Acute Myeloid LeukemiaPhase 2NCT00822094
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
A Phase 2 study testing CPX-351 and Intensive Salvage Therapy in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 42 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CPX-351 and Intensive Salvage Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 42 sitesin 4 countries
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
42 sites in 4 countries.
42 sites in 4 countries
United States31 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21231
St. Francis Cancer Center
Beech Grove, Indiana, 46107
Oncology and Hematology at Lehigh Valley
Bethlehem, Pennsylvania, 18105
Blumenthal Cancer Center/Mecklenburg Medical Group
Charlotte, North Carolina, 28204
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center Section of Hematology/Oncology
Chicago, Illinois, 60637
Jewish Hospital of Cincinatti
Cincinnati, Ohio
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
UTMB Comprehensive Cancer Center
Galveston, Texas, 77555
The Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
M.D. Anderson Cancer Center
Houston, Texas, 77030
North Shore LIJ Center for Advanced Medicine Monter Cancer Center
Lake Success, New York, 11042
UCLA
Los Angeles, California, 90024
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
Joe Arrington Cancer Center
Lubbock, Texas, 79410
Texas Tech University Health Sciences Center
Lubbock, Texas, 79415
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weil Cornell Medical Center
New York, New York, 10021
New York Medical College
New York, New York, 10595
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
UC Davis Cancer Center
Sacramento, California, 95817
Intermountain LDS Hospital
Salt Lake City, Utah, 84143
Cancer Therapy and Research Center at The University of TX Health Science Center
San Antonio, Texas, 78229
St. Louis University Medical Center
St Louis, Missouri, 63101
Montefiore Medical Center
The Bronx, New York, 10467
Arizona Cancer Center
Tucson, Arizona, 85724
Maine General Medical Center Harold Alfond Center for Cancer Care
Waterville, Maine, 04901
Poland5 sites
Klinika Hematologii i Transplantologii
Gdansk, 80-952
Wojewódzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-510
Oddział Hematologii
Opole, 45-372
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
Akademia Medyczna we Wroclawlu
Wroclaw, 50-367
France4 sites
Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez
Lille, 59037
Service des Maladies du Sang Hopital Haut-Leveque
Pessac, 33604
Service d'Hématologie CHU Toulouse-Hôpital Purpan
Toulouse, 31059
Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
Canada2 sites
Vancouver General Hospital/ British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 1M9
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 049
About this study
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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CPX-351, Intensive Salvage Therapy
- Keywords
- Acute, Myeloid, Leukemia, Adult, First, Relapse, AML, Acute Myelogenous leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Acute myelocytic leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Recurrence, Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-351Drug
Intensive Salvage TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| CPX-351 (Arm A) | Experimental | 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 Receives: Drug: CPX-351 |
| Salvage Therapy (Arm B) | Active comparator | 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 Receives: Drug: Intensive Salvage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Surviving at 1 Year
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.
Measured: Up to 1 year from randomization
Secondary outcomes (5)
Complete Remission Rate
Measured: Following 1st induction, following 2nd induction if applicable
Event Free Survival
Progression EFS median
Measured: Up to 1 year from randomization
Remission Duration
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.
Measured: Following achievement of CR and up to 1 year from randomization
Rate of Aplasia
Patients with Aplasia During Study
Measured: Up to 1 year from randomization
Rate of Stem Cell Transplant
Number of patients transferred for stem cell transplant
Measured: Up to 1 year from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Jonathan Kolitz, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822094
- Sponsor's protocol ID
- CLTR0308-205
- Status last verified
- Oct 2017
- First submitted
- 12 Jan 2009
- Last updated
- 24 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00822094
- Acronym / sponsor ID
- CLTR0308-205
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute, Myeloid, Leukemia, Adult, First, Relapse, AML, Acute Myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPX-351 (Arm A) | Experimental | Drug: CPX-351First 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 |
| Salvage Therapy (Arm B) | Active comparator | Drug: Intensive Salvage TherapyFirst 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPX-351 | Drug | CPX-351 (Arm A) |
| Intensive Salvage Therapy | Drug | Salvage Therapy (Arm B) |
Primary outcome
Proportion of Subjects Surviving at 1 Year
Time frame: 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.
5 secondary outcomes
Complete Remission Rate
Time frame: Following 1st induction, following 2nd induction if applicable
Event Free Survival
Time frame: Up to 1 year from randomization
Remission Duration
Time frame: Following achievement of CR and up to 1 year from randomization
Rate of Aplasia
Time frame: Up to 1 year from randomization
Rate of Stem Cell Transplant
Time frame: Up to 1 year from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Kolitz, MD principal investigator
North Shore University Hospital
42 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPX-351 and Intensive Salvage Therapy in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 42 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Poland, France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Surviving at 1 Year (time frame: Up to 1 year from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.