A study of ofatumumab to treat leukaemia with bulky lymph nodes

Phase 1

• Conditions: Chronic lymphocytic leukaemia; MedDRA version: 18.1Level: LLTClassification code 10068852Term: B-cell chronic lymphocytic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023066-52-SK
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-03
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the study treatment(s) that may impact subject eligibility is provided in the IB and summary of product characteristics (SmPC) for Arzerra, and the prescribing information of marketed products used as physicians’ choice.
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. Have bulky lymphadenopathy, defined as at least 1 lymph node >5cm
3. The subject must be refractory to fludarabine treatment, defined as:
a. No response to at least 2 cycles of a fludarabine-containing regimen, or
b. A partial response or better after at least 2 cycles of a fludarabine-containing regimen for a duration of less than 6 months
4. Active disease requiring CLL therapy
5. Age atleast = 18 years of age
6. Had at least 2 prior therapies for CLL
7. ECOG Performance Status of 0-2
8. Signed written informed consent prior to performing any study-specific procedures

French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 69
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
1. Prior allogeneic stem cell transplantation at any time, or prior autologous stem cell transplantation within 6 months of planned randomization.
2. Treatment with any known unapproved drug substance or experimental therapy within 4 weeks prior to planned dosing, 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.
3. Known transformation of CLL (e.g. Richter’s transformation), prolymphocytic leukaemia (PLL), or CNS involvement of CLL.
4. Active Autoimmune Haemolytic Anaemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment.
5. 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*).
* If HBV DNA is negative, subject may be included but must undergo HBV DNA monitoring(see Section 7.3.3.4 of study protocol). Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.
6. Known HIV positive.
7. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation in this study.
8. 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 or if in the opinion of the investigator it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data.
9. Non-protocol corticosteroid usage except a maintenance dose corresponding to = 10 mg of prednisone at the time of planned dosing.
10. Screening laboratory values:
• Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance) or,
• Total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert’s syndrome) or,
• Alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
11. Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator is a contraindication to their participation in the present study
12. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified