Trial Outcomes & Findings for A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma (NCT NCT00337987)

Last Updated: 2015-02-27

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

After 4 years

Results posted on

2015-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Denileukin Diftitox/CHOP Administration Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Denileukin Diftitox/CHOP Administration n=49 Participants Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 4 years

Outcome measures

Outcome measures
Measure	Denileukin Diftitox/CHOP Administration n=49 Participants Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Number of Patients That Achieved a Complete Response or a Partial Response (PR)	32 participants

PRIMARY outcome

Timeframe: After 4 years

Outcome measures

Outcome measures
Measure	Denileukin Diftitox/CHOP Administration n=49 Participants Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Number of Patients That Achieved a Complete Response (CR)	27 participants

Adverse Events

Denileukin Diftitox/CHOP Administration

Serious events: 25 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Denileukin Diftitox/CHOP Administration n=49 participants at risk Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Blood and lymphatic system disorders Febrile Neutropenia	10.2% 5/49 • 4 years
General disorders Fever	4.1% 2/49 • 4 years
Blood and lymphatic system disorders Neutropenia	8.2% 4/49 • 4 years
Immune system disorders Allergic Reaction/Allergy	4.1% 2/49 • 4 years
Blood and lymphatic system disorders Leukopenia	6.1% 3/49 • 4 years
Blood and lymphatic system disorders Lymphopenia	4.1% 2/49 • 4 years
Blood and lymphatic system disorders Thrombocytopenia	6.1% 3/49 • 4 years
Cardiac disorders Cardiac Arrest	6.1% 3/49 • 4 years
General disorders Death NOS	4.1% 2/49 • 4 years

Other adverse events

Other adverse events
Measure	Denileukin Diftitox/CHOP Administration n=49 participants at risk Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
Blood and lymphatic system disorders Anemia	40.8% 20/49 • 4 years
Blood and lymphatic system disorders Leukocytopenia	34.7% 17/49 • 4 years
Blood and lymphatic system disorders Lymphopenia	30.6% 15/49 • 4 years
Blood and lymphatic system disorders Thrombocytopenia	28.6% 14/49 • 4 years
Blood and lymphatic system disorders Neutropenia	26.5% 13/49 • 4 years
General disorders Fatigue	63.3% 31/49 • 4 years
Gastrointestinal disorders Nausea	46.9% 23/49 • 4 years
Musculoskeletal and connective tissue disorders Neuropathy, sensory	40.8% 20/49 • 4 years
Blood and lymphatic system disorders Alanine Aminotransferase (ALT) Elevated	34.7% 17/49 • 4 years
Metabolism and nutrition disorders Hyperglycemia	34.7% 17/49 • 4 years
Hepatobiliary disorders Hypoalbuminemia	34.7% 17/49 • 4 years
General disorders Fever	32.7% 16/49 • 4 years
Metabolism and nutrition disorders Hypocalcemia	30.6% 15/49 • 4 years
Hepatobiliary disorders Aspartate Aminotransferase (AST) Elevation	28.6% 14/49 • 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 14/49 • 4 years
Skin and subcutaneous tissue disorders Alopecia	26.5% 13/49 • 4 years
Gastrointestinal disorders Constipation	24.5% 12/49 • 4 years
Vascular disorders Edema, peripheral	20.4% 10/49 • 4 years
Metabolism and nutrition disorders Hyponatremia	20.4% 10/49 • 4 years
Gastrointestinal disorders Dysgeusia	18.4% 9/49 • 4 years
Respiratory, thoracic and mediastinal disorders Cough	16.3% 8/49 • 4 years
Gastrointestinal disorders Heartburn	16.3% 8/49 • 4 years
General disorders Bone Pain	16.3% 8/49 • 4 years
Gastrointestinal disorders Vomiting	16.3% 8/49 • 4 years

Additional Information

Francine Foss, MD

Yale University School of Medicine

Phone: 203-737-5312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place