Trial Outcomes & Findings for Stage I/II Nasal NK Cell Lymphoma (NCT NCT01321008)

Results Overview

Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Day 1 to disease progression or death (up to 5+ years)

Results posted on

2015-02-05

Participant Flow

Recruitment Period: May 20, 2011 to May 8, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.

Study was terminated early due to extensive revisions to the study.

Participant milestones

Participant milestones
Measure	Radiation + Chemotherapy Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation + Chemotherapy Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Overall Study Early Study Termination	1

Baseline Characteristics

Stage I/II Nasal NK Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation + Chemotherapy n=1 Participants Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to disease progression or death (up to 5+ years)

Population: Study terminated early, no analysis available.

Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.

Outcome measures

Outcome data not reported

Adverse Events

Radiation + Chemotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiation + Chemotherapy n=1 participants at risk Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Skin and subcutaneous tissue disorders Erythema Multiforme	100.0% 1/1 • Number of events 1 • Adverse Event (AE) monitoring during study participation from baseline to completion of 4 cycles, each 21 days. Serious AEs monitored until resolved or clearly determined to be due to stable or chronic condition or intercurrent illness(es). Collection Period: March 28, 2012 to May 01, 2013.
Infections and infestations Sinus Disorder	100.0% 1/1 • Number of events 1 • Adverse Event (AE) monitoring during study participation from baseline to completion of 4 cycles, each 21 days. Serious AEs monitored until resolved or clearly determined to be due to stable or chronic condition or intercurrent illness(es). Collection Period: March 28, 2012 to May 01, 2013.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Adverse Event (AE) monitoring during study participation from baseline to completion of 4 cycles, each 21 days. Serious AEs monitored until resolved or clearly determined to be due to stable or chronic condition or intercurrent illness(es). Collection Period: March 28, 2012 to May 01, 2013.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	100.0% 1/1 • Number of events 1 • Adverse Event (AE) monitoring during study participation from baseline to completion of 4 cycles, each 21 days. Serious AEs monitored until resolved or clearly determined to be due to stable or chronic condition or intercurrent illness(es). Collection Period: March 28, 2012 to May 01, 2013.

Additional Information

Bouthaina Dabaja, MD / Associate Professor, Radiation Oncology

University of Texas MD Anderson Cancer Center

Phone: 713-563-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place