Trial Outcomes & Findings for Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides (NCT NCT01187446)

Last Updated: 2017-11-20

Results Overview

Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Week 8

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	TSEBT Only • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day continuing for 8 weeks total.
Overall Study STARTED	14	14
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TSEBT Only • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day continuing for 8 weeks total.
Overall Study Patient started non-protocol therapy	0	1

Baseline Characteristics

Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=14 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Clinical Stage Mycosis fungoides, Stage IB	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Clinical Stage Mycosis fungoides, Stage IIA	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Clinical Stage Mycosis fungoides, Stage IIB	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Clinical Stage Mycosis fungoides, Stage IIIB	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=13 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Complete Clinical Response (CCR)	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.

Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.

Outcome measures

Outcome measures
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=13 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Alopecia	7 Number of patients	10 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Fatigue	4 Number of patients	10 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Extremity Pain	9 Number of patients	6 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Nausea	0 Number of patients	8 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Skin Pain	1 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Vomiting	0 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Xerosis/Dry Skin	1 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Dysgeusia	0 Number of patients	4 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Nail Changes	4 Number of patients	1 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Diarrhea	0 Number of patients	3 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Ocular Irritation	0 Number of patients	3 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Radiation Dermatitis	1 Number of patients	3 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Thrombocytopenia	0 Number of patients	3 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Anorexia	0 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Dizziness	0 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Lymphopenia	0 Number of patients	2 Number of patients
Safety and Tolerability as Measured by Severity and Frequency of Adverse Events Pedal Edema	2 Number of patients	1 Number of patients

SECONDARY outcome

Timeframe: Week 8

Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate. CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to \<100% clearance of skin disease as measured by \> 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD PD = Whichever is met first of: 1. \> 25% increase in skin disease from baseline as measured by \> 25% increase of mSWAT score compared with baseline 2. New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or 3. In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of \> \[nadir + \> 50% of baseline\] 4. Relapse applies to any new disease after confirmed CR

Outcome measures

Outcome measures
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=13 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Clinical Response Rate (CRR) Partial Response	8 Participants	10 Participants
Clinical Response Rate (CRR) Stable Disease	3 Participants	0 Participants
Clinical Response Rate (CRR) Complete Response (CR)	3 Participants	3 Participants
Clinical Response Rate (CRR) Progressive Disease	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks after completion of treatment

Population: The data are reported for the per-protocol period of follow-up (48 weeks).

Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks)

Outcome measures

Outcome measures
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=13 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Duration of Clinical Benefit (Per Protocol Follow-up)	48 Weeks Interval 9.6 to 48.0	28 Weeks Interval 5.7 to 48.0

SECONDARY outcome

Timeframe: 140 weeks

Population: The data are reported for the full period for which participant data are available.

Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment.

Outcome measures

Outcome measures
Measure	TSEBT Only n=14 Participants • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.	TSEBT Plus Vorinostat n=13 Participants * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. * Vorinostat 400 mg/day concurrent and continuing for 8 weeks total.
Duration of Clinical Benefit (Supplemental Follow-up)	125 weeks Interval 9.6 to 135.1	28 weeks Interval 5.7 to 82.0

Adverse Events

TSEBT Only

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

TSEBT & Vorinostat

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TSEBT Only n=14 participants at risk TSEBT (12Gy) per institutional guidelines.	TSEBT & Vorinostat n=14 participants at risk TSEBT (12Gy) per institutional guidelines. Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT.
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.

Other adverse events

Additional Information

Youn H Kim, MD

Stanford University Medical Center

Phone: 650-521-3545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TSEBT Only n=14 participants at risk TSEBT (12Gy) per institutional guidelines.	TSEBT & Vorinostat n=14 participants at risk TSEBT (12Gy) per institutional guidelines. Vorinostat 400 mg daily starting one day prior to the initiation of TSEBT.
Skin and subcutaneous tissue disorders Abscess of Head and Neck	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Actinic Keratosis	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Alopecia	50.0% 7/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	71.4% 10/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Anemia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Psychiatric disorders Anorexia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Blistering of Feet	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Blistering of Lip	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Constipation	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Diarrhea	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	21.4% 3/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Dizziness	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Dry Mouth	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Dysgeusia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	28.6% 4/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Dyspepsia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Elevated Bilirubin	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Elevated Creatinine	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Extremity Pain	64.3% 9/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	71.4% 10/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Eye Pain	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Fatigue	28.6% 4/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	71.4% 10/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Hypomagnesemia	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Hyponatremia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Jaw Pain	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Leucopenia	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Nail Changes	28.6% 4/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Nausea	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	57.1% 8/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Neutropenia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Eye disorders Ocular Irritation	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	21.4% 3/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Oral Pain (Lips/Cheilitis)	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Oral Ulcer	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Pedal Edema	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Peeling of Skin on Limbs	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Radiation Dermatitis	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	21.4% 3/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Skin Infection	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Skin Pain	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Skin Ulceration	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	21.4% 3/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
General disorders Vomiting	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Xerosis/Dry Skin	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	14.3% 2/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.
Skin and subcutaneous tissue disorders Gynecomastia	0.00% 0/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.	7.1% 1/14 • Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.