HOVON HO117 ALL

Closed

Main info

Identifier:
HO117 ALL / UKALL 60+
Sponsor:
HOVON
Working group party:
Leukemia
Age:
>= 55
Stage:
1st Line
Echelon:
Limited Site Selection
Included patients:
1
(of 48)
Active sites:
5
(of 7)
Title:

A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia

Timeline

Scheduled
Actual
2012
20 Mar
Opportunity
2012
15 Apr
EC Approval
2012
30 Apr
First Site
2012
30 Apr
FPI
2015
03 Aug
EC Approval
2016
03 Feb
First Site
2016
03 Feb
FPI
2017
30 Apr
Endpoint Analysis
2019
29 Oct
CloseoutInProgressLastPtOutActualStart

News

21 December 2018 - Overall closure of recruitment

27 January 2016 -Recruitment to the trial is suspended

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Site Evaluation Visit
Objectives:

Primary objectives:

  • Complete remission rate after 2 phases of induction

Secondary objectives:

  • EFS at 1 year
  • Treatment related mortality
  • C+E62omplete remission rate after 1 phase of induction
  • Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
  • Overall Survival at 1 year
  • Tolerability of treatment as determined by occurrence of key adverse effects
  • Duration of in-patient hospitalisation
  • Relationship between performance status/co-morbidity and treatment option chosen
  • Quality of life aspects assessed at various time points.

Eligibility

Inclusion Criteria:
  • Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
  • Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before study registration)
  • Written informed consent
Exclusion Criteria:
  • Known HIV infection
  • Blast transformation of CML
  • Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24;q32) and variant c-myc translocations e.g. t(2;8)(p12;q24), t(8;22)(q24;q11)
  • Women who are pregnant or lactating

Registration Details

Patient registration will be undertaken centrally at UCL CTC and this must be performed prior to commencement of any study treatment/intervention. Patients may be given a steroid pre-phase of 5-7 days prior to study registration. This should be sufficient time to obtain confirmation of Philadelphia status.
Following pre-treatment evaluations (as detailed in section 5.1), confirmation of eligibility and consent of a patient at a site, the registration form must be fully completed and then faxed to UCL CTC. The faxed registration form will be used to confirm patient eligibility at UCL CTC.
A patient may be entered onto the registration only pathway of the study retrospectively at any point during their first phase of treatment. All efforts should still be made to send diagnostic samples to the MRD laboratory at UCL Cancer Institute for MRD analysis.

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
5 results
Order by
Accrual rate
Activation date
NL-Rotterdam-ERASMUSMC
1
19 Nov 2015
NL-Den Haag-HAGA
NL-Zwolle-ISALA
NL-Maastricht-MUMC
NL-Groningen-UMCG
= Active hospitals
= Inactive hospitals

Participating Parties

Downloads

Up