HOVON HO30 AML

Archived

Main info

Identifier:
HO30 AML
Sponsor:
HOVON
Active sites:
18
(of 1)
Title:

Addition of Cyclosporin A to the Combination of Mitoxantrone and Etoposide to Overcome Resistance to Chemotherapy in Refractory Acute Myeloid Leukemia: A Randomized Phase II Study.

Timeline

Scheduled
Actual
1995
15 Jan
Activated
2005
15 Jan
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Newly diagnosed adult AML patients in sufficiently good condition who did not attain CR after standardized chemotherapy courses with idarubicin plus Ara-C and AMSA plus Ara-C respectively (HOVON 29).
  • Adult patients with AML in first or subsequent relapse after a previously attained CR.
Exclusion Criteria:
  • AML patients not fulfilling the above inclusion criteria.
  • Patients with myelodysplasia.
  • Severe cardiac, pulmonary, neurologic or metabolic disease.
  • Suboptimal kidney function.
  • Uncontrolled hypertension.
  • Liver function abnormalities.
  • Severe infection not controllable with adequate antimicrobial therapy.
  • Serological positivity for HIV.
  • Concomitant malignancy except non-melanomatous skin tumors and carcinoma in situ of the cervix uteri.
  • Pregnancy.
  • Known intolerance for one of the study drugs.
  • Refusal of the patient.

Participating Sites

Site
18 results
Order by
Accrual rate
Activation date
BE-Bruxelles-STLUC
CH-St. Gallen-KSSG
NL-Hilversum-TERGOOI
CH-Basel-USB
CH-Bern-INSEL
NL-Amsterdam-VUMC
NL-Utrecht-UMCUTRECHT
NL-Groningen-UMCG
NL-Nieuwegein-ANTONIUS
NL-Amersfoort-MEANDERMC
NL-Maastricht-MUMC
NL-Zwolle-ISALA
NL-Den Haag-HAGA
NL-Rotterdam-ERASMUSMC
NL-Rotterdam-EMCDANIEL
NL-Amsterdam-AMC
BE-Leuven-UZLEUVEN
CH-Zürich-USZ
= Active hospitals
= Inactive hospitals

Participating Parties

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