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Acute Myelogenous LeukemiaPhase 2NCT00967512

Aezea® (Cenersen) and Chemotherapy for AML Subjects ≥ 55 Years of Age With No Response to Frontline Induction Course

A Phase 2 study testing cenersen and idarubicin, cytarabine in people with Acute Myelogenous Leukemia, run by Eleos, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess whether treatment with cenersen in combination with 4 cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show a response (CR, CRi, or PR) to a single… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Acute Myelogenous Leukemia
What is being tested?
cenersen and idarubicin, cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2012to Jan 2012
Phase
Phase 2
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In response to their first course of frontline treatment, patients who did not achieve a response (CR, CRi, or PR) and have ≥ 15% bone marrow blasts in a BM specimen between day 14 - 42 from the initiation of a single frontline course. If within that timeframe the BM is hypoplastic, the BM assessment can be repeated within a subsequent two-week period and the patient entered into the study if there is ≥ 15% blasts in the bone marrow.
  • ≥ 55 years old
  • Have an understanding of the importance of not taking paracetamol (acetaminophen) or high dose antioxidants from 1 day before through 1 day after treatment during any given course
  • Have a life expectancy of more than 4 weeks following initiation of treatment
  • Secondary AML is allowed as are antecedent hematologic disorders
  • Zubrod performance status ≤ 2
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  • Have recovered from acute toxicities of prior chemotherapy (≤ Grade 2)
  • Have signed an informed consent
  • Total bilirubin ≤ 1.5 x upper normal limit (UNL) and Alanine Amino Transferase [ALT (Serum Glutamic-pyruvic Transaminase (SGPT))] ≤ 2.5 x UNL
  • Creatinine ≤ 1.5 x UNL
  • Serum magnesium should be within the normal range (Mg replacement being acceptable)
  • Left Ventricular Ejection Fraction (LVEF) of >50% as determined by multiple-gated acquisition scan (MUGA) or Echocardiogram (ECHO)
  • Ability to receive all courses of therapy, as outlined in the treatment schedules at the investigative site
  • Willingness to comply with scheduled follow-up as required by the protocol
  • Use of adequate contraceptive techniques if premenopausal and sexually active; examples include implantable, injectable or oral contraceptives, intrauterine devices (IUD), sterilization, or sexual abstinence
  • If premenopausal, have negative pregnancy tests at screening

Who cannot join

  • Presence of any pneumonia regardless of severity or other life-threatening illness including, but not limited to, ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, high blood pressure, history of labile hypertension, history of poor compliance with an antihypertensive regimen, myocardial infarction less than or equal to 6 months prior to registration, diabetes, or extensive and symptomatic interstitial fibrosis of lung, chronic liver disease or psychiatric illness/social situations that limits compliance with study requirements
  • Acute promyelocytic leukemia (APL [FAB classification M3])
  • Requirement for transplant before Course 2 is complete
  • Concurrent use of other experimental agents (i.e., drugs not approved for clinical indications) or having received other investigational agents within the 30 days prior to the start of Course 1
  • Pregnancy (includes a positive pregnancy test at the screening visit) or lactation
  • Known HIV infection
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  • Active hepatitis B or C or other active liver disease
  • Presence of dyspnea at rest or with minimal exertion after correction for anemia
  • Known or suspected hypersensitivity or allergy to idarubicin or ara-C
  • Occurrence of major surgery within two weeks of the start of Course 1
  • Chemotherapy within two weeks prior to initiation of therapy under this protocol, or hydroxyurea within 7 days
  • Patients who, with appropriate explanation, are not prepared to exclude the use of paracetamol (acetaminophen) or paracetamol-containing medications from 1 day before through 1 day after treatment during any course
  • Patients who are not prepared to commit to the exclusion of high dose antioxidants from 1 day before through 1 day after treatment during any given course
  • Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol or to complete the study
  • Inability, in the opinion of the principal investigator or clinical staff, to comply with protocol requirements for the duration of the study

About this study

Official title: Aezea (Cenersen) in Combination With Chemotherapy for Treatment of Acute Myelogenous Leukemia Subjects ≥55 Years of Age With No Response to Single Frontline Induction Course in a Randomized Double-Blind Placebo-Controlled Multi-Center Study

The purpose of this study is to assess whether treatment with cenersen in combination with 4 cycles of high and low-dose chemotherapy (idarubicin and cytarabine) improves the complete response rate in acute myelogenous leukemia (AML) patients ≥ 55 years of age who did not show a response (CR, CRi, or PR) to a single aggressive frontline induction course.

Read the detailed description

Cenersen is a phosphorothioate antisense oligonucleotide of sequence 5'-CCCTG5-CTCCC10-CCCTG15-GCTCC20-3'. For AML, cenersen is specific for blocking p53 expression in the stem cells. When AML stem cells are dividing, cenersen sensitizes them to even low-level DNA damage of the type caused by idarubicin, etoposide and possibly ara-C.

Because AML stem cells are not all dividing at any given time, this protocol is designed to treat patients with a total of four cycles of cenersen plus chemotherapy within a two to three month period. For a limited period of time, proliferating non-stem cells can be expected to maintain or even expand the tumor while the stem cells are being depleted. If the proliferating non-stem cells are not resupplied by the stem cells, they will all become end stage blasts after a few divisions and undergo elimination.

Being tested
cenersen, placebo, idarubicin, cytarabine
Keywords
Oligonucleotides, Antisense, Tumor Suppressor Protein p53, idarubicin, cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cenersenDrug

    Also called Aezea®, cenersen sodium, EL625

    solution for injection, intravenous infusion, 0.1 mg/kg/h x 24h x 4 days, and 0.4 mg/kg/h x 3h x 4 days

  • placeboDrug

    Also called saline

    solution for injection, intravenous infusion, 0.1 mg/kg/h x 24h x 4 days, and 0.4 mg/kg/h x 3h x 4 days

  • idarubicin, cytarabineDrug

    Also called idamycin, Ara-C

    idarubicin, cytarabine

Study groups in NCT00967512
Study groupRoleWhat they receive
cenersen, idarubicin, cytarabineExperimentalcenersen, idarubicin, cytarabine
Receives: Drug: cenersen; Drug: idarubicin, cytarabine
placebo, idarubicin, cytarabinePlacebo comparatorplacebo, idarubicin, cytarabine
Receives: Drug: placebo; Drug: idarubicin, cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Remission Rate

    Measured: within day 28-42 of Course 1, and within day 28-42 of Course 2

Secondary outcomes (10)

  1. Overall Survival

    Measured: 2 years

  2. Safety Profile

    Measured: up to 2 years

  3. Complete Remission + Complete Remission with Incomplete Blood Count Recovery Rate

    Measured: within day 28-42 of Course 1, and within day 28-42 of Course 2

  4. Morphologic Leukemia-Free State Rate

    Measured: within day 28-42 of Course 1, and within day 28-42 of Course 2

  5. Partial Remission Rate

    Measured: within day 28-42 of Course 1, and within day 28-42 of Course 2

  6. Remission Duration

    Measured: 2 years

  7. Early deaths measured as deaths at 30, 60 and 90 days of the start of treatment

    Measured: 30, 90, and 90 days from start of treatment

  8. Time to Neutrophil and Platelet Recovery

    Measured: within day 28-42 of Course 1, and within day 28-42 of Course 2

  9. Death in Complete Remission

    Measured: 2 years

  10. Zubrod Score

    Measured: during Frontline Assessment (screening); Course 1: on days 6, 15, 18, and within day 28-42; Course 2: on days 1, 7, 15, 18, and within day 28-42; Course 3: on days 1 and 6; and Course 4: on days 1 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2009 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2012 (estimated)
  4. Study completionJan 2012

Why it stopped: Study Was Terminated due to lack of Funding.

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00967512
Sponsor's protocol ID
ELP1020
Other IDs
2008-002160-34, 2008
Status last verified
Sep 2014
First submitted
26 Aug 2009
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cenersen and idarubicin, cytarabine in people with Acute Myelogenous Leukemia, run by Eleos, Inc..

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 16 inclusion and 15 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: withdrawn, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Complete Remission Rate (time frame: within day 28-42 of Course 1, and within day 28-42 of Course 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00967512.

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 18 Sep 2014.

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