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Diffuse Large B-cell LymphomaPhase 2DLBLNCT02412267

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

A Phase 2 study testing O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide) in people with Diffuse Large B-cell Lymphoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSingapore
Study dates
Apr 2011to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

Official 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)

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.

Read the detailed description

This is a Phase II, single-arm, non randomized, safety and efficacy study of ofatumumab in combination with salvage ICE chemotherapy (O-ICE) in 61 subjects with relapsed or refractory aggressive B cell lymphoma.

O-ICE would be administered as an inpatient. The cycles are administered at 3 weeks intervals for ICE.

Study subjects who are candidates for high dose chemotherapy (HDC) and autologous stem cell rescue (ASCR) would receive one or two more cycle of ICE salvage chemotherapy with ofatumumab before stem cell mobilization. G-CSF at 10 ug/kg per day after the third or forth cycle of treatment (at the discretion of the treating physician) would be administered until the end of leukapheresis for stem cell mobilization. After the third or forth cycle of salvage chemotherapy, leukapheresis was initiated until a collection of more than 5 x 106 CD34 cells/kg white blood or 5 procedures were performed, whichever occurred first. Collection of <2x106 CD34+ cells/kg from peripheral blood will be considered mobilization failure for the purposes of the study. Leukapheresis and cryopreservation will be performed according to hospital practice. High dose chemotherapy will be administered as per our institution's protocol.

Study subjects who are not candidates for HDC and ASCR would receive at most 6 cycles of salvage chemotherapy with ofatumumab.

Subjects who progressed on treatment would be taken off study protocol.

Being tested
O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Arzerra, Mitoxana, Paraplatin, Etopophos

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

Study groups in NCT02412267
Study groupRoleWhat they receive
O-ICEExperimentalO-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.
Receives: Drug: O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years

Secondary outcomes (2)

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

    Progression evaluation will follow the new international criteria proposed by Cheason for response in non Hodgkin's lymphoma

    Measured: 5 years

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

    Adverse events will be graded following CTCAE (Common Terminology Criteria for Adverse Events) V4.03, and the relationship to the study treatment will be assessed by investigators.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2015 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412267
Sponsor's protocol ID
NCC1001
Acronym
DLBL
Status last verified
Mar 2016
First submitted
31 Mar 2015
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide) in people with Diffuse Large B-cell Lymphoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02412267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.

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