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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON 139 CLL (GIVE)


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO139 News

19JUN2017 AM01 has been approved by EC & CA!

All sites have been informed by e-mail and local documentation is currently being gathered

 

28OCT2016 Study has been approved by EC & CA!

All sites have been informed by e-mail and local documentation is currently being gathered

 

 


 

link to eCRF:

 

                                           

 

 

 


Updated documents

Update of 19JUN2017:

- HO139_CCMO_approval_AM01_24APR2017

- HO139_EC approval_AM01_06JUN2017

- HO139_ICF_23JAN2017_AM01

- HO139_Intrekkingsformulier_01JUN2017

- HO139_Lab manual_31MAY2017

- HO139_PIF biobank_01JUN2017_

- HO139_Protocol_23JAN2017_AM01

- HO139_Shipment form_skin biopsy_31MAY2017

- HO139_Signature_Page_Protocol_23JAN2017

 

Update of 19DEC2016:

- Labmanual and shipment forms (LN biopsy instructions changed - no longer FNA allowed)

- IB Venetoclax version 7 addendum 3

- IB Venetoclax + Obinutuzumab version 5, addendum 3

- IB Obinutuzumab version 11

- Insurance update (WMO)

- Instructions for eCRF completion

- Study procedures (an overview of the extra procedures that are not part of the standard care).


1. Overview



Summary

A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of obinutuzumab (Gazyvaro) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens
Acronym: GIVE trial (Gazyvaro In combination with VEnetoclax in CLL)


Status

open


Members

HOVON


Study details



Type of study

Prospective randomized Phase II study


Echelon level

Level D


Echelon level specification

A-D


Type of monitoring for this study

Site evaluation visits


Target number of patients

70


Study objectives

To separately study the efficacy of the two arms of the study of either venetoclax maintenance or MRD-guided venetoclax maintenance after sequential regimens of obinutuzumab (pre-induction) followed by 6 cycles obinutuzumab with venetoclax and 6 cycles of venetoclax (induction) in first-line patients with CLL and unfit for FCR-like regimens.


2. Patient eligibility criteria



Inclusion criteria

♦ Diagnosis of symptomatic CLL (according to IWCLL guidelines, including minimal required markers (CD5/CD19/CD23 triple positive with light chain restriction))
♦ Patients without prior treatment for CLL (Corticoid treatment administered due to necessary immediate intervention is allowed; within the last 10 days before start of study treatment only dose equivalents of maximum 20 mg prednisolone are permitted);
♦ Patients aged ≥ 18 years, not fit for FCR-like regimens, according to the treating physician;
♦ Able to adhere to the study visit schedule and other protocol requirements;
♦ WHO performance status of ≤ 2 (see appendix C);
♦ Laboratory test results within these ranges: - absolute neutrophil count ≥ 1.0 x 109/l and platelet count ≥ 50 x 109/l, unless due to bone marrow infiltration, - creatinine clearance ≥ 45 ml/min .(using 24-hour creatinine clearance or modified Cockcroft−Gault equation (see appendix E) - total bilirubin ≤ 1,5 x ULN unless considered due to Gilbert’s syndrome, - transaminases ≤ 3 x ULN;
♦ Negative serum or urine pregnancy test within 28 days prior to registration (all females of childbearing potential);
♦ Written informed consent
♦ Patient is capable of giving informed consent


Exclusion criteria

♦ Current inclusion in other clinical trials
♦ Intolerance of exogenous protein administration;
♦ History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies. Known sensitivity or allergy to murine products.
♦ Positive hepatitis serology (serology testing required at screening), as follows:
Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity
for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc).
Hepatitis C virus (HCV): Patients with positive hepatitis C serology unless HCV- (RNA) is
confirmed negative.
♦ HIV positive patients;
♦ Active fungal, bacterial, and/or viral infection that requires systemic therapy; Note:
active controlled as well as chronic/recurrent infections are at risk of
reactivation/infection during teatment with obinutuzumab and/or venetoclax);
♦ Vaccination with a live vaccine a minimum of 28 days prior to registration.
♦ Use of any other experimental drug or therapy within 28 days of baseline;
Concurrent use of other anti-cancer agents or treatments;
♦ History of prior malignancy, except for conditions as listed below if patients have
recovered from the acute side effects incurred as a result of previous therapy:
Malignancies surgically treated with curative intent and with no known active disease
present for ≥ 3 years before randomization
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
disease
Adequately treated cervical carcinoma in situ without evidence of disease
♦ Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
heart failure or symptomatic ischemic heart disease) (CTCAE grade III-IV, see
appendix D);
♦ Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
♦ Severe neurological or psychiatric disease (CTCAE grade III-IV, see appendix D);
♦ Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes,
hypertension, hyperthyroidism or hypothyroidism etc.)
♦ Women who are pregnant or lactating;
♦ Fertile men or women of childbearing potential unless: (1). surgically sterile or ≥ 2
years after the onset of menopause (2). willing to use a highly effective contraceptive
method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual
abstinence or barrier method of contraception in conjunction with spermicidal jelly
during study treatment and in female patients for 18 months after end of antibody
treatment and male patients for 6 months after end of treatment.
♦ Any psychological, familial, sociological and geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



Site
Included patients *
NL-Alkmaar-MC Alkmaar
2
NL-Amsterdam-AMC
6
NL-Amsterdam-OLVG
0
NL-Arnhem-Ziekenhuis Rijnstate
2
NL-Breda-Amphia ziekenhuis, locatie Langendijk
1
NL-Delft-Reinier de Graaf Gasthuis
1
NL-Den Bosch-Jeroen Bosch ziekenhuis
1
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
3
NL-Ede-Gelderse Vallei
2
Show 15 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Patient Information & IC form (NL)



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