HOVON HO96 SCT

Closed

Main info

Identifier:
HO96 GVHD SCT
Sponsor:
HOVON
Working group party:
SCT & Supportive care
Age:
18-70
Stage:
1st Line
Included patients:
494
(of 500)
Active sites:
11
(of 9)
Title:

Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial.

Timeline

Scheduled
Actual
2009
30 Sep
FPI
2010
24 Feb
Opportunity
2010
24 Feb
EC Approval
2010
14 Apr
Activated
2010
14 Apr
First Site
2010
29 Apr
FPI
2018
12 Jun
ClosedForInclusionActualStart
2019
15 May
Endpoint Analysis
2023
08 Jun
CloseoutInProgressLastPtOutScheduledStart

News

Inclusion of new patients closed per July 3th, 2018.

Per 30 April 2018 patients for the HOVON 96 GVHD study will be entered via the HOVON Data Center instead of directly via TOP. Please inform HOVON Data Center (HDC) if you have a patient that will be informed about the HOVON 96 GVHD study. These patients will be put on a list.

Per 1 October 2013 protocol amendment of 17 july2013 is active. Introduced is a short-course GVHD prophylaxis consisting of post-transplant cyclophosphamide. The inclusion in the Quality of Life investigation of the HOVON 96 GVHD study has been closed for entry of new patients. It is closed, because it has reached its target of 200 patients. The patients already participating in Quality of life will continue in filling in Quality of Life Questionaires according to protocol.

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Not any more
Objectives:

Objectives:

  • to reduce the proportion of patients without GVHD within 180 days post-allo-SCT,
  • to reduce the progression rate and
  • to improve the progression free survival using a time restricted immunosuppressive regimen as compared to a prolonged, standard immunosuppressive regimen, or using a post-transplant regimen with high-dose cyclophosphamide.
  • to asses the impact of allogeneic SCT on the quality of life in a prospectively treated cohortmof patients

Additional objective:

  • to develop a predictive score, by means of clinical and laboratory parameters (using genomic and proteomic approaches) that allows for accurate identification of patients at high risk of severe GVHD as well as for identification of patients, who will not develop GVHD

Eligibility

Inclusion Criteria:
  • Age 18-70 inclusive
  • AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
  • Planned allogeneic stem cell transplantation
  • Related or unrelated donor with a 8/8 HLA match (HLA A, B, C, DRB1)
  • WHO performance status 0-2
  • Written Informed Consent
  • Negative pregnancy test (if applicable)
  • Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women)
Exclusion Criteria:
  • Renal dysfunction (serum creatinine > 150 µmol/L or clearance < 50 ml/min)
  • Patients with active, uncontrolled infection
  • Cord Blood transplantation
  • Patients receiving ATG pre-transplantation as part of the conditioning regimen
  • Patients with progressive disease in case of MM, CLL, NHL, HL
  • Patients with > 5% marrow blasts in case of AML, ALL, CML
  • Patients with EMD in case of AML, ALL, CML

Registration Details

Eligible patients should be registered and randomized before start of treatment. Patients need to be registered at the HOVON Data Center of the Erasmus MC Rotterdam – Clinical Trial Center via the Internet or by phone call: +31.10.7041560 or fax +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET. A logon to TOP can be requested at the HOVON Data Center for participants.
The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Local patient code (optional)
  • Sex
  • Date of birth
  • Date written informed consent
  • Will the patient particpate in the QoL part of the trial (no longer applicable)
  • Eligibility criteria (see 8.1)

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
11 results
Order by
Accrual rate
Activation date
NL-Rotterdam-EMCDANIEL
277
12 Apr 2010
NL-Amsterdam-VUMC
78
30 Sep 2010
NL-Amsterdam-AMC
58
26 Apr 2010
NL-Zwolle-ISALA
40
10 Nov 2010
NL-Groningen-UMCG
31
21 Jan 2011
NL-Maastricht-MUMC
6
11 Jan 2017
BE-Leuven-UZLEUVEN
2
08 Oct 2010
NL-Utrecht-UMCUTRECHT
1
24 Dec 2013
BE-Roeselare-AZDELTA
1
05 Aug 2011
BE-Antwerpen-ZNASTUIVENBERG
20 Sep 2011
BE-Liege-CHULIEGE
30 Jun 2011
= Active hospitals
= Inactive hospitals

Participating Parties

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