Trial Outcomes & Findings for Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00244985)
NCT ID: NCT00244985
Last Updated: 2017-08-17
Results Overview
Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes \> 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.
COMPLETED
PHASE1/PHASE2
42 participants
20 weeks
2017-08-17
Participant Flow
Participant milestones
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: All treated and eligible patients
Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes \> 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.
Outcome measures
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Complete Response Rate at 20 Weeks
|
45 percentage of participants
Interval 30.0 to 61.0
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All treated and eligible patients
Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the \> or = to 50% decrease. Additionally, no appearance of new lesions is noted.
Outcome measures
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Partial Response Rate at 20 Weeks
|
19 percentage of participants
Interval 9.0 to 34.0
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All treated and eligible patients
Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes \> 1.5 before therapy. Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the \> or = to 50% decrease. Additionally, no appearance of new lesions is noted.
Outcome measures
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Overall Response Rate (Complete and Partial Responses) at 20 Weeks
|
64 percentage of participants
Interval 48.0 to 78.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All treated and eligible patients
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Progression Free Survival (PFS) Rate at 2 Years
|
42 percentage of participants
Interval 32.0 to 62.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All treated and eligible patients
Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
Outcome measures
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 Participants
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Overall Survival (OS) Rate at 2 Years
|
83 percentage of participants
Interval 68.0 to 92.0
|
Adverse Events
Arm 1: Rituximab and Doxorubicin HCI Liposome
Serious adverse events
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 participants at risk
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fever
|
4.8%
2/42 • Number of events 3
|
|
Infections and infestations
Mucosal infection
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Arm 1: Rituximab and Doxorubicin HCI Liposome
n=42 participants at risk
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
rituximab: IV
pegylated liposomal doxorubicin hydrochloride: IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.8%
10/42 • Number of events 11
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
38.1%
16/42 • Number of events 18
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.8%
2/42 • Number of events 4
|
|
Cardiac disorders
Chest pain - cardiac
|
4.8%
2/42 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/42 • Number of events 9
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • Number of events 17
|
|
Eye disorders
Conjunctivitis
|
2.4%
1/42 • Number of events 32
|
|
Eye disorders
Eye disorders - Other, specify
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 31
|
|
Gastrointestinal disorders
Anal pain
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
21.4%
9/42 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • Number of events 31
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
2/42 • Number of events 8
|
|
Gastrointestinal disorders
Esophageal pain
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • Number of events 18
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
31.0%
13/42 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
16.7%
7/42 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 20
|
|
General disorders
Chills
|
21.4%
9/42 • Number of events 10
|
|
General disorders
Edema limbs
|
4.8%
2/42 • Number of events 2
|
|
General disorders
Fatigue
|
42.9%
18/42 • Number of events 25
|
|
General disorders
Fever
|
11.9%
5/42 • Number of events 6
|
|
General disorders
Flu like symptoms
|
2.4%
1/42 • Number of events 1
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
4.8%
2/42 • Number of events 3
|
|
General disorders
Infusion related reaction
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Infusion site extravasation
|
2.4%
1/42 • Number of events 3
|
|
General disorders
Localized edema
|
4.8%
2/42 • Number of events 3
|
|
General disorders
Pain
|
19.0%
8/42 • Number of events 35
|
|
Infections and infestations
Bronchial infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.9%
5/42 • Number of events 6
|
|
Infections and infestations
Mucosal infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Nail infection
|
2.4%
1/42 • Number of events 2
|
|
Infections and infestations
Papulopustular rash
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
9.5%
4/42 • Number of events 8
|
|
Infections and infestations
Upper respiratory infection
|
9.5%
4/42 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 11
|
|
Infections and infestations
tooth infection
|
4.8%
2/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 4
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.4%
1/42 • Number of events 6
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • Number of events 10
|
|
Investigations
Investigations - Other, specify
|
4.8%
2/42 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
38.1%
16/42 • Number of events 16
|
|
Investigations
Platelet count decreased
|
45.2%
19/42 • Number of events 20
|
|
Investigations
Weight loss
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
2/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 57
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.4%
1/42 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
3/42 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.8%
2/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
3/42 • Number of events 18
|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • Number of events 17
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/42 • Number of events 21
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 37
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
1/42 • Number of events 5
|
|
Psychiatric disorders
Depression
|
2.4%
1/42 • Number of events 31
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/42 • Number of events 17
|
|
Psychiatric disorders
Restlessness
|
2.4%
1/42 • Number of events 14
|
|
Renal and urinary disorders
Bladder spasm
|
2.4%
1/42 • Number of events 2
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
9.5%
4/42 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
2/42 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.4%
1/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
4/42 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.9%
5/42 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/42 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
23.8%
10/42 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
71.4%
30/42 • Number of events 47
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 35
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 24
|
|
Vascular disorders
Superior vena cava syndrome
|
2.4%
1/42 • Number of events 4
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place