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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


Phase 3
N/A
N/A
Open (Enrolling)
Both
Leukaemia, Lymphocytic, Chronic

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Trial Information

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


Inclusion Criteria:



- Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG
guidelines (Hallek, 2008)

- 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

- The anti-leukemic treatment before study entry should have been at least 3 months or
3 cycles

- ECOG Performance Status of 0-2

- Signed written informed consent prior to performing any study-specific procedures

Exclusion Criteria:

- Known primary or secondary fludarabine-refractory subjects, defined as treatment
failure (failure to achieve a CR or PR) or disease progression within 6 months

- Prior maintenance therapy

- Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia
(PLL), or CNS involvement of CLL

- 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

- Previous autologous or allogeneic stem cell transplantation

- 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

- Other past or current malignancy (with the exception of basal cell carcinoma or the
skin or in situ carcinoma of the cervix or breasts) 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

- 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 exta 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

- History of significant cerebrovascular disease or event with symptoms or sequelae

- Significant concurrent, uncontrolled medical condition that in the opinion of the
investigator or GSK medical monitor contraindicates participation in this study

- Other anti-leukemic use of medications including glucocorticoids

- Known HIV positive

- Screening laboratory values: platelets <50 x 109/L, neutrophils<1.0 x 109/L,
Creatinine > 1.5 X upper normal limit (unless normal creatinine clearance), total
bilirubin >1.5 X upper normal limit, ALT >2.5 X upper normal limit (unless due to
liver involvement of CLL), alkaline phosphase > 2.5 X upper normal limit

- Known or suspected hypersensitivity to ofatumumab that in the opinion of the
investigator or medical monitor contraindicates study participation

- 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 Note: Participation in any other interventional
clinical study after disease progression during post PD follow-up is permitted

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

280 events, ~72 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Institutional Review Board

Study ID:

112517

NCT ID:

NCT01039376

Start Date:

May 2010

Completion Date:

May 2017

Related Keywords:

  • Leukaemia, Lymphocytic, Chronic
  • maintenance therapy
  • anti-CD20 monoclonal antibody
  • ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteHartford, Connecticut  06106
GSK Investigational SiteCoeur d'Alene, Idaho  83814
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteSalt Lake City, Utah  84107