HOVON HO71

Archived

Main info

Identifier:
HOVON 71 ALL
Sponsor:
HOVON
Included patients:
60
Active sites:
21
(of 21)
Title:

Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemotherapy.

Timeline

Scheduled
Actual
2005
21 Oct
Activated
2008
03 Jan
CloseoutInProgressLastPtOutActualStart
2018
03 Jan
Archived

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Age 40 - 70 years inclusive;
  • Primary previously untreated ALL;
  • WHO performance status 0, 1, or 2 (appendix C);
  • Negative pregnancy test at inclusion if applicable;
  • Written informed consent.
Exclusion Criteria:
  • Mature B-cell ALL;
  • Acute undifferentiated leukemia (AUL);
  • Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
  • Severe pulmonary dysfunction (CTCAE grade III-IV);
  • Severe neurological or psychiatric disease;
  • Significant hepatic dysfunction (serum bilirubin or transaminases >=3 times normal level) except when caused by leukemic infiltration;
  • Significant renal dysfunction (serum creatinin >=3 times normal level after rehydration and correction of hyperuricemia);
  • History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
  • History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent);
  • Active, uncontrolled infections;
  • Patients known to be HIV-positive;
  • Patient is a lactating woman;
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Participating Sites

Site
21 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
15
NL-Rotterdam-ERASMUSMC
7
NL-Maastricht-MUMC
5
NL-Utrecht-UMCUTRECHT
5
NL-Nijmegen-RADBOUDUMC
4
NL-Groningen-UMCG
4
NL-Amsterdam-AMC
4
NL-Amsterdam-VUMC
3
NL-Enschede-MST
2
NL-Zwolle-ISALA
2
NL-Arnhem-RIJNSTATE
2
NL-Leiden-LUMC
2
BE-Antwerpen-ZNASTUIVENBERG
1
NL-Den Haag-HAGA
1
BE-Leuven-UZLEUVEN
1
BE-Roeselare-AZDELTA
1
NL-Amersfoort-MEANDERMC
1
NL-Nieuwegein-ANTONIUS
NL-Amsterdam-OLVG
BE-Brugge-AZBRUGGE
NL-Hilversum-TERGOOI
= Active hospitals
= Inactive hospitals

Participating Parties

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