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Acute Myeloid Leukemia (AML)Phase 1/2NCT00890929

Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

A Phase 1/2 study testing Lenalidomide and Azacitidine in people with Acute Myeloid Leukemia (AML) and Adult Acute Myeloblastic Leukemia, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study has a phase 1 and a phase 2 component. In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine. In phase 2, the objective is to determine the efficacy of the combination treatment. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Lenalidomide and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Apr 2009to Jun 2012
Phase
Phase 1/2
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • WHO-confirmed acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL)
  • White blood cell count (WBC) at initiation of treatment ≤ 10,000
  • ◦If WBC is > 10,000 patients may be started on an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC < 10,000, at which time the hydroxyurea will be discontinued for 24 hours prior to enrollment
  • Age ≥ 60 years and not a candidate for allogeneic stem cell transplantation
  • Unwilling or unable to receive conventional chemotherapy
  • No prior therapy, except supportive care measures such as growth factor support, blood product transfusions, apheresis, or hydroxyurea
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  • ECOG performance status ≤ 2
  • Life expectancy > 2 months
  • All study participants must be registered into the mandatory RevAssist® program, and must be willing and able to comply with the requirements of RevAssist
  • If a female of childbearing potential (FCBP):
  • Must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to study enrollment and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days)
  • Must commit to either continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before starting lenalidomide.
  • Must also agree to ongoing pregnancy testing.
  • Male partners must use a latex condom during sexual contact, including if the male partners has previously had a successful vasectomy.
  • Able to adhere to the study visit schedule and other protocol requirements
  • Willing and able to understand and voluntarily sign a written informed consent

Who cannot join

  • Relapsed or refractory disease
  • Prior therapy with lenalidomide
  • History of intolerance to thalidomide or development of erythema nodosum while taking thalidomide or similar drugs
  • Known or suspected hypersensitivity to azacitidine or mannitol
  • Advanced malignant hepatic tumors
  • Concomitant treatment with other anti-neoplastic agents, except hydroxyurea
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  • Anti-neoplastic treatment less than four weeks prior to enrollment, except hydroxyurea
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Inability to swallow or absorb drug
  • Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
  • New York Heart Association Class III or IV heart failure
  • Unstable angina pectoris
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled psychiatric illness that would limit compliance with requirements
  • Known HIV infection
  • If female:
  • Pregnant
  • Breast-feeding females, if they do not agree to not breastfeed while taking lenalidomide
  • Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
  • Laboratory abnormalities:
  • Creatinine ≥ 1.5 mg/dL
  • Creatinine clearance ≤ 50 mL/min
  • Total bilirubin > 1.5 x institutional upper limit of normal (ULN), except documented Gilbert's syndrome
  • AST > 2.5 x institutional ULN
  • ALT > 2.5 x institutional ULN

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia

This study has a phase 1 and a phase 2 component.

In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.

In phase 2, the objective is to determine the efficacy of the combination treatment.

Read the detailed description

The treatment regimen in this study is 7 day courses of azacitidine 75 mg/m2 followed by a 21-day courses of lenalidomide. For the primary objective, each 28-day cycle was repeated for a total of up to 6 cycles. Study completion was defined as 18 cycles of treatment, disease progression, or death.

In phase 1, the objective was to determine the maximum tolerated dose (MTD) of lenalidomide 5 mg, 10 mg, 25 mg or 50 mg, when administered after azacitidine.

In phase 2, the objective was to assess the efficacy of MTD lenalidomide administered after azacitidine, in up to six 28-day cycles.

Keywords
Acute myeloid leukemia, Acute myeloblastic leukemia, AML
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.

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

  • AzacitidineDrug

    Also called 5-azacytidine, Vidaza

    75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Study groups in NCT00890929
Study groupRoleWhat they receive
Azacitidine followed by lenalidomideExperimentalDose escalation then dose expansion
Receives: Drug: Lenalidomide; Drug: Azacitidine

What is being measured

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

  1. Compete Remission (CR) Rate

    Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.

    Measured: 12 months

Secondary outcomes (8)

  1. 4-week Survival Rate

    "Early death" was assessed as death within 28 days of the start of treatment

    Measured: 28 days

  2. Maximum Tolerated Dose (MTD) of Lenalidomide

    The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.

    Measured: 15 months

  3. Remission Duration

    Responses and remission were assessed according to the ELN guidelines.

    Measured: 26 months

  4. Overall Response Rate (ORR)

    ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.

    Measured: 26 months

  5. Overall Survival (OS)

    OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.

    Measured: 88 weeks (median)

  6. Time to CR

    CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.

    Measured: 18 weeks

  7. Time to PR

    Responses were assessed according to the ELN guidelines.

    Measured: 36 weeks

  8. OS of Responders

    OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.

    Measured: 88 weeks (median)

Timeline

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

  1. First posted30 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2011
  4. Study completionJun 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00890929
Sponsor's protocol ID
IRB-15611
Other IDs
SU-04242009-2385, RV-AML-0410, HEMAML0011
Status last verified
May 2018
First submitted
28 Apr 2009
Last updated
18 Jun 2018
Data monitoring committee
Yes

Publications

  • Pollyea DA, Zehnder J, Coutre S, Gotlib JR, Gallegos L, Abdel-Wahab O, Greenberg P, Zhang B, Liedtke M, Berube C, Levine R, Mitchell BS, Medeiros BC. Sequential azacitidine plus lenalidomide combination for elderly patients with untreated acute myeloid leukemia. Haematologica. 2013 Apr;98(4):591-6. doi: 10.3324/haematol.2012.076414. Epub 2012 Dec 14.

    PubMed 23242596

  • Pollyea DA, Kohrt HE, Gallegos L, Figueroa ME, Abdel-Wahab O, Zhang B, Bhattacharya S, Zehnder J, Liedtke M, Gotlib JR, Coutre S, Berube C, Melnick A, Levine R, Mitchell BS, Medeiros BC. Safety, efficacy and biological predictors of response to sequential azacitidine and lenalidomide for elderly patients with acute myeloid leukemia. Leukemia. 2012 May;26(5):893-901. doi: 10.1038/leu.2011.294. Epub 2011 Oct 28.

    PubMed 22033493

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide and Azacitidine in people with Acute Myeloid Leukemia (AML) and Adult Acute Myeloblastic Leukemia, run by Stanford University at 1 site 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 16 inclusion and 25 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Oct 2014). 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?

Compete Remission (CR) Rate (time frame: 12 months). 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 NCT00890929, which also lists 2 linked publications.

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 Jun 2018.

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