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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON 101 CLL/OMB112517


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


HO101 news

  • The HOVON 101 CLL (PROLONG)/OMB112517 study has been closed for the inclusion of new patients.
  • Please note that this study applies to both 2nd and 3rd line treatment.
  • On the second item of the inclusion criteria, the confirmation by CT scan of the response is not necessary.

1. Overview



Summary

A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy


Status

closed


Members

Participating groups: HOVON and Nordic Group



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Study specific


Target number of patients

532


Current number of patients

0


Date of activation

09-Apr-2010


Approved by

CCMO: NL30218.018.10 (February 12, 2010)
MEC: AMC 2010-017 (April 9, 2010)


Study objectives

Primary objective:
To evaluate PFS of subjects treated with ofatumumab maintenance treatment compared to no further treatment after remission induction in subjects with relapsed chronic CLL

Secondary objectives:
To evaluate the improvement in response, improvement in response time to next CLL treatment and overall survival in subjects receiving ofatumumab maintenance compared to no further treatment
To evaluate the PFS after next-line therapy and the time to progression after nextline therapy
To evaluate the safety and tolerability in subjects with CLL receiving ofatumumab maintenance compared to no further treatment
To evaluate the health-related quality of life in subjects with CLL receiving ofatumumab maintenance compared to no further treatment as assessed by changes in patient reported outcome (PRO) measures relative to baseline
To evaluate prognostic marker correlation with clinical response in subjects with CLL receiving ofatumumab maintenance compared to no further treatment
To evaluate ofatumumab pharmacokinetic parameters in subjects with CLL receiving maintenance ofatumumab every 2 months


2. Patient eligibility criteria



Inclusion criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:
1. Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines
2. At least PR according to the revised 2008 NCI-WG CLL criteria within 3 months of the response assessment after the last dose of 2nd/3rd line treatment
3. The anti-leukemic treatment before study entry should have been for at least 3 months or 3 cycles
4. ECOG Performance Status of 0-2
5. Signed written informed consent prior to performing any study-specific procedures


Exclusion criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last antileukemic therapy NOTE: Subjects refractory to rituximab therapy as
last therapy are permitted
2. Prior maintenance therapy
3. Known transformation of CLL (e.g. Richter’s transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL
4. Active Autoimmune Hemolytic Anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
5. Previous autologous or allogeneic stem cell transplantation
6. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C (Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded*.)
7. Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
8. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
9. History of significant cerebrovascular disease or event with symptoms or sequelae
10. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study
11. Glucocorticoid unless given in doses ≤ 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoid) if for exacerbations other than CLL (e.g. asthma)
12. Known HIV positive
13. Screening laboratory values:
• Platelets<50 x 109/L
• Neutrophils<1.0 x 109/L
• Creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
• Total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of CLL)
• Alanine Aminotransferase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
• Alkaline phosphatase > 2.5 times upper normal limit
14. Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation
15. Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other
interventional clinical study
16. Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence,
oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive
cap plus spermicidal agent).


3. Registration (& randomization) of patients



4. Participating parties



Principal Investigator(s)

Dr. C.H. Geisler (Rigshospitalet Copenhagen)
Prof. Dr. M.H.J. van Oers (AMC)
Mw.Dr. S. Wittebol (Meander MC)


Principal investigator

Marinus HJ van Oers, MD, The Netherlands (m.h.vanoers@amc.uva.nl)
Shulamiet Wittebol, MD, The Netherlands (s.wittebol@meandermc.nl)
Christian Geisler, MD, Denmark (geisler@regionh.dk)


Trial manager

R. Hollestein (r.hollestein@erasmusmc.nl)


Central data management

GSK


5. Participating sites



Site
Included patients *
NL-Amersfoort-Meander MC
0
NL-Amsterdam-AMC
0
NL-Amsterdam-Antoni van Leeuwenhoek ZH
0
NL-Amsterdam-OLVG
0
NL-Breda-Amphia ziekenhuis, locatie Langendijk
0
NL-Den Bosch-Jeroen Bosch ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Deventer-Deventer ziekenhuizen
0
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
0
NL-Enschede-Medisch Spectrum Twente
0
Show 9 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




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