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An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukaemia, Lymphocytic, Chronic

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Trial Information

An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL


Inclusion Criteria:



1. Patients with active B-CLL and with an indication for treatment

2. Age ≥ 18 years

3. Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out

Exclusion Criteria:

1. Any previous treatment for B-CLL or any other treatments that can be considered
active against B-CLL

2. Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL
(e.g. asthma)

3. Known transformation of B-CLL

4. Known CNS involvement of B-CLL

5. Past or current malignancy, except for:

1. Cervical carcinoma Stage 1B or less

2. Non-invasive basal cell and squamous cell skin carcinoma

3. Malignant melanoma with a complete response of a duration of > 10 years

4. Other cancer diagnoses with a complete response of a duration of > 5 years

6. Chronic or current infectious disease requiring systemic treatment

7. Clinically significant cardiac disease

8. Significant concurrent, uncontrolled medical condition

9. History of significant cerebrovascular disease

10. Known HIV positive

11. Positive serology for hepatitis B, unless due to vaccination

12. Leukapheresis, except as a safety measure before chemotherapy

13. ECOG Performance Status of 3 or 4

14. Patients who at the time of inclusion are not expected to be able to complete the
ofatumumab-FC regimen

15. Patients who have received treatment with any non-marketed drug substance or
experimental therapy within 4 weeks prior to Visit 1

16. Current participation in any other interventional clinical study

17. Patients known or suspected of not being able to comply with a study protocol (e.g.
due to alcoholism, drug dependency or psychological disorder)

18. Breast feeding women or women with a positive pregnancy test at Visit 1

19. Women of childbearing potential not willing to use adequate contraception for up to
one year after last dose of ofatumumab. Adequate contraception is defined as hormonal
birth control or intrauterine device. For patients in the USA the use of a double
barrier method is also considered adequate.

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:

Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion

Outcome Description:

Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as "complete responders". As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter.

Outcome Time Frame:

Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

111774

NCT ID:

NCT00410163

Start Date:

January 2007

Completion Date:

June 2013

Related Keywords:

  • Leukaemia, Lymphocytic, Chronic
  • B-cell
  • cyclophosphamide
  • fludarabine
  • Chronic Lymphocytic Leukemia
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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