Trial Outcomes & Findings for CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas (NCT NCT00185965)

NCT ID: NCT00185965

Last Updated: 2014-08-01

Results Overview

Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-08-01

Participant Flow

Participant milestones

Measure	Lymphoma, B-cell Low-grade (BCL) Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Lymphoma, B-cell Low-grade (BCL) Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
Overall Study Adverse Event	0	1

Baseline Characteristics

CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

Baseline characteristics by cohort

Measure	Lymphoma, B-cell Low-grade (BCL) n=15 Participants Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) n=15 Participants Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Total n=30 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	57 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)

Outcome measures

Measure	Lymphoma, B-cell Low-grade (BCL) n=15 Participants Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) n=14 Participants Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
Objective Response Rate (ORR)	26.7 percentage of treated subjects	35.7 percentage of treated subjects

Adverse Events

Lymphoma, B-cell Low-grade (BCL)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Mycosis Fungoides (MF)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lymphoma, B-cell Low-grade (BCL) n=15 participants at risk Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) n=15 participants at risk Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
General disorders Injection site reaction	0.00% 0/15	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Lymphoma, B-cell Low-grade (BCL) n=15 participants at risk Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).	Mycosis Fungoides (MF) n=15 participants at risk Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment) CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
General disorders Flu like symptoms	33.3% 5/15 • Number of events 5	0.00% 0/15
General disorders Injection site reaction	6.7% 1/15 • Number of events 1	93.3% 14/15 • Number of events 14
General disorders Chills	0.00% 0/15	93.3% 14/15 • Number of events 14
General disorders Fatigue	0.00% 0/15	86.7% 13/15 • Number of events 13
Nervous system disorders Headache	0.00% 0/15	73.3% 11/15 • Number of events 11
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15	66.7% 10/15 • Number of events 10
General disorders Fever	0.00% 0/15	66.7% 10/15 • Number of events 10
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15	60.0% 9/15 • Number of events 9
Gastrointestinal disorders Diarrhea	0.00% 0/15	26.7% 4/15 • Number of events 4
Gastrointestinal disorders Nausea	0.00% 0/15	20.0% 3/15 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15	13.3% 2/15 • Number of events 2
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/15	13.3% 2/15 • Number of events 2
Nervous system disorders Dizziness	0.00% 0/15	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/15	6.7% 1/15 • Number of events 1
Cardiac disorders Palpitation	0.00% 0/15	6.7% 1/15 • Number of events 1
Infections and infestations Rhinitis infective	0.00% 0/15	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/15	6.7% 1/15 • Number of events 1

Additional Information

Ronald Levy, MD / Robert K and Helen K Summy Professor of Medicine

School of Medicine, Stanford University

Phone: 650-725-6452

Email: levy@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place