KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
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|ClinicalTrials.gov Identifier: NCT01626664|
Recruitment Status : Completed
First Posted : June 25, 2012
Results First Posted : June 15, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult T-cell Leukemia-Lymphoma||Biological: KW-0761 Drug: Pralatrexate Drug: gemcitabine plus oxaliplatin Drug: DHAP||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||February 2018|
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Active Comparator: investigator's choice
Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
Other Name: Folotyn
Drug: gemcitabine plus oxaliplatin
gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
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
- Overall Response Rate [ Time Frame: every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first ]
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.
- Progression Free Survival [ Time Frame: 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 ]Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.
- Overall Survival [ Time Frame: up to 36 months ]The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group.
- Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score [ Time Frame: From date of randomization until the date of first documented progression, up to 36 months ]The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626664
|Study Director:||Michael Kurman, MD||Kyowa Hakko Kirin Pharma, Inc.|