Trial · NCT01265849

Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity

NCT01265849, Phase 3, Completed, CEL-SCI Corporation; results first posted 2022-08-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity. Trials, record NCT01265849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01265849

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
NCT number: NCT01265849
Status: Completed
Phases: Phase 3
Enrollment: 928 participants, actual
Lead sponsor: CEL-SCI Corporation
Conditions: Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Soft Palate
Interventions: LI, Cyclophosphamide, Indomethacin, Zinc, Surgery, Cisplatin, Radiotherapy
First posted: 2010-12-23
Last updated: 2022-08-19
Other registries' IDs: eudract:2010-019952-35
Results first posted: 2022-08-19

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.	OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility.
Primary	OS in Low Risk Subjects	From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.	OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.
Secondary	Local Regional Control (LRC)	From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.	LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression.
Secondary	LRC in Low Risk Subjects	From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.	LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. Low risk assessment and data analysis was never performed during the study and was done only after database lock.
Secondary	Progression Free Survival (PFS)	From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.	PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.
Secondary	PFS in Low Risk Subjects	From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.	PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Low risk assessment and data analysis was not performed during the study and was performed only after database lock.
Secondary	Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2	Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2	The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale \[GHS\] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100\*\[(RS-1)/6\]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Secondary	Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36	Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36	The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale \[GHS\] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100\*\[(RS-1)/6\]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Secondary	EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2	Baseline [pre-randomization], Long Term Follow-up Month 2	The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head \& neck cancer module (EORTC QLQ-C30 - QLQ H\&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100\*\[(RS-1)/3\]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Secondary	EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36	Baseline [pre-randomization], Long Term Follow-up Month 36	The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head \& neck cancer module (EORTC QLQ-C30 - QLQ H\&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100\*\[(RS-1)/3\]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.	Intent to Treat Population	months	MEDIAN
PRIMARY	OS in Low Risk Subjects	From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.	Low Risk Intent to Treat Population	months	MEDIAN
SECONDARY	Local Regional Control (LRC)	From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.	Intent to treat population	months	MEDIAN
SECONDARY	LRC in Low Risk Subjects	From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.	Low Risk Intent to Treat Population	months	MEDIAN
SECONDARY	Progression Free Survival (PFS)	From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.	Intent to Treat Population	months	MEDIAN
SECONDARY	PFS in Low Risk Subjects	From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.	Low Risk Intent to treat population	months	MEDIAN
SECONDARY	Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2	Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2	Overall number of participants analyzed is the total number of subjects in the longitudinal model.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons.	units on a scale (0-100)	LEAST_SQUARES_MEAN
SECONDARY	Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36	Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36	Overall number of participants analyzed is the total number of subjects with data at this visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons.	units on a scale (0-100)	LEAST_SQUARES_MEAN
SECONDARY	EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2	Baseline [pre-randomization], Long Term Follow-up Month 2	Overall number of participants analyzed is the total number of subjects in data at that visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons.	units on a scale (0-100)	LEAST_SQUARES_MEAN
SECONDARY	EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36	Baseline [pre-randomization], Long Term Follow-up Month 36	Overall number of participants analyzed is the total number of subjects with data at this visit.~The number of participants analyzed is the number of subjects assessed at each visit.~This study is not powered for quality of life comparisons.	units on a scale (0-100)	LEAST_SQUARES_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group92

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	LI + CIZ + SOC	46.3	95% Confidence Interval 39.3 to 55.0	months
Overall Survival (OS)	LI + SOC	58.1	95% Confidence Interval 41.4 to 68.2	months
Overall Survival (OS)	Standard of Care (SOC)	52.9	95% Confidence Interval 46.5 to 66.6	months
OS in Low Risk Subjects	LI + CIZ + SOC	101.7	95% Confidence Interval 64.1 to 101.7	months
OS in Low Risk Subjects	LI + SOC	68.2	95% Confidence Interval 44.7 to NA	months
OS in Low Risk Subjects	Standard of Care (SOC)	55.2	95% Confidence Interval 48.0 to NA	months
Local Regional Control (LRC)	LI + CIZ + SOC	NA	95% Confidence Interval NA to NA	months
Local Regional Control (LRC)	LI + SOC	NA	95% Confidence Interval NA to NA	months
Local Regional Control (LRC)	Standard of Care (SOC)	NA	95% Confidence Interval NA to NA	months
LRC in Low Risk Subjects	LI + CIZ + SOC	NA	95% Confidence Interval NA to NA	months

1 to 10 of 92Source ClinicalTrials.gov

See all 92 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LI + CIZ + SOC	396
Overall Study	STARTED	Standard of Care (SOC)	398
Overall Study	STARTED	LI + SOC	134
Overall Study	COMPLETED	LI + CIZ + SOC	350
Overall Study	COMPLETED	Standard of Care (SOC)	337
Overall Study	COMPLETED	LI + SOC	115
Overall Study	NOT COMPLETED	LI + CIZ + SOC	46
Overall Study	NOT COMPLETED	Standard of Care (SOC)	61
Overall Study	NOT COMPLETED	LI + SOC	19

Source ClinicalTrials.gov

Adverse events711

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	LI + CIZ + SOC	64	383
other	Anaemia	Blood and lymphatic system disorders	LI + SOC	26	129
other	Anaemia	Blood and lymphatic system disorders	Standard of Care (SOC)	68	367
other	Leukopenia	Blood and lymphatic system disorders	LI + CIZ + SOC	36	383
other	Leukopenia	Blood and lymphatic system disorders	LI + SOC	12	129
other	Leukopenia	Blood and lymphatic system disorders	Standard of Care (SOC)	32	367
other	Neutropenia	Blood and lymphatic system disorders	LI + CIZ + SOC	33	383
other	Neutropenia	Blood and lymphatic system disorders	LI + SOC	8	129
other	Neutropenia	Blood and lymphatic system disorders	Standard of Care (SOC)	36	367
other	Constipation	Gastrointestinal disorders	LI + CIZ + SOC	29	383

1 to 10 of 711Source ClinicalTrials.gov

See all 711 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LI + CIZ + SOC	204	395
Total, all-cause mortality	LI + SOC	68	134
Total, all-cause mortality	Standard of Care (SOC)	190	394
Total, other adverse events	LI + CIZ + SOC	354	383
Total, other adverse events	LI + SOC	124	129
Total, other adverse events	Standard of Care (SOC)	352	367
Total, serious adverse events	LI + CIZ + SOC	216	383
Total, serious adverse events	LI + SOC	70	129
Total, serious adverse events	Standard of Care (SOC)	187	367

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40191245	DERIVED	PubMed
42537452	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01265849

GET https://conductscience.org/api/trials/v1/NCT01265849/results?page=2

API reference For AI assistants