Trial Outcomes & Findings for Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma (NCT NCT01007526)

Results Overview

Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Within 3 weeks after the completion fo treatment

Results posted on

2019-02-07

Participant Flow

Recruitment between August 2008 and October 2010 Location: University hospital or Institutes

Participant milestones

Participant milestones
Measure	CCRT Plus VIDL CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CCRT Plus VIDL n=31 Participants CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	47.1 years STANDARD_DEVIATION 12.7 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants
Region of Enrollment Korea, Republic of	31 participants n=99 Participants

PRIMARY outcome

Timeframe: Within 3 weeks after the completion fo treatment

Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease

Outcome measures

Outcome measures
Measure	CCRT Plus VIDL n=31 Participants CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Compete Response Rate	31 participants

SECONDARY outcome

Timeframe: Up to 5 years after the completion of treatment

Outcome measures

Outcome data not reported

Adverse Events

CCRT Plus VIDL

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CCRT Plus VIDL n=30 participants at risk；n=31 participants at risk CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Blood and lymphatic system disorders Neutropenia	100.0% 30/30 • Number of events 30 • 6 months after registration We applied the same definition as the clinicaltrials.gov.

Additional Information

Won Seog Kim

Samsung Medical Center

Phone: 82234106548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place