Main info

Identifier:

HOVON 60 MDS SAKK 3399

Sponsor:

HOVON

Included patients:

88

Active sites:

4

(of 3)

Title:

Antithymocyte globulin (ATG) and cyclosporine (CSA) in high risk myelodysplastic syndrome (MDS): a randomized trial comparing ATG + CSA with best supportive care.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Documented MDS
• Patients in any of the following groups:

a. Hypoplastic MDS
b. MDS subtype RA (refractory anemia)
c. MDS subtype RAS (refractory anemia with sideroblasts)
d. MDS subtype RAEB (refractory anemia with excess of blasts) with 10-20% blasts in bone marrow and patient unwilling or not eligible to participate in the HOVON 42 or 43 study

• Transfusion dependence of less than 24 months duration, defined as any of the following conditions:

a. Packed red cells transfusion > 2 units per month for a period of >= 2 months
b. Untransfused hemoglobin level <= 8 g/dl
c. Platelet transfusion > 1 unit per 2 weeks for a period of > 1 month
d. Untransfused platelet count <= 20x10^9/l
e. Neutrophils < 0.5x109/l

• Age > 18 years
• ECOG/SAKK performance status <= 2
• Written informed consent

Exclusion Criteria:

• MDS types CMMoL (chronic myelo-monocytic leukemia), RAEBt (refractory anemia with excess blasts in transformation)
• Patients scheduled for bone marrow transplant
• History of other hemato-oncological disease except for non melanoma skin cancer and adequately treated in situ carcinoma of the cervix
• Prior chemotherapy or radiotherapy
• Serum creatinine or bilirubin > 2.5 x upper limit of normal
• History of heart failure, or clinically relevant cardiac arrhythmia
• History of allergy to horse proteins, anaphylactic reactions to animal proteins, or history of serum sickness
• Female patients with stablished pregnancy, or of childbearing age not practicing adequate contraceptive
• Positive HIV serology
• Active chronic hepatitis B or C
• Active uncontrolled infection

Participating Sites

= Active hospitals

= Inactive hospitals