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Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS)


Phase 2
18 Years
60 Years
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS)


Inclusion Criteria:



1. Patients with myelodysplastic syndrome, (MDS) according to WHO classification (< 20 %
myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for
allogeneic transplantation

2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor
(MUD) HLA-identity defined by the following markers: HLA-A, -B, -DRB1, DQB1.

3. Target graft size (unmanipulated) bone marrow: 2 to 10 x 106 CD34+ cells/kg BW
recipient or at least 2 x 108 nucleated cells /kg BW or peripheral blood: 4 to 10 x
106 CD34+ cells/kg BW recipient

4. Age > 18 and < 60 years

5. Karnofsky Index > 80 %

6. Adequate contraception in female patients of child-bearing potential

7. Written informed consent

Exclusion Criteria:

1. 'Secondary' or therapy-related MDS with known history of exposure to cytotoxic
alkylating drugs and/or radiation therapy

2. Previous AML-induction therapy with more than two courses (e.g. in case of blast
excess)

3. Previous allogeneic transplantation

4. Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or
cardiac function)

5. Known and manifested malignant involvement of the CNS

6. Active infectious disease

7. HIV- positivity or active hepatitis infection

8. Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper
normal limit)

9. Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x
upper normal limit).

10. Pleural effusion or ascites > 1.0 L

11. Pregnancy or lactation

12. Known hypersensitivity to treosulfan and/or fludarabine

13. Participation in another experimental drug trial within 4 weeks before study

14. Non-co-operative behaviour or non-compliance

15. Psychiatric diseases or conditions that might impair the ability to give informed
consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: Evaluation of engraftment

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Tapani Ruutu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Biomedicum Helsinki 2 C, POB 705, Turkholmankatu 8 C, FIN-00029 HUS Helsinki, Finland

Authority:

Finland: Finnish Medicines Agency

Study ID:

MC-FludT.8/MDS

NCT ID:

NCT01062490

Start Date:

November 2004

Completion Date:

October 2009

Related Keywords:

  • Myelodysplastic Syndrome
  • Treosulfan
  • MDS
  • allogeneic stem cell transplantation
  • leukemia
  • Conditioning
  • Myelodysplastic Syndromes
  • Preleukemia

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