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

NCT02412267 | Completed Phase 2

• 1 other identifier: NCC1001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of ofatumomab in combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following failure to combination rituximab and anthracycline based chemotherapy. Participants with the option of potentially curative stem cell therapy may proceed to high dose chemotherapy and stem cell rescue. Participants with disease not considered curable with stem cell therapy, ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study drugs.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  Response (partial or complete response) status will be evaluated following two cycles of ofatumumab in combination with ICE chemotherapy

  5 years

Secondary Outcomes (2)

• Progression free survival as measured from time of treatment start to time of disease progression

  5 years

• Safety and tolerability of Ofatumomab in combination with ICE chemotherapy as measured by CTCAE

  5 years

Study Arms (1)

O-ICE

EXPERIMENTAL

O-ICE: Ofatumumab 1000mg intravenous (IV) infusion on Day 1 and Day 8 of cycle 1 of the salvage chemotherapy, and thereafter on Day 1 of each cycle; Ifosfamide 1667 mg/m2 IV infusion over 2 hours on days 1,2,3 of each cycle; Carboplatin 5 x ((25 + Creatinine clearance (CrCl)) IV in 250 ml Normal Saline over 1 hour on day 1 of each cycle; Etoposide 100mg/m2/day IV infusion day 1,2,3 over 45 to 60 minutes of each cycle.

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

Interventions

O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide) DRUG

Ofatumab in combination with ICE (Ifosfamide, Carboplatin, Etoposide) are given to subjects according to protocol schedule

Also known as: Arzerra, Mitoxana, Paraplatin, Etopophos

O-ICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refractory or relapsed CD20 positive DLBCL following rituximab combined with chemotherapy.
• Participants must have measurable disease
• ECOG performance status 0-2
• 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
• Fully recovered (≤ Grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Any previous cancer therapy for lymphoma, with the exception of Rituximab in combination with chemotherapy (not more than 1 prior line of chemotherapy)
• Participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
• Participants who have had radiotherapy and/ or major surgery within 3 weeks prior to study entry
• 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
• Concurrent use of any other anti-cancer therapies or study agents.
• Presence of symptomatic or uncontrolled brain or central nervous system lymphomatous lesions
• 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.
• Known or suspected hypersensitivity to study treatments.
• History of HIV or Hepatitis C
• 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.
• Pregnant or lactating women.
• 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.
• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

National Cancer Centre

Singapore, Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ofatumumab; Ifosfamide; Carboplatin; Etoposide; etoposide phosphate

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Soon Thye Lim, Dr

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

SG (1)