KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

NCT01626664 | Completed Phase 2 Results

• 1 other identifier: PROTOCOL 0761-009
• Study Type: interventional
• Target: 71
• Locations: 6 countries
• Sites: 20

Brief Summary

The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

Conditions

Adult T-cell Leukemia-Lymphoma

Keywords

Adult T cell Leukemia-Lymphoma (ATL)

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = \> 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment. Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment.

  every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Secondary Outcomes (3)

• Progression Free Survival

  From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months

• Overall Survival

  up to 36 months

• Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score

  From date of randomization until the date of first documented progression, up to 36 months

Study Arms (2)

KW-0761

EXPERIMENTAL

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

Biological: KW-0761

investigator's choice

ACTIVE COMPARATOR

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Drug: Pralatrexate; Drug: gemcitabine plus oxaliplatin; Drug: DHAP

Interventions

KW-0761 BIOLOGICAL

1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Also known as: mogamulizumab, POTELIGEO®

KW-0761

Pralatrexate DRUG

30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

Also known as: Folotyn

investigator's choice

gemcitabine plus oxaliplatin DRUG

gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

Also known as: Gemzar, Eloxatin, GemOx

investigator's choice

DHAP DRUG

dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Also known as: Decadron, Dexasone, Baycadron, Platinol, Depocyt, Ara-C

investigator's choice

Eligibility Criteria

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

You may qualify if:

• Males and female subjects ≥ 18 years of age
• Confirmed diagnosis of ATL (excluding smoldering subtype)
• Subjects must currently have evidence of disease in at least one of the following:
• Lymph nodes
• Extranodal masses
• Spleen or liver
• Skin
• Peripheral blood
• Bone marrow
• Relapsed or refractory after at least one prior systemic therapy regimen for ATL;
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry
• Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
• Adequate hematological, hepatic and renal function

You may not qualify if:

• Smoldering subtype of ATL;
• Lymphomatous or acute subtype subject with \> 2 prior systemic therapy regimens and who has not achieved a response (CR or PR) or maintained stable disease for at least 12 weeks on last immediate prior therapy;
• History of allogeneic transplant;
• Autologous hematopoietic stem cell transplant within 90 days of study entry;
• Untreated human immunodeficiency virus (HIV)
• Has known hepatitis C. Patients who are hepatitis C antibody positive but are hepatitis C quantitative PCR negative may be enrolled;
• Has hepatitis B based on PCR testing for hepatitis B virus DNA. Patients who are hepatitis B core antibody positive but PCR negative may be enrolled if placed on appropriate anti-hepatitis B virus prophylaxis prior to commencing treatment with KW-0761. Patients who are hepatitis B core antibody positive based on prior vaccination need not receive prophylaxis;
• Have had a malignancy in the past two years except non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA \< 0.1 µg/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease;
• Clinical evidence of central nervous system (CNS) involvement or metastasis. In subjects suspected of having CNS disease, an MRI of the brain and/or lumbar puncture should be done to confirm;
• Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements;
• Significant uncontrolled intercurrent illness
• Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
• Known active autoimmune diseases will be excluded (For example; Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
• Is pregnant (confirmed by beta human chorionic gonadotrophin \[β-HCG\]) or lactating.
• Prior treatment with KW-0761;

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (20)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Miami / Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering

New York, New York, 10021, United States

Location

Columbia Presbyterian

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hospital Universitario Professor Edgard Santos- UFBA

Salvador, Bahia, 40110-060, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Sao Paulo- SP, CEP 05403-000, Brazil

Location

CHU de Fort de France

Fort de France Cedex, BP 632 97261, France

Location

Hospital Necker

Paris, 75743, France

Location

Hospital Nacional Edgardo Rebagliati Martins

Lima, Lima11, Peru

Location

Instituto Oncologico Miraflores

Lima, Lima18, Peru

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Imperial College

London, W2 1PG, United Kingdom

Location

Sandwell General Hospital

West Midlands, B71 4HJ, United Kingdom

Location

MeSH Terms

Conditions

Leukemia-Lymphoma, Adult T-Cell; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

mogamulizumab; 10-propargyl-10-deazaaminopterin; Gemcitabine; Oxaliplatin; Calcium Dobesilate; Dexamethasone; Cisplatin; Cytarabine

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; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Fiona Herr, Associate Director, Medical Communications
• Organization: Kyowa Kirin Inc

medinfo-US@kyowakirin.com

1 (908) 234-1096

Study Officials

• Michael Kurman, MD

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2018
• Last Updated: April 25, 2024
• Results First Posted: June 15, 2018

Record last verified: 2024-04

Locations

BE (1); PE (2); BR (2); US (10); FR (2); GB (3)