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

NCT ID: NCT01169298

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-01
• Study Completion Date: 2013-12-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide

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)

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: 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)

Interventions

Lenalidomide

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject must understand and voluntarily sign the written informed consent;

2. Aged 20 years or older;

3. Subject have a documented diagnosis of either:

• Acute-, lymphoma-, or unfavorable chronic-type ATL or
• Peripheral T-cell Lymphomaperipheral (PTCL)

4. 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;

5. Subject have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 at enrollment;

Exclusion Criteria

1. Natural Killer cell lymphoma (NK-cell lymphoma);

2. T-cell leukemia;

3. Cutaneous T-cell lymphoma (CTCL) including;

• Mycosis fungoides
• Sezary syndrome
• CD30-positive lympho-proliferative disorders
• Cutaneous gamma/delta T-cell lymphoma

4. 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;

5. Are pregnant or lactating;

6. 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

7. Exhibit grade 4 neurological disorders;

8. Subject have a history or complication of deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment;

9. Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs;

10. Are tested positive for HBs antigen, anti-HCV antibody, or anti-HIV antibody;

11. Subjects have a history or complication for which the investigator or subinvestigator deems them inappropriate for this study, or have serious diseases or mental illness that is likely to be aggravated by participation in this study;

12. Subjects have a history of allogeneic stem cell transplantation;

13. Subjects have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment;

14. Have previously used lenalidomide;

15. Have a history of desquamating (bullous) rash while taking thalidomide;

16. Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication;

17. Have received chemotherapeutic agents or immunomodulators for the treatment of ATL or PTCL within 4 weeks (28 days) of the start of study treatment;

18. Have received radiotherapy within 4 weeks (28 days) of the start of study treatment;

19. Have a history or complication of another malignant tumor than ATL or PTCL (excluding malignant tumors below), unless the patients have been free of the disease for 5 years or longer;

• Cutaneous basal cell carcinoma or squamous cell carcinoma
• Cervical carcinoma in situ
• An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)

20. Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the enrollment;

• Neutrophil count: < 1,200/µL (1.2 x 109/L)
• Platelet count: < 75,000/µL (75 x 109/L)
• Serum aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT) or Alanine transaminase/Serum Glutamic Pyruvate Transaminase (ALT/SGPT): > 3 times the Upper Limit of Normal (ULN)
• Bilirubin level: > 1.5 times of the ULN
• Creatinine clearance: < 60 mL/min

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroya Asou, MD

Role: STUDY_DIRECTOR

Celgene KK

Locations

National Kyusyu Cancer Center

Fukuoka, , Japan

Imamura Bun-in Hospital

Kagoshima, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Nagoya Daini Red Cross Hospital

Nagoya, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 26947199 (View on PubMed)

Other Identifiers

CC-5013-ATLL-001

Identifier Type: -

Identifier Source: org_study_id