HOVON HO60

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Main info

Identificatie:
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

Scheduled
Actual
2015
13 okt.
Archived
2030
13 okt.
Destruction

Flow

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

Site
3 results
Order by
Accrual rate
Activation date
NL-Enschede-MST
3
NL-Amsterdam-VUMC
3
NL-Nieuwegein-ANTONIUS
= Active hospitals
= Inactive hospitals

Participating Parties

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