Secondary AML401NCT02533115
EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML
A study testing CPX-351 in people with Secondary AML, run by Jazz Pharmaceuticals at 6 sites in United States.
Trial summary
This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Secondary AML
- What is being tested?
- CPX-351
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Ability to understand and voluntarily give informed consent
- Age 60- 75 years
- Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
- Confirmation of:
- Therapy related AML: t-AML must have a history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease
- AML with a history of myelodysplasia
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- AML with a history of CMMoL
- De novo AML with karyotypic abnormalities characteristic of MDS per WHO (see table)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Laboratory values fulfilling the following:
- Serum creatinine < 2.0 mg/dL
- Serum total bilirubin < 2.0 mg/dL
- Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes above the ULN are related to disease, higher levels of ALT and AST may be considered.
- Cardiac ejection fraction ≥ 50% by echocardiography or MUGA
Who cannot join
- Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of registration.
- Clinical evidence of active CNS leukemia
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment.
- Any major surgery or radiation therapy within four weeks.
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- Patients with prior cumulative anthracycline exposure of greater than 368 mg/mP2P daunorubicin (or equivalent).
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
- Patients with myocardial impairment of any cause (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 Criteria (Class III or IV staging)
- Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have post treatment negative culture(s) to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-metabolism disorder
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northside Hospital
Atlanta, Georgia, 30342
Rush University Medical Center
Chicago, Illinois, 60612
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
The University of Kansas Hospital
Kansas City, Kansas, 66160
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Weill Cornell Medical College- NY Presbyterian Hospital
New York, New York, 10021
About this study
Official title: Expanded Access Protocol of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for Patients 60-75 Years of Age With Secondary AML
This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.
Read the detailed description
The hypothesis that CPX-351 treatment may be safe and efficacious in patients with newly diagnosed secondary AML comes from a single randomized Phase II study which observed significant improvement in survival in a 52-patient subset of patients with secondary AML. A Phase III confirmatory study has recently completed accrual and final results are not expected until mid-2016. Therefore, the sponsor has chosen to make CPX-351 available to secondary AML patients through this expanded access protocol until commercialization of CPX-351 or more information about the clinical utility is known.
This study is a Phase IV multicenter, single-arm open-label Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy. Patients may receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, serious adverse events, grade 3 and 4 adverse events, etc.) while on the study and for SAEs for 30 days after the last dose of CPX-351. Study enrollment will be available through commercialization of CPX-351.
- Conditions
- Secondary AML
- Being tested
- CPX-351
- Keywords
- VYXEOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-351Drug
CPX-351 (cytarabine:daunorubicin) Liposome for Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio shown to act synergistically in pre-clinical studies. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio.
CPX-351 is provided as a sterile, pyrogen-free, purple, lyophilized product in 50 mL glass, single-use vials. Each 50 mL vial after reconstitution contains 20 mL of CPX-351 (5 units/mL). Each unit (u) contains 1 mg cytarabine and 0.44 mg daunorubicin base in liposomes suspended in sucrose. Product is stored at 5˚ ± 3PoPC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary AMLStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533115
- Sponsor's protocol ID
- CLTR0314-401
- Acronym
- 401
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
Publications
Roboz GJ, Larson ML, Rubenstein SE, Solomon SR, Schiller GJ, An Q, Chiarella M, Louie AC, Lin TL. Final safety and efficacy results from the CPX-351 early access program for older patients with high-risk or secondary acute myeloid leukemia. Leuk Lymphoma. 2020 May;61(5):1188-1194. doi: 10.1080/10428194.2020.1725503. Epub 2020 Feb 26.
PubMed 32102577
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for Patients 60-75 Years of Age With Secondary AML
- ClinicalTrials.gov ID
- NCT02533115
- Acronym / sponsor ID
- 401 / CLTR0314-401
- Conditions
- Secondary AML
- Keywords
- VYXEOS
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.
Detailed description
The hypothesis that CPX-351 treatment may be safe and efficacious in patients with newly diagnosed secondary AML comes from a single randomized Phase II study which observed significant improvement in survival in a 52-patient subset of patients with secondary AML. A Phase III confirmatory study has recently completed accrual and final results are not expected until mid-2016. Therefore, the sponsor has chosen to make CPX-351 available to secondary AML patients through this expanded access protocol until commercialization of CPX-351 or more information about the clinical utility is known.
This study is a Phase IV multicenter, single-arm open-label Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy. Patients may receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, serious adverse events, grade 3 and 4 adverse events, etc.) while on the study and for SAEs for 30 days after the last dose of CPX-351. Study enrollment will be available through commercialization of CPX-351.
Study design
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to understand and voluntarily give informed consent
- Age 60- 75 years
- Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
- Confirmation of:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (13 listed)
- Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of registration.
- Clinical evidence of active CNS leukemia
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- 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-351CPX-351 (cytarabine:daunorubicin) Liposome for Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio shown to act synergistically in pre-clinical studies. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio. CPX-351 is provided as a sterile, pyrogen-free, purple, lyophilized product in 50 mL glass, single-use vials. Each 50 mL vial after reconstitution contains 20 mL of CPX-351 (5 units/mL). Each unit (u) contains 1 mg cytarabine and 0.44 mg daunorubicin base in liposomes suspended in sucrose. Product is stored at 5˚ ± 3PoPC. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 32102577Roboz GJ, Larson ML, Rubenstein SE, Solomon SR, Schiller GJ, An Q, Chiarella M, Louie AC, Lin TL. Final safety and efficacy results from the CPX-351 early access program for older patients with high-risk or secondary acute myeloid leukemia. Leuk Lymphoma. 2020 May;61(5):1188-1194. doi: 10.1080/10428194.2020.1725503. Epub 2020 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPX-351 in people with Secondary AML, run by Jazz Pharmaceuticals at 6 sites in United States.
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 14 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533115, which also lists 1 linked publication.
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 22 Aug 2017.