Phase II trial of single agent ofatumumab in relapsed/refractory mantle cell lymphoma

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's); Cancer; Mantle cell lymphoma

• Registration Number: ISRCTN32524443
• Lead Sponsor: Plymouth Hospitals NHS Trust (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24666179 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-17
• Study Completion: 2013-01-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Male or female patients over the age of 18 years
2. A confirmed diagnosis of MCL including expression of cyclin D1 or evidence of t(11;14), by cytogenetics, fluorescent in situ hybridisation (FISH) or polymerase chain reaction (PCR)
3. Relapse/refractory MCL following the completion of a minimum of one previous course of cytotoxic chemotherapy treatment
4. All previous chemotherapy regimens are permissible (including those containing Rituximab)
5. Measurable disease
6. World Health Organization (WHO) score of 0 - 2
7. Absolute neutrophil count greater than or equal to 500 cells/µL not related to lymphoma
8. Platelets greater than or equal to 30,000 cells/µL not related to lymphoma
9. Toxic effects of previous therapy or surgery resolved to Grade 2 or better (with the exception of the haematological parameters discussed above)
10. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Exclusion Criteria

1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
2. Anti-neoplastic therapy within 3 weeks before Day 1
3. Nitrosoureas within 6 weeks before Day 1
4. Radiation therapy within 3 weeks before Day 1
5. Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within three months before Day 1
6. Major surgery within 2 weeks before Day 1
7. Active systemic infection requiring treatment
8. Previous treatment or suspected hypersensitivity to Ofatumumab
9. Any concurrent active malignancy within the last 5 years ? patients who have a history of completely resected Non-melanoma skin cancer or in-situ carcinoma are eligible
10. Aspartate transaminase greater than 2.5 x upper limit of normal (ULN), or alanine transaminase greater than 2.5 x ULN, alkaline phosphatase greater than 2.5 x ULN unless due to disease involvement of the liver or bone
11. Total bilirubin greater than 1.5 x ULN unless due to liver involvement with MCL or known history of Gilbert's disease
12. Serum creatinine greater than 2.0 x ULN (unless normal creatinine clearance)
13. Female subject is pregnant or breast-feeding; confirmation of this will be required for female patients of child-bearing potential. For the purpose of this study, female of child-bearing potential is defined as women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
14. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
15. Moderate or severe Chronic Obstructive Pulmonary Disease
16. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
17. Treatment with another investigational agent for at least four weeks prior to enrolment into this study. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study.
18. Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease. Patients with these conditions may be included subject to PI assessment).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To evaluate the rates of overall response to ofatumumab in terms of complete response (CR).<br><br> When 9 evaluable patients have received Ofatumumab an interim analysis will be performed. If two or more patients respond the trial will continue until a further 25 evaluable patients have received the research treatment.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease progression<br> 2. Liver toxicity<br> 3. Other unacceptable toxicity<br> 4. Withdrawal of patient consent<br><br> When 9 evaluable patients have received Ofatumumab an interim analysis will be performed. If two or more patients respond the trial will continue until a further 25 evaluable patients have received the research treatment.<br>