HOVON HO71

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Main info

Identificatie:
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 okt.
Activated
2008
03 jan.
Closeout in Progress
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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