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Adult T-Cell Leukemia and Lymphoma (ATL)Phase 1NCT00355472

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

A Phase 1 study testing KW-0761 in people with Adult T-Cell Leukemia and Lymphoma (ATL) and Adult Peripheral T-Cell Lymphoma (PTCL), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

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

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL). Read more about this study

Who is it for?
Ages 20 to 69 years
What is being tested?
KW-0761
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteJapan
Study dates
Feb 2007to Oct 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following:
  • ATL (Adult T-Cell Leukemia-Lymphoma)
  • Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody;
  • Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry);
  • PTCL (Peripheral T-Cell Lymphoma)
  • Includes Mycosis Fungoides and Sezary Syndrome;
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  • 2: Relapsed to the latest standard chemotherapy;
  • 3: Received at least one prior chemotherapy;
  • 4: After 4 weeks from a prior therapy;
  • 5: Have measurable disease;
  • 6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
  • 7: Male or female, at least 20 years and not older than 70 years of age;
  • 8: Signed written informed consent;
  • 9: Stay in hospital for 4 weeks;
  • 10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry);
  • 11: Adequate bone marrow, hepatic and cardiac function including the followings:
  • Neutrophil count ≥ 1,500 /mm3,
  • Platelets ≥ 75,000 /mm3,
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN;
  • Serum SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5.0 x ULN if considered due to disease involvement in liver);
  • Serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if considered due to disease involvement in liver)
  • Serum calcium ≤ 11.0 mg/dL
  • PaO2 ≥ 65 mmHg or SaO2 ≥ 90%
  • No clinically significant Electrocardiogram abnormality
  • Left Ventricular Ejection Fraction ≥ 50% [by ECHO or MUGA]

Who cannot join

  • Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results;
  • Active tuberculosis;
  • Prior stem cell transplantation;
  • Myocardial infarction (within 12 months prior to the study entry);
  • Concurrent acute or chronic hepatitis, or cirrhosis;
  • Anti-HCV: positive, Anti-HIV: positive
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  • Concurrent active malignant disease;
  • Known allergic reaction to antibody therapy;
  • Concomitant treatment with systemic steroids;
  • Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases;
  • Evidence of CNS metastasis at baseline;
  • Prior and Concurrent spinal cord disease;
  • Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study;
  • Female patients who are pregnant or breast feeding;
  • Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;
  • Treatment with any other investigational agent within the 4 months prior to study entry;
  • For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Tokyo

Other trials in Japan

About this study

Official title: Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Read the detailed description

This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

Being tested
KW-0761
Keywords
Adult T-Cell Leukemia, ATL, Adult Peripheral T-Cell Lymphoma, PTCL
Medical subject headings
Leukemia-Lymphoma, Adult T-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

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

  • KW-0761Drug

    IV administration at 4 escalating dose levels.

Study groups in NCT00355472
Study groupRoleWhat they receive
1ExperimentalKW-0761
Receives: Drug: KW-0761

What is being measured

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

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.

    Measured: 28 days

  2. Maximum Tolerated Dose (MTD)

    The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.

    Measured: 28 days

  3. Pharmacokinetics-Plasma KW-0761 Concentrations

    Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.

    Measured: 0-7 days post final dose

  4. Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)

    The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.

    Measured: 0-7 days post final dose

  5. Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)

    The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.

    Measured: 0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).

Secondary outcomes (2)

  1. Antitumor Effect

    The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).

    Measured: 50 days

  2. Time to Progression (TTP)

    TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.

    Measured: Baseline to response

Timeline

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

  1. First posted24 Jul 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355472
Sponsor's protocol ID
0761-0501
Status last verified
Oct 2012
First submitted
20 Jul 2006
Last updated
18 Oct 2012
Data monitoring committee
No

Publications

  • Ishida T, Ueda R. CCR4 as a novel molecular target for immunotherapy of cancer. Cancer Sci. 2006 Nov;97(11):1139-46. doi: 10.1111/j.1349-7006.2006.00307.x. Epub 2006 Sep 5.

    PubMed 16952304

  • Yano H, Ishida T, Inagaki A, Ishii T, Ding J, Kusumoto S, Komatsu H, Iida S, Inagaki H, Ueda R. Defucosylated anti CC chemokine receptor 4 monoclonal antibody combined with immunomodulatory cytokines: a novel immunotherapy for aggressive/refractory Mycosis fungoides and Sezary syndrome. Clin Cancer Res. 2007 Nov 1;13(21):6494-500. doi: 10.1158/1078-0432.CCR-07-1324.

    PubMed 17975162

  • Yano H, Ishida T, Inagaki A, Ishii T, Kusumoto S, Komatsu H, Iida S, Utsunomiya A, Ueda R. Regulatory T-cell function of adult T-cell leukemia/lymphoma cells. Int J Cancer. 2007 May 1;120(9):2052-7. doi: 10.1002/ijc.22536.

    PubMed 17278106

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KW-0761 in people with Adult T-Cell Leukemia and Lymphoma (ATL) and Adult Peripheral T-Cell Lymphoma (PTCL), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

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 26 inclusion and 17 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 18 Oct 2012. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: 28 days). The study lists 5 primary outcomes in all. 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 NCT00355472, which also lists 3 linked publications.

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 18 Oct 2012.

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