Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00788892
Collaborator
(none)
126
28
2
38
4.5
0.1
Study Details
Study Description
Brief Summary
The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.
The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Study Design
Study Type:
Interventional
Actual Enrollment
:
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Jun 1, 2010
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: CPX-351 First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 |
Drug: CPX-351
|
| Active Comparator: Arm B: Cytarabine + Daunorubicin First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
Drug: Cytarabine
Drug: Daunorubicin
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Complete Remission [Within 6 weeks of the last induction treatment]
Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.
Secondary Outcome Measures
- Remission Duration/Time to Remission [Following achievement of CR over the study period]
Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died. Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.
- Event Free Survival [Up to 1 year from randomization]
Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.
- Overall Survival Rate at 1 Year [1 year]
Survival defined as the time from randomization to death.
- Rate of Stem Cell Transplant [Up to 1 year]
The rate of patients who underwent stem cell transplant.
- Aplasia Rate [Day 14 (1st Induction)]
Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥60 and <76 years at the time of diagnosis of AML
-
Pathological confirmation of AML
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
-
Able to adhere to the study visit schedule and other protocol requirements
-
Laboratory values fulfilling the following:
Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- Cardiac ejection fraction > 50% by echocardiography or MUGA scan
Exclusion Criteria:
-
Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible)
-
Prior treatment for AML; only hydroxyurea is permitted (see below)
-
Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
-
Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
-
Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
-
Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
-
Clinical evidence of active CNS leukemia
-
Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
-
Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
-
Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
-
Hypersensitivity to cytarabine, daunorubicin or liposomal products
-
History of Wilson's disease or other copper-related disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Cancer Center | Tucson | Arizona | United States | 85724-5024 |
| 2 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 3 | UC Davis Cancer Center | Sacramento | California | United States | 95817 |
| 4 | University of California Medical Center | San Francisco | California | United States | 94143 |
| 5 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
| 6 | Shands Jacksonville Medical Center | Jacksonville | Florida | United States | 32209 |
| 7 | H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 8 | Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | United States | 30342 |
| 9 | Robert H.Lurie Comprehensive Cancer Center | Chicago | Illinois | United States | 60611 |
| 10 | Rush University Medical Center | Chicago | Illinois | United States | 60612-3861 |
| 11 | St.Francis Hospital | Beech Grove | Indiana | United States | 46107 |
| 12 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 13 | Northern New Jersey Cancer Associates | Hackensack | New Jersey | United States | 07601 |
| 14 | North Shore University Hospital | Manhasset | New York | United States | 11020 |
| 15 | Weil Cornell Medical Center | New York | New York | United States | 10021 |
| 16 | New York Medical College, Division of Oncology | Valhalla | New York | United States | 10595 |
| 17 | Blumenthal Cancer Center/Mecklenburg Medical Group | Charlotte | North Carolina | United States | 28204 |
| 18 | Jewish Hospital | Cincinnati | Ohio | United States | 45236 |
| 19 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 20 | University of Pittsburg Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 21 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 22 | Joe Arrington Cancer Center | Lubbock | Texas | United States | 79410 |
| 23 | Texas Tech University Health Sciences Center | Lubbock | Texas | United States | 79415 |
| 24 | Cancer Therapy and Research Center at the University of Texas | San Antonio | Texas | United States | 78229 |
| 25 | Froedlert Hospital/Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 26 | BC Cancer Research Center | Vancouver | British Columbia | Canada | V5Z 1L3 |
| 27 | Queen Elisabeth II Health Sciences Center | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 28 | McGill University Department of Oncology | Montreal | Quebec | Canada | H2W 1S6 |
Sponsors and Collaborators
- Jazz Pharmaceuticals
Investigators
- Principal Investigator: Jeffrey E Lancet, MD, H. Lee Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00788892
Other Study ID Numbers:
- CLTR0308-204
First Posted:
Nov 11, 2008
Last Update Posted:
Jan 12, 2018
Last Verified:
Oct 1, 2017
Keywords provided by Jazz Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Period Title: Overall Study | ||
| STARTED | 85 | 41 |
| COMPLETED | 36 | 18 |
| NOT COMPLETED | 49 | 23 |
Baseline Characteristics
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin | Total |
|---|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice | Total of all reporting groups |
| Overall Participants | 85 | 41 | 126 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.8
(4.63)
|
68.2
(4.88)
|
67.9
(4.69)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
32
37.6%
|
16
39%
|
48
38.1%
|
| Male |
53
62.4%
|
25
61%
|
78
61.9%
|
Outcome Measures
| Title | Number of Participants With Complete Remission |
|---|---|
| Description | Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts. |
| Time Frame | Within 6 weeks of the last induction treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set. |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Count of Participants [Participants] |
41
48.2%
|
20
48.8%
|
| Title | Remission Duration/Time to Remission |
|---|---|
| Description | Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died. Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met. |
| Time Frame | Following achievement of CR over the study period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Remission Duration |
275
|
235
|
| Time to Remission |
49
|
40
|
| Title | Event Free Survival |
|---|---|
| Description | Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first. |
| Time Frame | Up to 1 year from randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Median (95% Confidence Interval) [days] |
161
|
55
|
| Title | Overall Survival Rate at 1 Year |
|---|---|
| Description | Survival defined as the time from randomization to death. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Number [participants] |
39
45.9%
|
18
43.9%
|
| Title | Rate of Stem Cell Transplant |
|---|---|
| Description | The rate of patients who underwent stem cell transplant. |
| Time Frame | Up to 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Count of Participants [Participants] |
13
15.3%
|
10
24.4%
|
| Title | Aplasia Rate |
|---|---|
| Description | Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation. |
| Time Frame | Day 14 (1st Induction) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Evaluable Analysis Set |
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin |
|---|---|---|
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice |
| Measure Participants | 84 | 41 |
| Count of Participants [Participants] |
55
64.7%
|
15
36.6%
|
Adverse Events
| Time Frame | Assessed during treatment period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety Analysis Set included subjects receiving at least 1 dose of study drug and consisted of 126 subjects. | |||
| Arm/Group Title | Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin | ||
| Arm/Group Description | First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 | First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice | ||
All Cause Mortality |
||||
| Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 47/85 (55.3%) | 16/41 (39%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/85 (1.2%) | 0/41 (0%) | ||
| Febrile Neutropenia | 9/85 (10.6%) | 4/41 (9.8%) | ||
| Thrombocytopenia | 1/85 (1.2%) | 1/41 (2.4%) | ||
| Cardiac disorders | ||||
| Acute Myocardial Infarction | 0/85 (0%) | 1/41 (2.4%) | ||
| Angina Pectoris | 0/85 (0%) | 1/41 (2.4%) | ||
| Atrial Fibrillation | 1/85 (1.2%) | 0/41 (0%) | ||
| Cardiac Arrest | 0/85 (0%) | 1/41 (2.4%) | ||
| Cardiac Failure Congestive | 1/85 (1.2%) | 0/41 (0%) | ||
| Myocardial Infarction | 1/85 (1.2%) | 2/41 (4.9%) | ||
| Restrictive Cardiomyopathy | 1/85 (1.2%) | 0/41 (0%) | ||
| Supraventricular Tachycardia | 0/85 (0%) | 1/41 (2.4%) | ||
| Eye disorders | ||||
| Blindness | 1/85 (1.2%) | 0/41 (0%) | ||
| Mouth Haemorrhage | 1/85 (1.2%) | 0/41 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Pain | 3/85 (3.5%) | 0/41 (0%) | ||
| Gastrointestinal Necrosis | 0/85 (0%) | 1/41 (2.4%) | ||
| Ileal Perforation | 1/85 (1.2%) | 0/41 (0%) | ||
| Nausea | 1/85 (1.2%) | 0/41 (0%) | ||
| Small Intestinal Obstruction | 1/85 (1.2%) | 0/41 (0%) | ||
| Vomiting | 1/85 (1.2%) | 0/41 (0%) | ||
| General disorders | ||||
| Disease Progression | 3/85 (3.5%) | 0/41 (0%) | ||
| Infusion Related Reaction | 1/85 (1.2%) | 0/41 (0%) | ||
| Pain | 1/85 (1.2%) | 0/41 (0%) | ||
| Pyrexia | 7/85 (8.2%) | 0/41 (0%) | ||
| Hepatobiliary disorders | ||||
| Hyperbilirubinaemia | 1/85 (1.2%) | 0/41 (0%) | ||
| Immune system disorders | ||||
| Graft Versus Host Disease | 1/85 (1.2%) | 0/41 (0%) | ||
| Infections and infestations | ||||
| Bacteraemia | 6/85 (7.1%) | 1/41 (2.4%) | ||
| Catheter Site Cellulitis | 1/85 (1.2%) | 0/41 (0%) | ||
| Catheter Site Infection | 1/85 (1.2%) | 0/41 (0%) | ||
| Cellulitis | 1/85 (1.2%) | 0/41 (0%) | ||
| Clostridium Difficile Colitis | 0/85 (0%) | 1/41 (2.4%) | ||
| Device Related Sepsis | 1/85 (1.2%) | 0/41 (0%) | ||
| Fungal Infection | 1/85 (1.2%) | 0/41 (0%) | ||
| Fungal Retinitis | 1/85 (1.2%) | 0/41 (0%) | ||
| Fungal Skin Infection | 1/85 (1.2%) | 0/41 (0%) | ||
| Pneumonia | 4/85 (4.7%) | 2/41 (4.9%) | ||
| Pneumonia Fungal | 2/85 (2.4%) | 0/41 (0%) | ||
| Sepsis | 7/85 (8.2%) | 2/41 (4.9%) | ||
| Septic Shock | 0/85 (0%) | 1/41 (2.4%) | ||
| System Mycosis | 1/85 (1.2%) | 0/41 (0%) | ||
| Urinary Tract Infection | 0/85 (0%) | 1/41 (2.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Brain Herniation | 1/85 (1.2%) | 0/41 (0%) | ||
| Hip Fracture | 1/85 (1.2%) | 0/41 (0%) | ||
| Investigations | ||||
| Blood Creatinine Increased | 1/85 (1.2%) | 0/41 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute Myeloid Leukaemia | 1/85 (1.2%) | 0/41 (0%) | ||
| Leukaemia Recurrent | 0/85 (0%) | 1/41 (2.4%) | ||
| Malignant Melanoma In Situ | 1/85 (1.2%) | 0/41 (0%) | ||
| Nervous system disorders | ||||
| Convulsion | 1/85 (1.2%) | 0/41 (0%) | ||
| Haemorrhage Intracranial | 1/85 (1.2%) | 0/41 (0%) | ||
| Subarachnoid Haemorrhage | 1/85 (1.2%) | 0/41 (0%) | ||
| Syncope | 1/85 (1.2%) | 0/41 (0%) | ||
| Psychiatric disorders | ||||
| Mental Status Changes | 1/85 (1.2%) | 0/41 (0%) | ||
| Psychotic Disorder | 0/85 (0%) | 1/41 (2.4%) | ||
| Renal and urinary disorders | ||||
| Nephrogenic Diabetes Insipidus | 1/85 (1.2%) | 0/41 (0%) | ||
| Renal Failure | 0/85 (0%) | 1/41 (2.4%) | ||
| Renal Failure Acute | 3/85 (3.5%) | 0/41 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Failure | 1/85 (1.2%) | 0/41 (0%) | ||
| Dyspnoea | 2/85 (2.4%) | 1/41 (2.4%) | ||
| Epistaxis | 2/85 (2.4%) | 0/41 (0%) | ||
| Non-Cardiogenic Pulmonary Oedema | 1/85 (1.2%) | 0/41 (0%) | ||
| Pulmonary Oedema | 0/85 (0%) | 1/41 (2.4%) | ||
| Respiratory Arrest | 0/85 (0%) | 1/41 (2.4%) | ||
| Respiratory Distress | 1/85 (1.2%) | 0/41 (0%) | ||
| Respiratory Failure | 2/85 (2.4%) | 0/41 (0%) | ||
| Respiratory Tract Haemorrhage | 1/85 (1.2%) | 0/41 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/85 (1.2%) | 0/41 (0%) | ||
| Stevens-Johnson Syndrome | 1/85 (1.2%) | 0/41 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 0/85 (0%) | 1/41 (2.4%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm A: CPX-351 | Arm B: Cytarabine + Daunorubicin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 85/85 (100%) | 41/41 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/85 (3.5%) | 3/41 (7.3%) | ||
| Febrile Neutropenia | 50/85 (58.8%) | 19/41 (46.3%) | ||
| Neutropenia | 7/85 (8.2%) | 6/41 (14.6%) | ||
| Thrombocytopenia | 7/85 (8.2%) | 5/41 (12.2%) | ||
| Increased tendency to bruise | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Cardiac disorders | ||||
| Angina Pectoris | 2/85 (2.4%) | 5/41 (12.2%) | ||
| Atrial Fibrillation | 12/85 (14.1%) | 4/41 (9.8%) | ||
| Bradycardia | 8/85 (9.4%) | 1/41 (2.4%) | ||
| Tachycardia | 11/85 (12.9%) | 7/41 (17.1%) | ||
| Eye disorders | ||||
| Conjunctivitis | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Distension | 11/85 (12.9%) | 6/41 (14.6%) | ||
| Abdominal Pain | 20/85 (23.5%) | 6/41 (14.6%) | ||
| Abdominal Pain Upper | 10/85 (11.8%) | 2/41 (4.9%) | ||
| Ascites | 3/85 (3.5%) | 3/41 (7.3%) | ||
| Constipation | 43/85 (50.6%) | 23/41 (56.1%) | ||
| Diarrhoea | 56/85 (65.9%) | 27/41 (65.9%) | ||
| Dry Mouth | 9/85 (10.6%) | 3/41 (7.3%) | ||
| Dyspepsia | 11/85 (12.9%) | 5/41 (12.2%) | ||
| Dysphagia | 6/85 (7.1%) | 2/41 (4.9%) | ||
| Haemorrhoids | 7/85 (8.2%) | 5/41 (12.2%) | ||
| Mouth Haemorrhage | 10/85 (11.8%) | 4/41 (9.8%) | ||
| Mouth Ulceration | 6/85 (7.1%) | 1/41 (2.4%) | ||
| Nausea | 56/85 (65.9%) | 22/41 (53.7%) | ||
| Oral Disorder | 6/85 (7.1%) | 2/41 (4.9%) | ||
| Oral Pain | 6/85 (7.1%) | 0/41 (0%) | ||
| Stomatitis | 30/85 (35.3%) | 9/41 (22%) | ||
| Toothache | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Vomiting | 23/85 (27.1%) | 12/41 (29.3%) | ||
| Gingival bleeding | 3/85 (3.5%) | 3/41 (7.3%) | ||
| Melaena | 2/85 (2.4%) | 4/41 (9.8%) | ||
| Proctalgia | 6/85 (7.1%) | 0/41 (0%) | ||
| General disorders | ||||
| Asthenia | 13/85 (15.3%) | 7/41 (17.1%) | ||
| Catheter SIte Erythema | 17/85 (20%) | 6/41 (14.6%) | ||
| Catheter Site Pain | 9/85 (10.6%) | 5/41 (12.2%) | ||
| Chills | 33/85 (38.8%) | 13/41 (31.7%) | ||
| Fatigue | 35/85 (41.2%) | 12/41 (29.3%) | ||
| Gait Disturbance | 5/85 (5.9%) | 0/41 (0%) | ||
| Oedema peripheral | 44/85 (51.8%) | 18/41 (43.9%) | ||
| Oedema | 6/85 (7.1%) | 5/41 (12.2%) | ||
| Pain | 9/85 (10.6%) | 3/41 (7.3%) | ||
| Pyrexia | 26/85 (30.6%) | 14/41 (34.1%) | ||
| Chest pain | 7/85 (8.2%) | 0/41 (0%) | ||
| Hepatobiliary disorders | ||||
| Hyperbilirubinaemia | 9/85 (10.6%) | 3/41 (7.3%) | ||
| Immune system disorders | ||||
| Drug Hypersensitivity | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Infections and infestations | ||||
| Bacteraemia | 10/85 (11.8%) | 2/41 (4.9%) | ||
| Catheter Site Infection | 5/85 (5.9%) | 5/41 (12.2%) | ||
| Cellulitis | 6/85 (7.1%) | 3/41 (7.3%) | ||
| Clostridium difficile infection | 9/85 (10.6%) | 0/41 (0%) | ||
| Pneumonia | 15/85 (17.6%) | 12/41 (29.3%) | ||
| Bacterial disease carrier | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Enterococcal bacteraemia | 5/85 (5.9%) | 4/41 (9.8%) | ||
| Staphylococcal bacteraemia | 12/85 (14.1%) | 1/41 (2.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Transfusion Reaction | 10/85 (11.8%) | 2/41 (4.9%) | ||
| Investigations | ||||
| Blood Alkaline Phosphate Increased | 5/85 (5.9%) | 0/41 (0%) | ||
| Blood Creatinine Increased | 5/85 (5.9%) | 4/41 (9.8%) | ||
| Breath Sounds Abnormal | 5/85 (5.9%) | 0/41 (0%) | ||
| Cardiac Murmur | 8/85 (9.4%) | 1/41 (2.4%) | ||
| Weight Decreased | 7/85 (8.2%) | 5/41 (12.2%) | ||
| Weight Increased | 8/85 (9.4%) | 2/41 (4.9%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 34/85 (40%) | 16/41 (39%) | ||
| Dehydration | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Fluid Overload | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Hyperglycaemia | 2/85 (2.4%) | 4/41 (9.8%) | ||
| Hypokalaemia | 21/85 (24.7%) | 14/41 (34.1%) | ||
| Hypomagnesaemia | 12/85 (14.1%) | 2/41 (4.9%) | ||
| Hyponatraemia | 7/85 (8.2%) | 1/41 (2.4%) | ||
| Hypophosphataemia | 8/85 (9.4%) | 2/41 (4.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 12/85 (14.1%) | 2/41 (4.9%) | ||
| Muscular Weakness | 4/85 (4.7%) | 5/41 (12.2%) | ||
| Myalgia | 7/85 (8.2%) | 1/41 (2.4%) | ||
| Back pain | 11/85 (12.9%) | 4/41 (9.8%) | ||
| Musculoskeletal pain | 7/85 (8.2%) | 2/41 (4.9%) | ||
| Neck pain | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Pain in extremity | 13/85 (15.3%) | 4/41 (9.8%) | ||
| Pain in jaw | 1/85 (1.2%) | 3/41 (7.3%) | ||
| Nervous system disorders | ||||
| Dizziness | 19/85 (22.4%) | 12/41 (29.3%) | ||
| Dysgeusia | 6/85 (7.1%) | 3/41 (7.3%) | ||
| Headache | 30/85 (35.3%) | 8/41 (19.5%) | ||
| Lethargy | 6/85 (7.1%) | 0/41 (0%) | ||
| Somnolence | 6/85 (7.1%) | 0/41 (0%) | ||
| Syncope | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Tremor | 6/85 (7.1%) | 1/41 (2.4%) | ||
| Psychiatric disorders | ||||
| Anxiety | 16/85 (18.8%) | 7/41 (17.1%) | ||
| Confusional State | 12/85 (14.1%) | 1/41 (2.4%) | ||
| Depression | 10/85 (11.8%) | 2/41 (4.9%) | ||
| Hallucination | 11/85 (12.9%) | 1/41 (2.4%) | ||
| Insomnia | 24/85 (28.2%) | 5/41 (12.2%) | ||
| Mental Status Change | 5/85 (5.9%) | 3/41 (7.3%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Pollakiuria | 2/85 (2.4%) | 3/41 (7.3%) | ||
| Renal Failure | 3/85 (3.5%) | 3/41 (7.3%) | ||
| Renal Failure Acute | 5/85 (5.9%) | 2/41 (4.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Atelectasis | 6/85 (7.1%) | 5/41 (12.2%) | ||
| Cough | 33/85 (38.8%) | 5/41 (12.2%) | ||
| Dysphonia | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Dyspnoea | 18/85 (21.2%) | 5/41 (12.2%) | ||
| Dyspnoea Exertional | 5/85 (5.9%) | 1/41 (2.4%) | ||
| Epistaxis | 30/85 (35.3%) | 8/41 (19.5%) | ||
| Haemoptysis | 6/85 (7.1%) | 0/41 (0%) | ||
| Hiccups | 2/85 (2.4%) | 3/41 (7.3%) | ||
| Hypoxia | 13/85 (15.3%) | 4/41 (9.8%) | ||
| Nasal Congestion | 7/85 (8.2%) | 1/41 (2.4%) | ||
| Oropharyngeal Pain | 14/85 (16.5%) | 6/41 (14.6%) | ||
| Pleural Effusion | 15/85 (17.6%) | 5/41 (12.2%) | ||
| Pulmonary Hypertension | 1/85 (1.2%) | 3/41 (7.3%) | ||
| Pulmonary Oedema | 6/85 (7.1%) | 2/41 (4.9%) | ||
| Rales | 10/85 (11.8%) | 5/41 (12.2%) | ||
| Tachypnoea | 1/85 (1.2%) | 4/41 (9.8%) | ||
| Wheezing | 5/85 (5.9%) | 0/41 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 5/85 (5.9%) | 9/41 (22%) | ||
| Dry Skin | 6/85 (7.1%) | 2/41 (4.9%) | ||
| Ecchymosis | 8/85 (9.4%) | 1/41 (2.4%) | ||
| Erythema | 10/85 (11.8%) | 7/41 (17.1%) | ||
| Hyperhidrosis | 14/85 (16.5%) | 0/41 (0%) | ||
| Night Sweats | 8/85 (9.4%) | 3/41 (7.3%) | ||
| Petechiae | 28/85 (32.9%) | 5/41 (12.2%) | ||
| Pruritus | 22/85 (25.9%) | 6/41 (14.6%) | ||
| Rash | 45/85 (52.9%) | 15/41 (36.6%) | ||
| Skin Lesion | 6/85 (7.1%) | 1/41 (2.4%) | ||
| Purpura | 4/85 (4.7%) | 3/41 (7.3%) | ||
| Rash erythematous | 8/85 (9.4%) | 6/41 (14.6%) | ||
| Rash maculo-papular | 11/85 (12.9%) | 1/41 (2.4%) | ||
| Vascular disorders | ||||
| Hypertension | 16/85 (18.8%) | 6/41 (14.6%) | ||
| Hypotension | 15/85 (17.6%) | 10/41 (24.4%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Associate Director, Clinical Trial Disclosure & Transparency |
|---|---|
| Organization | Jazz Pharmaceuticals |
| Phone | 215-832-3750 |
Responsible Party:
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00788892
Other Study ID Numbers:
- CLTR0308-204
First Posted:
Nov 11, 2008
Last Update Posted:
Jan 12, 2018
Last Verified:
Oct 1, 2017