Trial Outcomes & Findings for Phase II Study of TAK228 in Relapsed Lymphoma (NCT NCT02727777)

Last Updated: 2020-03-12

Results Overview

RA was defined by Lugano Criteria \& based on CT scans obtained at screening \& after completion of every 2 cycles of therapy. Complete Radiographic Response Target Nodes must regress to \<=1.5cm in longest dimension,No extralymphatic sites of disease. PR \>=50% decrease in sum of the product of diameters of up to 6 target measurable nodes and extranodal sites. When a lesion is too small to measure on CT, 5 mmx5mm is assigned. When not visible on CT, assign 0x0 mm. For a node 5mmx5mm use actual measurement. SD\< 50% decrease in sum of the product of diameters of up to 6 target measurable nodes \& extranodal sites, no criteria for disease progression are met. Progressive disease requires one of the following:An individual node must be abnormal with: LDi 1.5cm \& Increase by 50% from PPD nadir \& an increase in LDi or SDi from nadir 0.5cm for lesions 2cm,1cm for lesions 2cm. In case of splenomegaly, the splenic length must increase by \>=50% of the extent of its prior increase beyond baseline.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Time frame for response assessment was from Baseline to end of treatment or progression of disease up to 1 year.

Results posted on

2020-03-12

Participant Flow

Recruitment was open from 03/01/2017 to 11/27/2017

No significant events in the study occurred after enrollment, prior to assignment to arm/group

Participant milestones

Participant milestones
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma
Overall Study STARTED	4	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma
Overall Study Screen Failure	2	0	0
Overall Study Progressive disease	2	0	0

Baseline Characteristics

Phase II Study of TAK228 in Relapsed Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr n=4 Participants Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	—	—	3 Participants n=7 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	—	—	3 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	—	—	4 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	—	—	1 Participants n=7 Participants
Region of Enrollment United States	4 Participants n=99 Participants	—	—	4 Participants n=7 Participants

PRIMARY outcome

Timeframe: Time frame for response assessment was from Baseline to end of treatment or progression of disease up to 1 year.

Population: No analysis could be performed due to 2 participants failed screening and 2 participants disease progressed before analysis could be performed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of treatment or progression of disease

Population: Adverse events were evaluated for the time patients were on study however due to early progression of disease, patients did not finish the treatment and adverse events reported were not conclusive of toxicity related to drug. Updated to two participants for the secondary outcome.

Progression free survival, duration of response and overall survival analysis could not be properly evaluated due to patients being taken off study early due to progression of disease but safety and tolerability were reported through safety event reports, please see AEs-serious and non-serious section for this.

Outcome measures

Outcome measures
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr n=2 Participants Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma
Number of Participants With Adverse Events	2 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to end of treatment or progression of disease

Population: Exploratory objective was not analyzed because patients came off study before it could be analyzed, no data were collected.

Assessed with reverse phase protein arrays after exposure to TAK228,

Outcome measures

Outcome data not reported

Adverse Events

Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Indolent NHL:FL grade1-3a,SLL,MZL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hodgkin Lymphoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr n=2 participants at risk Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma
Skin and subcutaneous tissue disorders Cellulitis	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.

Other adverse events

Other adverse events
Measure	Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr n=2 participants at risk Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b	Indolent NHL:FL grade1-3a,SLL,MZL Indolent NHL:FL grade1-3a,SLL,MZL	Hodgkin Lymphoma Hodgkin lymphoma
General disorders Edema Limbs	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Blood and lymphatic system disorders Bacteremia	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Infections and infestations Urinary Tract infection	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
General disorders Fatigue	100.0% 2/2 • Number of events 2 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Renal and urinary disorders Renal insufficiency	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Metabolism and nutrition disorders Hyperuricemia	100.0% 2/2 • Number of events 2 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Metabolism and nutrition disorders Anorexia/appetite change	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Musculoskeletal and connective tissue disorders Pain in extremity (right thigh)	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Skin and subcutaneous tissue disorders Pruritis	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Eye disorders Blurred vision	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.
Gastrointestinal disorders Abdominal Pain	50.0% 1/2 • Number of events 1 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.	— 0/0 • The time frame for assessment of adverse events was from time of consent to the end of treatment or progression of disease, whichever occurred first. Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.

Additional Information

Dr. Jason R. Westin/Lymphoma/Myeloma

UT MD Anderson Cancer Center

Phone: 713-792-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place