A Phase I, Multicenter, Open-label, Dose-escalation Study to Assess the Safety of Lenalidomide in Patients With Advanced Adult T-cell Leukemia-lymphoma and Peripheral T-cell Lymphomaperipheral T-cell Lymphoma

NCT01169298 | Completed Phase 1 DMC

• 1 other identifier: CC-5013-ATLL-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 6

Brief Summary

To determine the maximum tolerated dose of lenalidomide in patients with adult T-cell leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) who have previously received therapy for ATL and PTCL

Conditions

Adult T-cell Leukemia-Lymphoma; Peripheral T-cell Lymphoma

Keywords

Adult T-cell Leukemia-Lymphoma; Peripheral T-cell Lymphoma; PTCL; HTLV-1

Outcome Measures

Primary Outcomes (1)

• The safety of lenalidomide evaluated based on the severity of adverse events and their causality

  The safety of lenalidomide evaluated based on the severity of adverse events and their causality

  Up to 2.5 years

Secondary Outcomes (9)

• Response

  Up to 2.5 years

• PK-Time to Maximum Plasma Concentration (Tmax)

  Day 8 of Cycle 1

• PK-Apparent Total Body Clearance (CL/F)

  Day 8 of Cycle 1

• PK-Apparent Volume of Distribution (Vz/F)

  Day 8 of Cycle 1

• PK-Terminal half-life (T1/2)

  Day 8 of Cycle 1

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide: 25mg daily on day1-21 of each 28days cycle (1st cohort), 25 mg daily of each 28 days (2nd cohort) or 35 mg daily of each 28 days (3rd cohort)

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide: 25mg daily on day 1-21 of each 28days cycle (1st cohort), 25 mg daily of each 28 days (2nd cohort, or 35 mg daily of each 28 days (3rd cohort)

Lenalidomide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must understand and voluntarily sign the written informed consent;
• Aged 20 years or older;
• Subject have a documented diagnosis of either:
• Acute-, lymphoma-, or unfavorable chronic-type ATL or
• Peripheral T-cell Lymphomaperipheral (PTCL)
• Subject have received ≥1 prior anti-cancer therapy, have achieved stable disease (SD) or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent;
• Subject have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 at enrollment;

You may not qualify if:

• Natural Killer cell lymphoma (NK-cell lymphoma);
• T-cell leukemia;
• Cutaneous T-cell lymphoma (CTCL) including;
• Mycosis fungoides
• Sezary syndrome
• CD30-positive lympho-proliferative disorders
• Cutaneous gamma/delta T-cell lymphoma
• Subject have a history of central nervous system (CNS) involvement or present with CNS symptoms, and are diagnosed with CNS lymphoma by cerebrospinal fluid (CSF) cytology examination, head CT scan or brain MRI during the screening;
• Are pregnant or lactating;
• Subject have uncontrolled inter-current illness including:
• Uncontrolled diabetes mellitus
• Chronic congestive heart failure (NYHA Class III or IV)
• Unstable angina pectoris, angioplasty, stenting, or myocardial infarction (within 6 months before starting the study drug)
• Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia
• Other uncontrolled diseases

Sponsors & Collaborators

• Celgene: lead

Study Sites (6)

National Kyusyu Cancer Center

Fukuoka, 811-1395, Japan

Location

Imamura Bun-in Hospital

Kagoshima, 890-0064, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Nagoya Daini Red Cross Hospital

Nagoya, 466-8650, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Related Publications (1)

• Ogura M, Imaizumi Y, Uike N, Asou N, Utsunomiya A, Uchida T, Aoki T, Tsukasaki K, Taguchi J, Choi I, Maruyama D, Nosaka K, Chen N, Midorikawa S, Ohtsu T, Tobinai K. Lenalidomide in relapsed adult T-cell leukaemia-lymphoma or peripheral T-cell lymphoma (ATLL-001): a phase 1, multicentre, dose-escalation study. Lancet Haematol. 2016 Mar;3(3):e107-18. doi: 10.1016/S2352-3026(15)00284-7. Epub 2016 Feb 12.

  PMID: 26947199 BACKGROUND

MeSH Terms

Conditions

Leukemia-Lymphoma, Adult T-Cell; Lymphoma, T-Cell, Peripheral

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hiroya Asou, MD

  Celgene KK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 20, 2013
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

JP (6)