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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON 88 CLL


News
1. Overview
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


Ho88 news

21 DEC 2012

The study is closed for entry of new patients, because it has reached its target of 50 patients.

04 DEC 2012

Within a few months we expect to include the last patient in the HOVON88. With the current inclusion rate we expect that the study will be closed for entry of new patients in February 2013. In order to prevent the situation where a patient has been informed and invited to participate but cannot be registered anymore because of closure of the study in the time needed for the informed consent, please inform HOVON Data Center (HDC) if you have a patient that will be informed about the HOVON 88 CLL study. These patients will be put on a list. When, after screening, the patient is eligible, HOVON Data Center is to be called to see whether it is still possible to register the patient in study.

 

You will be informed when the target of 50 patients has been reached and the study will be closed for inclusion of new patients. Until then please inform us if you intend to inform a new patient about the study.

 

09-08-11: Implementation of protocol amendment (protocol version 28MAY2011) in The Netherlands, Belgium followed at 23-08-11.

 

10-12-10: Please give antibiotics prophylaxis according to local procedures during R-DHAP therapy. Protocol amendment will follow.

 

05-06-09: SOP MRD measurement and analysis, LDM + LI meeting presentations added to Other documents.

 

For the Ho88 CLL study there is no central laboratory involved.

MRD by flowcytometry has to be performed by your own laboratory (or collaboration with other hospital)

PB or BM samples for future molecular studies have to be preserved in liquid nitrogen at your own laboratory.

 

 


1. Overview



Summary

Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High-risk Relapsed or Refractory CLL


Status

closed



Type of study

Prospective Phase II study


Type of monitoring for this study

Site evaluation visits


Target number of patients

50


Current number of patients

46


Date of activation

18-Nov-2008


Date closed

21-Dec-2012


Approved by

EudraCTnr.: 2007-005487-28
CKTO: 29-05-2008
MEC: 17-09-2008


Study objectives

Primary objective:
To assess, on an intention-to-treat basis, the efficacy and safety of a treatment protocol including salvage chemoimmunotherapy (R-DHAP) followed, in the absence of progression, by RIC alloSCT from sibling or unrelated donors, in high-risk CLL patients as defined in chapter 8.1.1, as measured by the progression free survival as defined in chapter 14.

Secondary objectives:
To assess the safety and toxicity of three courses of R-DHAP
To assess the response to three courses of R-DHAP.
To assess PFS and OS after alloSCT.
To asses PFS and OS after maximally 6 R-DHAP in case no alloSCT was performed
To assess disease status at two years after SCT.
To assess the incidence and course of MRD in patients with CR
To assess overall survival from registration.
To assess the incidence of complete, partial and no engraftment.
To evaluate the incidence and severity of acute and chronic GVHD, and of other treatment related toxicity;
To evaluate the response of progressive disease or increasing MRD to lowering of immunosuppression or DLI.
To assess the time to next treatment excluding MRD triggered lowering of immunosuppression or DLI.
To assess the prognostic value of risk factors at entry including IgH mutation status and karyotypic abnormalities with respect to PFS.
To assess the functionality of mutated p53 at entry and at relapse.


2. Patient eligibility criteria



Inclusion criteria

Inclusion criteria:
B-CLL confirmed according to WHO Classification;
Fludarabine refractory, defined as no response or relapse within 12 months after the last administration of fludarabine monotherapy or fludarabine containing regimen, and needing treatment, or
Refractory or relapsed and needing treatment and having deletion of 17p13 or
Refractory or relapsed within 24 months after the last administration of fludarabine combined with a monoclonal antibody and needing treatment;
Age 18-70 years inclusive;
WHO performance status <= 2 (see appendix E);
HCT-CI <= 2 (see appendix F);
Written informed consent.


Exclusion criteria

Exclusion criteria:
Intolerance to exogenous protein administration
Previously treated with DHAP
Richter’s transformation;
Suspected or documented CNS involvement by CLL;
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
Severe neurological or psychiatric disease;
Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times upper limit of normal) except when caused by leukemic infiltration;
Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
Active, uncontrolled infections;
Patient known to be HIV-positive;
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential
Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women).


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number (optional)
Date of birth
Sex
Date of written informed consent
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Dhr. Dr. M. van Gelder (AZ Maastricht)


Statistician(s)

Dr. W. Ghidey Alemayehu (Erasmus MC - Daniel)
Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Trial Manager(s)

Mw. I. Meulendijks (Erasmus MC - Daniel)


Central Data Manager(s)

Mw. M.C.J. Abrahamse - Testroote (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. S. Jägers (Erasmus MC - Daniel)
Mw. W.M Keller (Erasmus MC - Daniel)
Mw. L. Sitniakowsky (Erasmus MC - Daniel)
Dhr. T. Volker (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Mw. M. Spiering (AMC)


Coordinating investigator(s)

D. Dierickx (daan.dierickx@uz.kuleuven.ac.be)


Trial manager

I. Meulendijks (L.meulendijks@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
4
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Leuven-UZ Gasthuisberg
0
NL-Alkmaar-MC Alkmaar
1
NL-Amstelveen-Ziekenhuis Amstelland
1
NL-Amsterdam-AMC
7
NL-Amsterdam-VUMC
5
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Groningen-UMCG
2
NL-Hoofddorp-Spaarne ziekenhuis
1
Show 8 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


 Protocol



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