Trial Outcomes & Findings for Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma (NCT NCT00166439)
NCT ID: NCT00166439
Last Updated: 2020-01-14
Results Overview
The overall response rate is defined as the percentage of patients who achieve a response after two cycles of oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD). A response was considered a Complete Response (CR) or Partial Response (PR) as defined by the NCI Sponsored International Working Group (IWG). CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 42 days
Results posted on
2020-01-14
Participant Flow
Participant milestones
| Measure |
Treatment (ROAD)
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (ROAD)
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Overall Study
Ineligible
|
5
|
Baseline Characteristics
Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (ROAD)
n=45 Participants
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysThe overall response rate is defined as the percentage of patients who achieve a response after two cycles of oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD). A response was considered a Complete Response (CR) or Partial Response (PR) as defined by the NCI Sponsored International Working Group (IWG). CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses.
Outcome measures
| Measure |
Treatment (ROAD)
n=45 Participants
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Overall Response Rate After Two Cycles of ROAD
|
58 percentage of patients
Interval 44.0 to 74.0
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SECONDARY outcome
Timeframe: Up to 10 yearsSurvival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (ROAD)
n=45 Participants
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Overall Survival
|
26 months
Interval 7.3 to
The 95% confidence interval upper limit was not reached (below the level of detection).
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SECONDARY outcome
Timeframe: Up to 10 yearsThe progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined by the NCI Sponsored IWG as a ≥ 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or nonresponders and/or Appearance of any new lesion during or at the end of therapy.
Outcome measures
| Measure |
Treatment (ROAD)
n=45 Participants
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Progression-free Survival
|
11 months
Interval 6.0 to 104.0
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Adverse Events
Treatment (ROAD)
Serious events: 3 serious events
Other events: 43 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Treatment (ROAD)
n=45 participants at risk
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Gastrointestinal disorders
Small intestinal obstruction
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2.2%
1/45 • Number of events 1
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Investigations
Platelet count decreased
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2.2%
1/45 • Number of events 1
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Renal and urinary disorders
Ureteric obstruction
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2.2%
1/45 • Number of events 1
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Other adverse events
| Measure |
Treatment (ROAD)
n=45 participants at risk
The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
17.8%
8/45 • Number of events 8
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Blood and lymphatic system disorders
Hemoglobin decreased
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42.2%
19/45 • Number of events 36
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Cardiac disorders
Atrial fibrillation
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2.2%
1/45 • Number of events 1
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Cardiac disorders
Atrial tachycardia
|
2.2%
1/45 • Number of events 1
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|
Cardiac disorders
Left ventricular dysfunction
|
2.2%
1/45 • Number of events 1
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|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2
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|
Gastrointestinal disorders
Anal pain
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
6/45 • Number of events 9
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|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral (funct/sympt)
|
8.9%
4/45 • Number of events 4
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Gastrointestinal disorders
Nausea
|
73.3%
33/45 • Number of events 51
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Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/45 • Number of events 1
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|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
48.9%
22/45 • Number of events 28
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General disorders
Edema limbs
|
4.4%
2/45 • Number of events 2
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|
General disorders
Fatigue
|
44.4%
20/45 • Number of events 30
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|
General disorders
Fever
|
8.9%
4/45 • Number of events 4
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|
Immune system disorders
Hypersensitivity
|
2.2%
1/45 • Number of events 1
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|
Infections and infestations
Anal infection(gr 3/4 ANC)
|
2.2%
1/45 • Number of events 1
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|
Infections and infestations
Infection(gr 0/1/2 ANC)
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Lip infection(unknown ANC)
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Pneumonia(gr 0/1/2 ANC)
|
6.7%
3/45 • Number of events 3
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|
Infections and infestations
Pneumonia(gr 3/4 ANC)
|
6.7%
3/45 • Number of events 3
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|
Infections and infestations
Pneumonia(unknown ANC)
|
2.2%
1/45 • Number of events 1
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|
Infections and infestations
Sepsis(gr 0/1/2 ANC)
|
4.4%
2/45 • Number of events 2
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|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upper respiratory infectn(gr 0/1/2 ANC)
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upr aerodigstve trct infctn(gr0/1/2 ANC)
|
2.2%
1/45 • Number of events 1
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|
Infections and infestations
Urinary tract infection(gr 0/1/2 ANC)
|
4.4%
2/45 • Number of events 2
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Investigations
Alkaline phosphatase increased
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4.4%
2/45 • Number of events 2
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|
Investigations
Aspartate aminotransferase increased
|
4.4%
2/45 • Number of events 2
|
|
Investigations
Creatinine increased
|
13.3%
6/45 • Number of events 6
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|
Investigations
Leukocyte count decreased
|
40.0%
18/45 • Number of events 31
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|
Investigations
Lymphocyte count decreased
|
11.1%
5/45 • Number of events 10
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|
Investigations
Neutrophil count decreased
|
44.4%
20/45 • Number of events 36
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|
Investigations
Platelet count decreased
|
68.9%
31/45 • Number of events 65
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Metabolism and nutrition disorders
Anorexia
|
20.0%
9/45 • Number of events 11
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|
Metabolism and nutrition disorders
Blood glucose increased
|
20.0%
9/45 • Number of events 18
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|
Metabolism and nutrition disorders
Dehydration
|
13.3%
6/45 • Number of events 8
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|
Metabolism and nutrition disorders
Serum albumin decreased
|
6.7%
3/45 • Number of events 4
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|
Metabolism and nutrition disorders
Serum calcium decreased
|
4.4%
2/45 • Number of events 3
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|
Metabolism and nutrition disorders
Serum magnesium decreased
|
35.6%
16/45 • Number of events 21
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|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.4%
2/45 • Number of events 2
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|
Metabolism and nutrition disorders
Serum potassium decreased
|
40.0%
18/45 • Number of events 23
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|
Metabolism and nutrition disorders
Serum potassium increased
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/45 • Number of events 1
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|
Nervous system disorders
Peripheral motor neuropathy
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
55.6%
25/45 • Number of events 47
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.9%
4/45 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
3/45 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis (clin exam)
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
3/45 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.4%
2/45 • Number of events 2
|
|
Vascular disorders
Hypotension
|
8.9%
4/45 • Number of events 4
|
|
Vascular disorders
Thrombosis
|
2.2%
1/45 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place