Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

• Sponsor: Jazz Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00822094
• Collaborator: The Leukemia and Lymphoma Society (Other)
• Enrollment: 126
• Locations: 42
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: CPX-351; Drug: Intensive Salvage Therapy	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 intensive first salvage treatment.

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 Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPX-351 (Arm A) First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	Drug: CPX-351
Active Comparator: Salvage Therapy (Arm B) First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice	Drug: Intensive Salvage Therapy

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Surviving at 1 Year [Up to 1 year from randomization]

   The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.

Secondary Outcome Measures

1. Complete Remission Rate [Following 1st induction, following 2nd induction if applicable]

2. Event Free Survival [Up to 1 year from randomization]

   Progression EFS median

3. Remission Duration [Following achievement of CR and up to 1 year from randomization]

   Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.

4. Rate of Aplasia [Up to 1 year from randomization]

   Patients with Aplasia During Study

5. Rate of Stem Cell Transplant [Up to 1 year from randomization]

   Number of patients transferred for stem cell transplant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to understand and voluntarily sign an informed consent form

• Age ≥18 and ≤65 years at the time of relapse

• Pathological confirmation of relapsed AML after initial CR of >1 month duration

• 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 <3xULN Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.

• Cardiac ejection fraction > 50% by echocardiography or MUGA scan

• All men and women must agree to practice effective contraception during the study period and for 3 months afterward if not otherwise documented to be infertile.

Exclusion Criteria:

• Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, with tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and its non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment

• Patients with acute promyelocytic leukemia [t(15;17)]

• Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy

• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent

• Administration of any antineoplastic therapy within 4 weeks of therapy; intended to treat first relapse. 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 New York Heart Association Class III or IV staging

• Active and uncontrolled infection. Patients with a bacterial 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); active hepatitis C infection or known HIV infection

• Hypersensitivity to cytarabine, daunorubicin or liposomal products

• History of Wilson's disease or other copper-related disorder

• Patients with a history of severe toxicity related to receiving conventional dose cytarabine in first line treatment (approximately 100mg/m2/d for <7 days) are excluded. Patients who experienced unacceptable toxicities while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine regimens where the risk of major toxicity is less.

• Woman who are pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	UCLA	Los Angeles	California	United States	90024
3	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
4	UC Davis Cancer Center	Sacramento	California	United States	95817
5	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
6	Northwestern University Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois	United States	60611
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	University of Chicago Medical Center Section of Hematology/Oncology	Chicago	Illinois	United States	60637
9	St. Francis Cancer Center	Beech Grove	Indiana	United States	46107
10	University of Louisville Brown Cancer Center	Louisville	Kentucky	United States	40202
11	Maine General Medical Center Harold Alfond Center for Cancer Care	Waterville	Maine	United States	04901
12	Johns Hopkins University	Baltimore	Maryland	United States	21231
13	St. Louis University Medical Center	Saint Louis	Missouri	United States	63101
14	The Cancer Center, Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
15	North Shore LIJ Center for Advanced Medicine Monter Cancer Center	Lake Success	New York	United States	11042
16	Weil Cornell Medical Center	New York	New York	United States	10021
17	New York Medical College	New York	New York	United States	10595
18	Montefiore Medical Center	The Bronx	New York	United States	10467
19	Blumenthal Cancer Center/Mecklenburg Medical Group	Charlotte	North Carolina	United States	28204
20	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
21	Jewish Hospital of Cincinatti	Cincinnati	Ohio	United States
22	Oregon Health and Science University	Portland	Oregon	United States	97239
23	Oncology and Hematology at Lehigh Valley	Bethlehem	Pennsylvania	United States	18105
24	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
25	UTMB Comprehensive Cancer Center	Galveston	Texas	United States	77555
26	M.D. Anderson Cancer Center	Houston	Texas	United States	77030
27	Joe Arrington Cancer Center	Lubbock	Texas	United States	79410
28	Texas Tech University Health Sciences Center	Lubbock	Texas	United States	79415
29	Cancer Therapy and Research Center at The University of TX Health Science Center	San Antonio	Texas	United States	78229
30	Intermountain LDS Hospital	Salt Lake City	Utah	United States	84143
31	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
32	Vancouver General Hospital/ British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 1M9
33	Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R3E 049
34	Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez	Lille Cedex		France	59037
35	Service des Maladies du Sang Hopital Haut-Leveque	Pessac		France	33604
36	Service d'Hématologie CHU Toulouse-Hôpital Purpan	Toulouse Cedex 09		France	31059
37	Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois	Vandoeuvre les Nancy Cedex		France	54511
38	Klinika Hematologii i Transplantologii	Gdansk		Poland	80-952
39	Wojewódzki Szpital Specjalistyczny im. M. Kopernika	Lodz		Poland	93-510
40	Oddział Hematologii	Opole		Poland	45-372
41	Instytut Hematologii i Transfuzjologii	Warszawa		Poland	02-776
42	Akademia Medyczna we Wroclawlu	Wroclaw		Poland	50-367

Sponsors and Collaborators

• Jazz Pharmaceuticals
• The Leukemia and Lymphoma Society

Investigators

• Principal Investigator: Jonathan Kolitz, MD, North Shore University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Company Website

Publications

None provided.

• Responsible Party: Jazz Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00822094
• Other Study ID Numbers: CLTR0308-205
• First Posted: Jan 14, 2009
• Last Update Posted: Nov 24, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Jazz Pharmaceuticals: Acute; Myeloid; Leukemia; Adult; First; Relapse; AML; Acute Myelogenous leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute myelocytic leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence

Study Results

Participant Flow

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Period Title: Overall Study
STARTED	81	45
COMPLETED	37	20
NOT COMPLETED	44	25

Baseline Characteristics

Arm/Group Title	CPX-351	Salvage Therapy	Total
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice	Total of all reporting groups
Overall Participants	81	44	125
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.4 (11.57)	51.8 (11.54)	50.2 (11.57)
Sex: Female, Male (Count of Participants)
Female	43 53.1%	25 56.8%	68 54.4%
Male	38 46.9%	19 43.2%	57 45.6%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Surviving at 1 Year
Description	The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
Time Frame	Up to 1 year from randomization

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Count of Participants [Participants]	29 35.8%	12 27.3%

2. Secondary Outcome

Title	Complete Remission Rate
Time Frame	Following 1st induction, following 2nd induction if applicable

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Count of Participants [Participants]	30 37%	14 31.8%

3. Secondary Outcome

Title	Event Free Survival
Description	Progression EFS median
Time Frame	Up to 1 year from randomization

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Median (95% Confidence Interval) [days]	75	43

4. Secondary Outcome

Title	Remission Duration
Description	Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.
Time Frame	Following achievement of CR and up to 1 year from randomization

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Median (Full Range) [days]	301	259

5. Secondary Outcome

Title	Rate of Aplasia
Description	Patients with Aplasia During Study
Time Frame	Up to 1 year from randomization

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Count of Participants [Participants]	62 76.5%	24 54.5%

6. Secondary Outcome

Title	Rate of Stem Cell Transplant
Description	Number of patients transferred for stem cell transplant
Time Frame	Up to 1 year from randomization

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Arm/Group Title	CPX-351	Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion	First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Measure Participants	81	44
Count of Participants [Participants]	38 46.9%	21 47.7%

Adverse Events

Time Frame	Continually 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	Safety Population: All randomized participants who received at least one dose of study medication.
Arm/Group Title	CPX-351		Salvage Therapy
Arm/Group Description	First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion		First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
All Cause Mortality
	CPX-351		Salvage Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CPX-351		Salvage Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/81 (65.4%)		22/44 (50%)
Blood and lymphatic system disorders
Anaemia	1/81 (1.2%)		0/44 (0%)
Bone Marrow Necrosis	1/81 (1.2%)		0/44 (0%)
Febrile Neutropenia	7/81 (8.6%)		2/44 (4.5%)
Lymphopenia	1/81 (1.2%)		0/44 (0%)
Neutropenia	1/81 (1.2%)		0/44 (0%)
Pancytopenia	0/81 (0%)		1/44 (2.3%)
Thrombocytopenia	1/81 (1.2%)		0/44 (0%)
Cardiac disorders
Cardiac Failure	1/81 (1.2%)		1/44 (2.3%)
Cardio-Respiratory Arrest	1/81 (1.2%)		0/44 (0%)
Left Ventricular Dysfunction	0/81 (0%)		1/44 (2.3%)
Pericardial Effusion	1/81 (1.2%)		0/44 (0%)
Sinus Bradycardia	0/81 (0%)		1/44 (2.3%)
Eye disorders
Conjunctival Haemorrhage	1/81 (1.2%)		0/44 (0%)
Gastrointestinal disorders
Diarrhoea	1/81 (1.2%)		0/44 (0%)
Enterocolitis	1/81 (1.2%)		0/44 (0%)
Gastrointestinal Haemorrhage	1/81 (1.2%)		0/44 (0%)
Nausea	2/81 (2.5%)		0/44 (0%)
Neutropenic Colitis	1/81 (1.2%)		0/44 (0%)
Rectal Haemorrhage	0/81 (0%)		1/44 (2.3%)
Small Intestinal Obstruction	1/81 (1.2%)		0/44 (0%)
Vomiting	2/81 (2.5%)		0/44 (0%)
General disorders
Chest Pain	1/81 (1.2%)		0/44 (0%)
Death	0/81 (0%)		1/44 (2.3%)
Disease Progression	0/81 (0%)		1/44 (2.3%)
Extravasation	1/81 (1.2%)		0/44 (0%)
Mucosal Inflammation	1/81 (1.2%)		0/44 (0%)
Multi-Organ Failure	0/81 (0%)		1/44 (2.3%)
Pain	0/81 (0%)		1/44 (2.3%)
Pyrexia	2/81 (2.5%)		0/44 (0%)
Sudden Cardiac Death	1/81 (1.2%)		0/44 (0%)
Hepatobiliary disorders
Cholecystitis	1/81 (1.2%)		0/44 (0%)
Hyperbilirubinaemia	1/81 (1.2%)		0/44 (0%)
Infections and infestations
Bacteraemia	11/81 (13.6%)		6/44 (13.6%)
Catheter Site Infection	0/81 (0%)		1/44 (2.3%)
Cellulitis	1/81 (1.2%)		1/44 (2.3%)
Clostridium Difficile Colitis	1/81 (1.2%)		0/44 (0%)
Diverticulitis	1/81 (1.2%)		0/44 (0%)
Fungaemia	0/81 (0%)		1/44 (2.3%)
Gastrointestinal Bacterial Infection	1/81 (1.2%)		0/44 (0%)
Herpes Zoster Disseminated	1/81 (1.2%)		0/44 (0%)
Pharyngitis	1/81 (1.2%)		0/44 (0%)
Pneumonia	7/81 (8.6%)		2/44 (4.5%)
Pneumonia Fungal	0/81 (0%)		1/44 (2.3%)
Pseudomonas Infection	0/81 (0%)		1/44 (2.3%)
Respiratory Syncytial Virus Infection	0/81 (0%)		1/44 (2.3%)
Sepsis	8/81 (9.9%)		1/44 (2.3%)
Septic Shock	4/81 (4.9%)		0/44 (0%)
Sinusitis	1/81 (1.2%)		0/44 (0%)
Urinary Tract Infection	1/81 (1.2%)		0/44 (0%)
Injury, poisoning and procedural complications
Subdural Haematoma	1/81 (1.2%)		0/44 (0%)
Investigations
Ejection Fraction Decreased	1/81 (1.2%)		0/44 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/81 (1.2%)		0/44 (0%)
Musculoskeletal Chest Pain	1/81 (1.2%)		0/44 (0%)
Myalgia	1/81 (1.2%)		0/44 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia	4/81 (4.9%)		2/44 (4.5%)
Nervous system disorders
Cerebral Haemorrhage	1/81 (1.2%)		0/44 (0%)
Convulsion	0/81 (0%)		1/44 (2.3%)
Syncope	0/81 (0%)		1/44 (2.3%)
Renal and urinary disorders
Renal Failure Acute	1/81 (1.2%)		1/44 (2.3%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	1/81 (1.2%)		0/44 (0%)
Acute Respiratory Failure	1/81 (1.2%)		0/44 (0%)
Epistaxis	1/81 (1.2%)		0/44 (0%)
Lung Infiltration	1/81 (1.2%)		0/44 (0%)
Respiratory Distress	2/81 (2.5%)		0/44 (0%)
Respiratory Failure	1/81 (1.2%)		0/44 (0%)
Skin and subcutaneous tissue disorders
Blister	0/81 (0%)		1/44 (2.3%)
Hidradenitis	1/81 (1.2%)		0/44 (0%)
Rash	2/81 (2.5%)		0/44 (0%)
Vascular disorders
Deep Vein Thrombosis	1/81 (1.2%)		1/44 (2.3%)
Hypotension	2/81 (2.5%)		0/44 (0%)
Subclavian Vein Thrombosis	1/81 (1.2%)		0/44 (0%)
Thrombophlebitis	1/81 (1.2%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	CPX-351		Salvage Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/81 (100%)		44/44 (100%)
Blood and lymphatic system disorders
Anaemia	5/81 (6.2%)		1/44 (2.3%)
Febrile Neutropenia	41/81 (50.6%)		13/44 (29.5%)
Lymphadenopathy	7/81 (8.6%)		0/44 (0%)
Neutropenia	5/81 (6.2%)		1/44 (2.3%)
Thrombocytopenia	3/81 (3.7%)		3/44 (6.8%)
Cardiac disorders
Pericardial Effusion	5/81 (6.2%)		1/44 (2.3%)
Tachycardia	15/81 (18.5%)		7/44 (15.9%)
Gastrointestinal disorders
Abdominal Discomfort	5/81 (6.2%)		2/44 (4.5%)
Abdominal Distension	13/81 (16%)		2/44 (4.5%)
Abdominal Pain	17/81 (21%)		9/44 (20.5%)
Abdominal Pain Upper	3/81 (3.7%)		3/44 (6.8%)
Constipation	34/81 (42%)		12/44 (27.3%)
Diarrhoea	31/81 (38.3%)		26/44 (59.1%)
Dry Mouth	5/81 (6.2%)		3/44 (6.8%)
Dyspepsia	8/81 (9.9%)		5/44 (11.4%)
Flatulence	6/81 (7.4%)		0/44 (0%)
Haemorrhoids	4/81 (4.9%)		3/44 (6.8%)
Mouth Haemorrhage	5/81 (6.2%)		3/44 (6.8%)
Nausea	44/81 (54.3%)		23/44 (52.3%)
Oral Pain	4/81 (4.9%)		3/44 (6.8%)
Stomatitis	8/81 (9.9%)		6/44 (13.6%)
Vomiting	35/81 (43.2%)		16/44 (36.4%)
Abdominal pain lower	4/81 (4.9%)		3/44 (6.8%)
General disorders
Asthenia	11/81 (13.6%)		9/44 (20.5%)
Catheter Site Erythema	7/81 (8.6%)		4/44 (9.1%)
Catheter Site Pain	14/81 (17.3%)		3/44 (6.8%)
Chest Pain	6/81 (7.4%)		1/44 (2.3%)
Chills	24/81 (29.6%)		10/44 (22.7%)
Fatigue	33/81 (40.7%)		16/44 (36.4%)
Mucosal Inflammation	15/81 (18.5%)		9/44 (20.5%)
Oedema Peripheral	34/81 (42%)		11/44 (25%)
Pain	9/81 (11.1%)		4/44 (9.1%)
Pyrexia	24/81 (29.6%)		13/44 (29.5%)
Immune system disorders
Drug Hypersensitivity	4/81 (4.9%)		4/44 (9.1%)
Infections and infestations
Bacteraemia	4/81 (4.9%)		3/44 (6.8%)
Cellulitis	8/81 (9.9%)		4/44 (9.1%)
Pneumonia	11/81 (13.6%)		4/44 (9.1%)
Urinary tract infection bacterial	0/81 (0%)		3/44 (6.8%)
Enterococcal bacteraemia	3/81 (3.7%)		4/44 (9.1%)
Staphylococcal bacteraemia	6/81 (7.4%)		1/44 (2.3%)
Urinary tract infection enterococcal	2/81 (2.5%)		3/44 (6.8%)
Injury, poisoning and procedural complications
Allergic Transfusion Reaction	5/81 (6.2%)		1/44 (2.3%)
Procedural Pain	4/81 (4.9%)		3/44 (6.8%)
Transfusion Reaction	3/81 (3.7%)		6/44 (13.6%)
Investigations
Weight Decreased	5/81 (6.2%)		2/44 (4.5%)
Metabolism and nutrition disorders
Decreased Appetite	26/81 (32.1%)		15/44 (34.1%)
Hyperglycaemia	4/81 (4.9%)		3/44 (6.8%)
Hypoalbuminaemia	0/81 (0%)		3/44 (6.8%)
Hypokalaemia	19/81 (23.5%)		5/44 (11.4%)
Hypomagnesaemia	8/81 (9.9%)		3/44 (6.8%)
Hypnoatraemia	4/81 (4.9%)		4/44 (9.1%)
Hypophosphataemia	7/81 (8.6%)		1/44 (2.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	14/81 (17.3%)		3/44 (6.8%)
Bone Pain	7/81 (8.6%)		1/44 (2.3%)
Myalgia	6/81 (7.4%)		2/44 (4.5%)
Back pain	15/81 (18.5%)		6/44 (13.6%)
Musculoskeletal pain	4/81 (4.9%)		3/44 (6.8%)
Neck pain	9/81 (11.1%)		1/44 (2.3%)
Pain in extremity	10/81 (12.3%)		6/44 (13.6%)
Nervous system disorders
Dizziness	16/81 (19.8%)		5/44 (11.4%)
Dysgeusia	4/81 (4.9%)		5/44 (11.4%)
Headache	23/81 (28.4%)		15/44 (34.1%)
Peripheral Sensory Neuropathy	7/81 (8.6%)		1/44 (2.3%)
Syncope	2/81 (2.5%)		3/44 (6.8%)
Psychiatric disorders
Anxiety	20/81 (24.7%)		6/44 (13.6%)
Depression	13/81 (16%)		2/44 (4.5%)
Insomnia	14/81 (17.3%)		10/44 (22.7%)
Renal and urinary disorders
Dysuria	6/81 (7.4%)		3/44 (6.8%)
Reproductive system and breast disorders
Vaginal Haemorrhage	6/81 (7.4%)		1/44 (2.3%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	5/81 (6.2%)		1/44 (2.3%)
Cough	25/81 (30.9%)		10/44 (22.7%)
Dyspnoea	22/81 (27.2%)		4/44 (9.1%)
Epistaxis	11/81 (13.6%)		12/44 (27.3%)
Hypoxia	10/81 (12.3%)		1/44 (2.3%)
Oropharyngeal Pain	13/81 (16%)		6/44 (13.6%)
Pleural Effusion	12/81 (14.8%)		2/44 (4.5%)
Pleuritic Pain	6/81 (7.4%)		1/44 (2.3%)
Rales	7/81 (8.6%)		1/44 (2.3%)
Skin and subcutaneous tissue disorders
Alopecia	2/81 (2.5%)		5/44 (11.4%)
Erythema	5/81 (6.2%)		2/44 (4.5%)
Hyperhidrosis	9/81 (11.1%)		3/44 (6.8%)
Night Sweats	6/81 (7.4%)		3/44 (6.8%)
Petechiae	10/81 (12.3%)		6/44 (13.6%)
Pruritus	15/81 (18.5%)		4/44 (9.1%)
Rash	37/81 (45.7%)		11/44 (25%)
Rash erythematous	6/81 (7.4%)		1/44 (2.3%)
Rash maculo-papular	5/81 (6.2%)		1/44 (2.3%)
Rash pruritic	5/81 (6.2%)		1/44 (2.3%)
Vascular disorders
Deep Vein Thrombosis	5/81 (6.2%)		1/44 (2.3%)
Hypertension	11/81 (13.6%)		6/44 (13.6%)
Hypotension	18/81 (22.2%)		6/44 (13.6%)

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.