Trial · NCT01626664

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

NCT01626664, Phase 2, Completed, Kyowa Kirin, Inc.; results first posted 2018-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL). Trials, record NCT01626664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01626664

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
NCT number: NCT01626664
Status: Completed
Phases: Phase 2
Enrollment: 71 participants, actual
Lead sponsor: Kyowa Kirin, Inc.
Conditions: Adult T-cell Leukemia-Lymphoma
Interventions: KW-0761, Pralatrexate, gemcitabine plus oxaliplatin, DHAP
First posted: 2012-06-25
Last updated: 2024-04-25
Results first posted: 2018-06-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate	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.
Secondary	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	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.
Secondary	Overall Survival	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.
Secondary	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	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first		participants	NUMBER
SECONDARY	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		percentage of subjects	MEDIAN
SECONDARY	Overall Survival	up to 36 months		percentage of subjects	MEDIAN
SECONDARY	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	All participants in Intention-to-Treat who had both the values at baseline and last observation	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overall Response Rate	KW-0761	Complete Response	2	participants
Overall Response Rate	Investigator's Choice	Complete Response	0	participants
Overall Response Rate	KW-0761	Uncertified Complete Response	0	participants
Overall Response Rate	Investigator's Choice	Uncertified Complete Response	0	participants
Overall Response Rate	KW-0761	Partial Response	11	participants
Overall Response Rate	Investigator's Choice	Partial Response	2	participants
Overall Response Rate	KW-0761	Stable Disease	0	participants
Overall Response Rate	Investigator's Choice	Stable Disease	4	participants
Overall Response Rate	KW-0761	Relapsed Disease or Progressive Disease	16	participants
Overall Response Rate	Investigator's Choice	Relapsed Disease or Progressive Disease	13	participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization Period	STARTED	KW-0761	47
Randomization Period	STARTED	Investigator's Choice	24
Randomization Period	STARTED	IC Original Then Crossover to KW-0761	0
Randomization Period	COMPLETED	KW-0761	47
Randomization Period	COMPLETED	Investigator's Choice	24
Randomization Period	COMPLETED	IC Original Then Crossover to KW-0761	0
Randomization Period	NOT COMPLETED	KW-0761	0
Randomization Period	NOT COMPLETED	Investigator's Choice	0
Randomization Period	NOT COMPLETED	IC Original Then Crossover to KW-0761	0
Crossover Period	STARTED	KW-0761	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events573

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	KW-0761	10	47	13
other	Anaemia	Blood and lymphatic system disorders	Investigator's Choice	3	24	10
other	Anaemia	Blood and lymphatic system disorders	IC Original Then Crossover to KW-0761	6	18	11
other	Leukocytosis	Blood and lymphatic system disorders	KW-0761	0	47	0
other	Leukocytosis	Blood and lymphatic system disorders	Investigator's Choice	0	24	0
other	Leukocytosis	Blood and lymphatic system disorders	IC Original Then Crossover to KW-0761	2	18	2
other	Leukopenia	Blood and lymphatic system disorders	KW-0761	3	47	3
other	Leukopenia	Blood and lymphatic system disorders	Investigator's Choice	1	24	1
other	Leukopenia	Blood and lymphatic system disorders	IC Original Then Crossover to KW-0761	0	18	0
other	Neutropenia	Blood and lymphatic system disorders	KW-0761	4	47	10

1 to 10 of 573Source ClinicalTrials.gov

See all 573 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KW-0761	10	47
Total, all-cause mortality	Investigator's Choice	1	24
Total, all-cause mortality	IC Original Then Crossover to KW-0761	12	18
Total, other adverse events	KW-0761	45	47
Total, other adverse events	Investigator's Choice	24	24
Total, other adverse events	IC Original Then Crossover to KW-0761	17	18
Total, serious adverse events	KW-0761	26	47
Total, serious adverse events	Investigator's Choice	10	24
Total, serious adverse events	IC Original Then Crossover to KW-0761	9	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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