Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

• Sponsor: Kyowa Hakko Kirin Pharma, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01226472
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.

Condition or Disease	Intervention/Treatment	Phase
Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma	Biological: KW-0761	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KW-0761	Biological: KW-0761; In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.

Outcome Measures

Primary Outcome Measures

1. Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging [one year]

Secondary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability. [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.

1. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of < 2 at study entry.

2. The subject is >18 years of age. 4. The subject has adequate hematological function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000 cells/uL,except in patients with known bone marrow involvement where absolute neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.

3. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.

4. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance

60 mL/min.

1. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.

Exclusion Criteria:

1. The subject has received any type of treatment for their disease since completing study, KW-0761-001.

2. The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.

3. Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone

4. The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements.

5. The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.

6. Subjects with active herpes simplex or herpes zoster.

7. Subjects with known autoimmune diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Kyowa Hakko Kirin Pharma, Inc.

Investigators

• Study Director: Michael Kurman, M.D., Kyowa Hakko Kirin Pharma, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT01226472
• Other Study ID Numbers: KW-0761-002
• First Posted: Oct 22, 2010
• Last Update Posted: Dec 29, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Kyowa Hakko Kirin Pharma, Inc.: PTCL; CTCL; MF; SS
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Mogamulizumab

Study Results

Participant Flow

Arm/Group Title	KW-0761
Arm/Group Description	KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	KW-0761
Arm/Group Description	KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	1 100%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Race/Ethnicity, Customized (Count of Participants)
White, Hispanic or Latino	1 100%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Time Frame	one year

Outcome Measure Data

Analysis Population Description

Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).

Arm/Group Title	KW-0761
Arm/Group Description	KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Measure Participants	1
Progression-Free Survival (PFS)	260
Time to Progression (TTP)	260
Duration of Overall Response (DR)	232

2. Secondary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	KW-0761
Arm/Group Description	KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Measure Participants	1
With Any TEAE	1 100%
With Any Drug-related TEAE	0 0%
With Any TEAE with an Outcome of Death	0 0%
With Any Serious TEAE	0 0%
With Any Drug-related Serious TEAE	0 0%
With Any Serious TEAE with an Outcome of Death	0 0%

Adverse Events

Arm/Group Title	KW-0761
Arm/Group Description	KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
All Cause Mortality
	KW-0761
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	KW-0761
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	KW-0761
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Metabolism and nutrition disorders
Hypophosphataemia	1/1 (100%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.