category stem cell transplantation
Inclusion Criteria
  • Male or female patients ≥ 18 years of age.
  • Patients with a confirmed diagnosis of MMM
  • Patients with high-risk disease
  • SGOT (ASAT) and/or SGPT (ALAT) not more than 2.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
  • Total serum bilirubin level not more than 1.5 x the ULN at the laboratory where the analysis was performed.
  • Serum creatinine concentration not more than 1.5 x the ULN at the laboratory where the analysis was performed.
  • Patients of childbearing potential must have a negative pregnancy test prior to the initiation of mobilization conditioning chemotherapy. Male and female patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months after autologous transplantation
  • Written voluntary informed consent.
Exclusion Criteria
  • Patients receiving any other investigational agents within 28 days of day 1 of G-CSF mobilization.
  • Patients with grade 3/4 cardiac disease as defined by the New York Heart Association Criteria (Appendix 3)
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
  • Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study
  • Female patients who are either pregnant or breastfeeding. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
  • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
  • Patients with known hypersensitivity to study medication.
Age >= 18 years
Status Closed
Start of Recruitment 09.06.2003
Recruiting Countries Germany
Target Sample Size 24
Leader Frühauf, PD Dr. med., Stefan
Scientific Contact Frühauf, PD Dr. med., Stefan (Affliliation)
Contact Person

Study Physician
Buss, Dr. med., Eike
Tel: +49 (0)6221 56 2781
Fax: +49 (0)6221 56 5722

Study Centre
Opgenorth, Annette
Tel: +49 (0)6221 568006
Fax: +49 (0)6221 565791
Email: annette.opgenorth@med.uni-heidelberg.de

Study Centre
Geueke, A.-M.
Tel: +49 (0)6221 568006
Fax: +49 (0)6221 565791
Email: haem-onk_studien@med.uni-frankfurt.de

Biometrics
Benner, A.
Tel: +49 (0)6221 422390
Fax: +49 (0)6221 422397
Email: benner@dkfz-heidelber.de
Homepage: www.dkfz.de

Centre of Trial Universitätsklinikum Heidelberg
Shortprotocol Shortprotocol
Diagnostics

Cytogenetics
Institut für Humangenetik, Universität Heidelberg

Histology
Pathologisches Institut der Universität Hannover

created 07.07.2006 Anja Hellenbrecht
changed 20.03.2015 Hanna Ebert
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