Trial Outcomes & Findings for Rituximab in Treating Patients With Hodgkin's Lymphoma (NCT NCT00003820)
NCT ID: NCT00003820
Last Updated: 2017-04-20
Results Overview
PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
5 years
Results posted on
2017-04-20
Participant Flow
Participant milestones
| Measure |
Rituximab 375 mg/m2 Per Week Inital Group
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months
Initial Group of participants prior to the addition of the three extra cycle treatments.
|
Rituximab 375 mg/m2 Per Week Secondary Group
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months
Secondary Group of participants were added after the addition of the three extra cycle treatments.
|
|---|---|---|
|
Cycle 1 (Initial Treatment)
STARTED
|
23
|
16
|
|
Cycle 1 (Initial Treatment)
COMPLETED
|
23
|
16
|
|
Cycle 1 (Initial Treatment)
NOT COMPLETED
|
0
|
0
|
|
Cycle 2 (Maintenance Treatment)
STARTED
|
0
|
16
|
|
Cycle 2 (Maintenance Treatment)
COMPLETED
|
0
|
16
|
|
Cycle 2 (Maintenance Treatment)
NOT COMPLETED
|
0
|
0
|
|
Cycle 3 (Maintenance Treatment)
STARTED
|
0
|
16
|
|
Cycle 3 (Maintenance Treatment)
COMPLETED
|
0
|
16
|
|
Cycle 3 (Maintenance Treatment)
NOT COMPLETED
|
0
|
0
|
|
Cycle 4 (Maintenance Treatment)
STARTED
|
0
|
16
|
|
Cycle 4 (Maintenance Treatment)
COMPLETED
|
0
|
16
|
|
Cycle 4 (Maintenance Treatment)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab in Treating Patients With Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 Participants
Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 13.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion
Outcome measures
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 Participants
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
|
|---|---|
|
Progression-free Survival (PFS)
|
18 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
OS, assessed as the number of patients 5 years after treatment who are alive
Outcome measures
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 Participants
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
|
|---|---|
|
Overall Survival (OS)
|
36 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
Overall response as assessed as Complete Response (CR) + Partial Response (PR) * CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue. * PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR.
Outcome measures
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 Participants
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
|
|---|---|
|
Overall Response Rate (ORR)
Overall Response (CR+PR)
|
100 percentage of participants
|
|
Overall Response Rate (ORR)
Partial Response
|
33 percentage of participants
|
|
Overall Response Rate (ORR)
Complete Response
|
67 percentage of participants
|
Adverse Events
Rituximab 375 mg/m2 Per Week
Serious events: 28 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 participants at risk
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.
This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer, metastatic
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse/progressive disease, Hodgkin lymphoma
|
35.9%
14/39 • Number of events 14 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse / transformation to aggressive B-cell lymphoma
|
23.1%
9/39 • Number of events 9 • 5 years
|
Other adverse events
| Measure |
Rituximab 375 mg/m2 Per Week
n=39 participants at risk
Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.
This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
|
|---|---|
|
General disorders
Fatigue
|
46.2%
18/39 • Number of events 19 • 5 years
|
|
General disorders
Pain
|
51.3%
20/39 • Number of events 22 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
17.9%
7/39 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
Abdominal bloating
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Aches
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Acid reflux
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Acute abdomen
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Immune system disorders
Allergy
|
20.5%
8/39 • Number of events 9 • 5 years
|
|
Psychiatric disorders
Anxiety
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Aphthous
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Arm tingling
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Infections and infestations
Athlete's foot
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Bloody stool
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Body odor
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Buccal mucosa ulceration
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Burning sensation
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac disorder
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
General disorders
Chills
|
12.8%
5/39 • Number of events 5 • 5 years
|
|
Injury, poisoning and procedural complications
Claudication
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Cold
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Colon cancer
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Depression
|
7.7%
3/39 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.8%
5/39 • Number of events 5 • 5 years
|
|
Psychiatric disorders
Distress
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Eye disorders
Double vision
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dysesthesias
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Early satiety
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Edema
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Investigations
Elevated levels
|
15.4%
6/39 • Number of events 6 • 5 years
|
|
Gastrointestinal disorders
Epigastric gurgling
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Immune system disorders
Facial hives
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Feeling sleepy
|
7.7%
3/39 • Number of events 3 • 5 years
|
|
General disorders
Fever
|
17.9%
7/39 • Number of events 7 • 5 years
|
|
Immune system disorders
Flushing
|
7.7%
3/39 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GI bleeding
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GI irritability
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Endocrine disorders
Graves hyperthyroidism
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headaches
|
15.4%
6/39 • Number of events 6 • 5 years
|
|
Ear and labyrinth disorders
Hearing loss
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Cardiac disorders
Heart murmur
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hip bursitis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
20.5%
8/39 • Number of events 8 • 5 years
|
|
Metabolism and nutrition disorders
Indigestion
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Infusion related reactions
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Psychiatric disorders
Insomnia
|
12.8%
5/39 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Itching
|
25.6%
10/39 • Number of events 10 • 5 years
|
|
Immune system disorders
arthralgias
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Investigations
Leukopenia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Investigations
Lymphopenia
|
23.1%
9/39 • Number of events 9 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Maxillary sinus disease
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Memory loss
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic adenocarcinoma
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Morning stiffness
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Immune system disorders
Myalgias
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.9%
7/39 • Number of events 8 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Night sweats
|
20.5%
8/39 • Number of events 8 • 5 years
|
|
Nervous system disorders
Numbness
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Odynophagia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Oral ulceration
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Oropharyngeal ulceration
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Paresthesia
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Peripheral neuropathy
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pressure in bilateral upper lungs
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Infections and infestations
Rhinitis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Endocrine disorders
Right neck fullness
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Rigors
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Scratchy throat
|
17.9%
7/39 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
12.8%
5/39 • Number of events 5 • 5 years
|
|
Infections and infestations
Skin infection
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Soreness in extremities
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Suicidal ideation
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Vascular disorders
Superficial phlebitis
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Swelling
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Tightness in throat
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Tooth abscess
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
17.9%
7/39 • Number of events 7 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Investigations
Weight gain
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Investigations
Weight loss
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
3/39 • Number of events 3 • 5 years
|
|
Infections and infestations
Wound infection
|
2.6%
1/39 • Number of events 1 • 5 years
|
Additional Information
Ranjana Advani, MD, Professor of Lymphoma
Stanford University
Phone: 650-725-6456
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place