Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01169298
Other study ID # CC-5013-ATLL-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2010
Est. completion date December 20, 2013

Study information

Verified date November 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 20, 2013
Est. primary completion date December 1, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Drug:
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)

Locations

Country Name City State
Japan 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

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Response The response of ATL patient to lenalidomide will be evaluated according to the criteria proposed by the International Consensus Meeting.
The response of PTCL will be assessed by the Japan Clinical Oncology Group (JCOG) response criteria that have been established by the Lymphoma Study Group of the JCOG based on criteria of Cheson et al.in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas
Up to 2.5 years
Secondary PK-Time to Maximum Plasma Concentration (Tmax) PK-Time to Maximum Plasma Concentration (Tmax) Day 8 of Cycle 1
Secondary PK-Apparent Total Body Clearance (CL/F) PK-Apparent Total Body Clearance (CL/F) Day 8 of Cycle 1
Secondary PK-Apparent Volume of Distribution (Vz/F) PK-Apparent Volume of Distribution (Vz/F) Day 8 of Cycle 1
Secondary PK-Terminal half-life (T1/2) PK-Terminal half-life (T1/2) Day 8 of Cycle 1
Secondary PK-Area under the Plasma concentration time curve (AUC) PK-Area under the Plasma concentration time curve (AUC) Day 8 of Cycle 1
Secondary Accumulation ratio (Cmax) Accumulation ratio (Cmax) Day 8 of Cycle 1
Secondary Accumulation ratio (AUCt) Accumulation ratio (AUCt) Day 8 of Cycle 1
Secondary PK-Maximum Concentration in Plasma (Cmax) PK-Maximum Concentration in Plasma (Cmax) Day 8 of cycle 1
See also
  Status Clinical Trial Phase
Completed NCT00038025 - A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies Phase 2
Recruiting NCT02445404 - Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL Phase 2
Completed NCT02168140 - CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma Phase 1
Completed NCT01689220 - A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea Phase 1
Terminated NCT01644253 - Phase 1b Safety and Efficacy Study of TRU-016 Phase 1
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT01435863 - A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) Phase 1
Terminated NCT00441025 - The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Active, not recruiting NCT04312841 - Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab Phase 2
Recruiting NCT04040491 - PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma Phase 4
Terminated NCT01678443 - Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Phase 1
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT02142530 - Carfilzomib Plus Belinostat in Relapsed/Refractory NHL Phase 1
Completed NCT02264613 - ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas Phase 1/Phase 2
Terminated NCT01408043 - Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma N/A
Completed NCT00131937 - Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma Phase 2
Completed NCT00791947 - A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT Phase 2
Recruiting NCT04880746 - Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study Phase 3