HOVON HO61

Archived

Main info

Identifier:
HOVON 61 NHL
Sponsor:
HOVON
Active sites:
6
(of 6)
Title:

Supportive care in chemotherapy-related anemia in elderly non-Hodgkin's lymphoma: Darbepoetin alfa (Ara-nesp) versus red blood cell transfusion.

Timeline

Scheduled
Actual
2004
17 Nov
Activated
2020
23 Oct
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Registration in the HOVON 46 NHL trial;
  • Hb levels <= 6.2 mmol/l (<= 10 g/dl);
  • Completion of baseline quality of life questionnaire;
  • Written informed consent
Exclusion Criteria:
  • Hypersensitivity to components of darbepoetin;
  • Treatment with epoetin or epoetin-related drugs within 4 weeks before registration in the HOVON 46 NHL trial;
  • Red cell transfusion after registration in the HOVON 46 NHL trial and within 4 weeks before randomization;
  • Correctable anemia not related to chemotherapy or bone-marrow infiltration such as deficiencies (iron, vit. B12, folic acid, autoimmune hemolysis);
  • Anemia due to other hematological diseases such as myelodysplastic syndromes or myeloproliferative syndromes;
  • Uncontrolled hypertension.

Participating Sites

Site
6 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
NL-Rotterdam-ERASMUSMC
NL-Den Haag-HAGA
NL-Nieuwegein-ANTONIUS
NL-Utrecht-UMCUTRECHT
NL-Amsterdam-VUMC
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up