A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

NCT01724177 | Completed Phase 2 Results DMC

• 1 other identifier: CC-5013-ATLL-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 18

Brief Summary

To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Conditions

Adult T-Cell Leukemia-Lymphoma

Keywords

Lenalidomide; ATL; ATLL

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)

  ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared

  From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Secondary Outcomes (6)

• Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC

  From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks

• Kaplan-Meier Estimate of Time to Progression (TTP)

  From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks

• Number of Participants With Treatment Emergent Adverse Events

  From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks

• Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC

  From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks

• Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC

  From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Other Outcomes (1)

• Time to Response

  From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

25 mg of Lenalidomide administered orally once daily

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Must understand and voluntarily sign the informed consent
• Aged 20 years or older (at the time of signing the informed consent)
• Have a documented diagnosis of either: acute-, lymphoma-, or unfavorable chronic-type adult T-cell leukemia-lymphoma
• Have received ≥1 prior anti-adult T-cell leukemia-lymphoma therapy, have achieved stable disease or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent
• Subjects for whom at least 1 measurable lesion (measurable lesion of computed tomography scan, peripheral blood or skin lesion) is confirmed in the lesion assessment before registration
• Have an Eastern Cooperative Oncology Group performance status of 0 to 2 at registration
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

You may not qualify if:

• Have a history of central nervous system involvement or present with central nervous system symptoms, and are diagnosed with central nervous system lymphoma by cerebrospinal fluid cytology examination, head computed tomography scan or brain magnetic resonance imaging during the screening
• Are pregnant or lactating
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. Examples of such medical condition are, but are not limited to, as follows:
• Uncontrolled diabetes mellitus as defined by the investigator or sub-investigator
• Chronic congestive heart failure (New York Heart Association 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 (subjects with controlled atrial fibrillation that is asymptomatic are eligible for this study)
• Major surgery within 28 days of the start of study treatment
• Exhibit grade 4 neurological disorders
• Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic prophylaxis.
• Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs
• Known human immunodeficiency virus positivity
• Have hepatitis B surface antigen-positive, or hepatitis C virus anti-body positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus deoxyribonucleic acid test should be performed and if positive the subject will be excluded
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
• Have a history of allogenic stem cell transplantation

Sponsors & Collaborators

• Celgene: lead

Study Sites (18)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Sasebo City General Hospital

Sasebo, Nagasaki, 857-8511, Japan

Location

Heart Life Hospital

Nakagami, Okinawa, 901-2492, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Imamura Bunin Hospital

Kagoshima, 890-0064, Japan

Location

Kagoshima University Medical and Dental Hospital

Kagoshima, 890-8520, Japan

Location

National Hospital Organization Kagoshima Medical Center

Kagoshima, 892-0853, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

The Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, 852-8511, Japan

Location

Oita Prefectual Hospital

Ōita, 870-8511, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Related Publications (1)

• Ishida T, Fujiwara H, Nosaka K, Taira N, Abe Y, Imaizumi Y, Moriuchi Y, Jo T, Ishizawa K, Tobinai K, Tsukasaki K, Ito S, Yoshimitsu M, Otsuka M, Ogura M, Midorikawa S, Ruiz W, Ohtsu T. Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002. J Clin Oncol. 2016 Dec;34(34):4086-4093. doi: 10.1200/JCO.2016.67.7732. Epub 2016 Sep 30.

  PMID: 27621400 RESULT

MeSH Terms

Conditions

Leukemia-Lymphoma, Adult T-Cell

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

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

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

1-888-260-1599

Study Officials

• Toru Sasaki

  Celgene K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: November 12, 2012
• Primary Completion: November 20, 2014
• Study Completion: March 21, 2017
• Last Updated: May 29, 2018
• Results First Posted: January 5, 2016

Record last verified: 2018-03

Locations

JP (18)