AzTrials
AzTrials

Diffuse Large B-cell LymphomaPhase 3NKCellNCT00846157

Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients

A Phase 3 study testing NKM injection in people with Diffuse Large B-cell Lymphoma, run by NKBio Co.Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Primary objective: To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
NKM injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteSouth Korea
Study dates
Sep 2007to Sep 2014
Phase
Phase 3
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women of the age between 20 and 70
  • The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL.
  • The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ
  • The patients who have not received NK / T-Cell lymphocyte therapy.
  • The patients who are expected to survive for at least 3 months.
  • The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure.
Show all 21Show fewer
  • Women of child bearing potential must have a negative pregnancy test within 7 days prior to study registration and agree to use adequate birth control during study treatment.
  • The patients with ADL classification (ECOG) scale 0, 1, 2
  • Patients who satisfy following hematologic criteria
  • WBC ≥ 3,000 / ㎕
  • platelet count ≥ 75,000 / ㎕
  • serum total bilirubin ≤ two times of upper limit of normal values of each laboratory
  • serum creatinine ≤ two times of upper limit of normal values of each laboratory
  • lymphoma patients who satisfy the following criteria
  • good renal function (GFR> 50)
  • good hepatic function (total bilirubin level ≤ three times of upper limit of normal values of each test laboratory transaminases ≤ 5 times of the upper limit of normal value of each testing laboratory)
  • The patients with negative HIV surface antigen
  • The patients with negative HBV
  • The patients with negative HCV
  • The patients who have not received immunotherapy.
  • The patients who have not experienced tuberculosis infection within recent 6 months.

Who cannot join

  • The minors under 20 years of age (In accordance with Civil Code)
  • The patients diagnosed with other types of lymphoma
  • The patients who have central nervous system or meningeal involvement by lymphoma.
  • The patients who have contraindication of chemotherapy regimen
  • The patients with another active severe disease.
  • The patients who have history of cancer within 5 years
Show all 20Show fewer
  • Uncontrolled hypertension patients
  • The patients who have hypersensitivity to Erythropoietin.
  • The patients who have the following diseases or the experience to have following disease within 3 months.
  • Myocardial infarction
  • Unstable coronary disease
  • Uncontrolled cardiac insufficiency.
  • Venous thrombosis
  • Pulmonary embolism
  • The patients who have experience to be treated with the pharmaceutical for clinical trials.
  • Pregnant and lactating women or women of childbearing age not using adequate contraceptive method.
  • The patients with clinically serious bacterial, viral or fungal infection
  • The patients of the test group who have the problem in NK cell cultures (Investigator will decide on this criteria with basis generated during NK cell culture)
  • Patients with autoimmune diseases
  • The patients who underwent visceral resection related with Lymphoma.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of korea

    Banpo-dong, Seoul, 137-701

Other trials in South Korea

About this study

Official title: R-CHOP Therapy Compared With R-CHOP Plus Biocell Natural Killer Mixture in Patients With DLBCL (Diffuse Large B Cell Lymphoma);A Randomized, Open-label,Multi-center Trail

Primary objective:

  • To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.
Being tested
NKM injection
Keywords
natural killer cell, DLBCL (Diffuse Large B Cell Lymphoma)
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Dendritic Cell Sarcoma, Interdigitating

What participants receive

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

  • NKM injectionBiological

    Also called NKCell

    NKCell about 100mg IV for 6times in each chemotherapy period.

Study groups in NCT00846157
Study groupRoleWhat they receive
controlNo interventionRituximab 375mg/m2 IV administered on day 1. Cyclophosphamide 750mg/m2 IV for 2hours,Adriamycin 50mg/m2 ,Vincristine 1.4mg/m2 IV respectively. Prednisone 60mg P.O. per day for 5 days.
ActiveActive comparatorR-CHOP plus Natural Killer Cell therapy
Receives: Biological: NKM injection

What is being measured

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

  1. Event Free survival

    Measured: 3 years

Secondary outcomes (1)

  1. Progression free survival

    Measured: 3 years

Timeline

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

  1. First posted18 Feb 2009 (estimated)
  2. Study startSep 2007
  3. Primary completionSep 2011 (estimated)
  4. Study completionSep 2014 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00846157
Sponsor's protocol ID
NKMGI 4-06
Acronym
NKCell
Status last verified
Feb 2009
First submitted
15 Feb 2009
Last updated
28 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NKM injection in people with Diffuse Large B-cell Lymphoma, run by NKBio Co.Ltd. at 1 site in South Korea.

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 21 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Event Free survival (time frame: 3 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 NCT00846157.

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 28 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in