Trial Outcomes & Findings for SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma (NCT NCT00365274)

Last Updated: 2014-06-02

Results Overview

Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2014-06-02

Participant Flow

Recruitment Period: August 9, 2006 to February 26, 2009. All recruitment was done in medical clinics.

The six participants were registered at UT MD Anderson Cancer Center prior to early study termination although recruitment was open to multi-centers.

Participant milestones

Participant milestones
Measure	SGN-30 + Combination Chemotherapy Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SGN-30 + Combination Chemotherapy n=6 Participants Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	SGN-30 + Combination Chemotherapy n=6 Participants Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Objective Response Rate (ORR) Complete Response	83 percentage of participants
Objective Response Rate (ORR) Partial Response	17 percentage of participants

Adverse Events

SGN-30 + Combination Chemotherapy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SGN-30 + Combination Chemotherapy n=6 participants at risk Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	16.7% 1/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated ALT, SGPT	16.7% 1/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated Bilirubin	16.7% 1/6 • 2 years and 11 months
Eye disorders Blurred Vision	33.3% 2/6 • 2 years and 11 months
Gastrointestinal disorders Constipation	33.3% 2/6 • 2 years and 11 months
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • 2 years and 11 months
Gastrointestinal disorders Diarrhea	50.0% 3/6 • 2 years and 11 months
Nervous system disorders Dizziness	33.3% 2/6 • 2 years and 11 months
Gastrointestinal disorders Dry Mouth	16.7% 1/6 • 2 years and 11 months
Skin and subcutaneous tissue disorders Dry Skin	16.7% 1/6 • 2 years and 11 months
Respiratory, thoracic and mediastinal disorders Dysphagia	16.7% 1/6 • 2 years and 11 months
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • 2 years and 11 months
Investigations Edema: head and neck	16.7% 1/6 • 2 years and 11 months
General disorders Fatigue	50.0% 3/6 • 2 years and 11 months
Infections and infestations Fever without neutropenia	33.3% 2/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated Hemoglobin	16.7% 1/6 • 2 years and 11 months
Reproductive system and breast disorders Hot flashes	16.7% 1/6 • 2 years and 11 months
Blood and lymphatic system disorders Hyperglycemia	33.3% 2/6 • 2 years and 11 months
Blood and lymphatic system disorders Hypoglycemia	16.7% 1/6 • 2 years and 11 months
Psychiatric disorders Insomnia	16.7% 1/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated Leukocytes	50.0% 3/6 • 2 years and 11 months
Psychiatric disorders Memory impairment	33.3% 2/6 • 2 years and 11 months
Psychiatric disorders Mood alteration (depression)	16.7% 1/6 • 2 years and 11 months
Respiratory, thoracic and mediastinal disorders Mucositis, oral cavity	66.7% 4/6 • 2 years and 11 months
Gastrointestinal disorders Nausea	33.3% 2/6 • 2 years and 11 months
Nervous system disorders Neuropathy: motor	16.7% 1/6 • 2 years and 11 months
Nervous system disorders Neuropathy: sensory	33.3% 2/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated Neutrophils (ANC/AGC)	33.3% 2/6 • 2 years and 11 months
Eye disorders Ocular/visual (other)	16.7% 1/6 • 2 years and 11 months
Musculoskeletal and connective tissue disorders Pain	66.7% 4/6 • 2 years and 11 months
Blood and lymphatic system disorders Elevated Platelets	16.7% 1/6 • 2 years and 11 months
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • 2 years and 11 months
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 1/6 • 2 years and 11 months
Investigations Rigors/chills	16.7% 1/6 • 2 years and 11 months
Skin and subcutaneous tissue disorders Sweating	16.7% 1/6 • 2 years and 11 months
Gastrointestinal disorders Vomiting	33.3% 2/6 • 2 years and 11 months
Eye disorders Watery Eye	33.3% 2/6 • 2 years and 11 months

Additional Information

Michelle Fanale, MD / Associate Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60