Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02412267
• Date of registration: 31/03/2015
• Prospective Registration: No
• Primary sponsor: National Cancer Centre, Singapore
• Public title: Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) DLBL
• Scientific title: An Open-label, Non-randomized Phase 2 Study of Ofatumomab (O) in Combination With ICE (Ifosfamide, Carboplatin, Etoposide)-Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
• Date of first enrolment: April 2011
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02412267
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Singapore

Contacts

• Name: Soon Thye Lim, Dr
• Affiliation: National Cancer Centre, Singapore

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Refractory or relapsed CD20 positive DLBCL following rituximab combined with
chemotherapy.

2. Participants must have measurable disease

3. ECOG performance status 0-2

4. Unless due to lymphomatous involvement, participants must have adequate organ and
marrow function as defined below:

- Hemoglobin = 10g/dL

- Absolute neutrophil count = 1500/mm3

- Platelets = 100 000/mm3

- ALT and AST = 3 x upper limit of normal (ULN),

- Total serum bilirubin = 1.5 x ULN

- Serum creatinine = 1.5 x ULN

5. Fully recovered (= Grade 1 or returned to baseline or deemed irreversible) from the
acute effects of prior cancer therapy before initiation of study drug

6. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Any previous cancer therapy for lymphoma, with the exception of Rituximab in
combination with chemotherapy (not more than 1 prior line of chemotherapy)

2. Participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for
nitrosoureas or mitomycin C) prior to study entry

3. Participants who have had radiotherapy and/ or major surgery within 3 weeks prior to
study entry

4. Participants who have had systemic corticosteroids for the purpose of treating
lymphoma within 2 weeks prior to study entry are ineligible. Patients receiving
stable (not increased within the last month) chronic doses of systemic
corticosteroids with a maximum dose of 20 mg of prednisolone (or equivalent) per day
are eligible if they are being given for disorders other than lymphoma

5. Concurrent use of any other anti-cancer therapies or study agents.

6. Presence of symptomatic or uncontrolled brain or central nervous system lymphomatous
lesions

7. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, clinically significant cardiac disease including a history of cardiac
disease or congestive heart failure > NYHA class 2, unstable angina (anginal symptoms
at rest) or new-onset angina within the last 3 months or myocardial infarction within
the past 6 months, significant cardiac arrhythmias and/ or requiring
anti-arrhythmics; pulmonary disease; liver diseases such as cirrhosis, chronic active
or persistent hepatitis; or acute/ chronic medical/ psychiatric illness/ social
situations or laboratory abnormality that may increase the risk associated with study
participation or study drug administration, or limit compliance with study
requirements, or interfere with the interpretation of study results, and in the
judgment of the investigator would make the patient inappropriate for entry into this
study.

8. Known or suspected hypersensitivity to study treatments.

9. History of HIV or Hepatitis C

10. Individuals with a history of a different malignancy, other than treated cervical
cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible,
except if they have been disease-free for at least 5 years, and are deemed by the
investigator to be at low risk for recurrence of that malignancy OR other primary
malignancy is neither currently clinically significant nor requiring active
intervention.

11. Pregnant or lactating women.

12. Women of childbearing potential, including 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 ofatumumab therapy. Adequate
contraception is defined as hormonal birth control, intrauterine device, double
barrier method or total abstinence. Women of childbearing potential must have a
negative pregnancy test prior at screening.

13. Male subjects unable or unwilling to use adequate contraception methods from the time
of first dose of study medication until one year after the last dose of ofatumumab.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Large B-cell Lymphoma

Intervention(s)

Drug: O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)

Primary Outcome(s)

Response rate as measured by the new international criteria proposed by Cheason for response in non Hodgkin's lymphoma at the end of cycle 2 ofatumomab [Time Frame: 5 years]

Secondary Outcome(s)

Progression free survival as measured from time of treatment start to time of disease progression [Time Frame: 5 years]

Safety and tolerability of Ofatumomab in combination with ICE chemotherapy as measured by CTCAE [Time Frame: 5 years]

Secondary ID(s)

NCC1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline