AzTrials
AzTrials

LeukemiaPhase 3NCT00887068

Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

A Phase 3 study testing Azacitidine in people with Leukemia and AML, run by M.D. Anderson Cancer Center 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
Search all trials

Trial summary

The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The safety of this drug will also be studied. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Leukemia, AML, MDS
What is being tested?
Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteUnited States
Study dates
21 Apr 2009to 20 Aug 2018
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of AML (World Health Organization classification: >=20% blasts in the bone marrow and / or peripheral blood) or MDS (International Prognostic Scoring System intermediate-1 or higher) that at the time of allogeneic transplantation were in: - Induction Failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. Patients with de novo or therapy-related MDS, CMML, or AML are also eligible, regardless of cytogenetics or molecular rearrangements.
  • Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
  • Patients must be in complete remission post transplant.
  • Patient may be enrolled 40 to 100 days after transplant.
  • Age 18 to 75 years old.
  • Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation*. a. Males(mL/min):(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)) b. Females(mL/min):0.85*(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)).
Show all 9Show fewer
  • Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
  • SGPT </= 200 IU/ml unless related to patient's malignancy.
  • Be able to understand and sign informed consent.

Who cannot join

  • Active uncontrolled infection.
  • Presence of uncontrolled graft-versus-host disease.
  • Patients that underwent allogeneic transplantation as a treatment of graft failure.
  • Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
  • Known or suspected hypersensitivity to azacitidine or mannitol.
  • Patients with advanced malignant hepatic tumors.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The safety of this drug will also be studied.

Read the detailed description

The Study Drug:

Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in a flip of a coin) to 1 of 2 groups.

  • If you are in Group 1, you will receive azacitidine.
  • If you are in Group 2, you will not receive azacitidine.

Study Drug Administration:

If you are in Group 1, you will receive azacitidine through a needle under your skin on Days 1-5 of each cycle.

Each cycle is 28 days long.

Your dose of azacitidine may be lowered or stopped if certain side effects develop.

Study Visits:

About 2 or 3 days before each cycle and, if your doctor thinks it is needed, on Day 3 of each cycle and 1 time during Weeks 2 and 3 of each cycle, blood (about 4 teaspoons each time) will be drawn for routine tests.

At 3, 6, and 12 months after the stem cell transplant:

  • You will have a complete medical history and physical exam.
  • Blood (about 4 teaspoons each time) will be drawn for routine tests.
  • You will have a bone marrow aspiration to check the status of the disease.

You may come back for study visits more often if the doctor thinks it is needed.

While on study, you will need to stay in Houston for about 3 months after the transplant (this is standard after stem cell transplants).

Length of Study:

You will be on study treatment for up to 1 year (up to 12 cycles of azacitidine). You will be taken off study early if you experience intolerable side effects or the disease gets worse.

End-of-Treatment Visit:

After you complete the planned treatment with azacitidine, you will have an end-of-treatment visit:

  • You will have a complete medical history and physical exam.
  • Blood (about 4 teaspoons) will be drawn for routine tests.
  • You will have a bone marrow aspiration to check the status of the disease.

This is an investigational study. Azacitidine is FDA approved and is commercially available for the treatment of myelodysplastic syndrome.

Up to 246 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions
Leukemia, AML, MDS
Being tested
Azacitidine
Keywords
Leukemia, Acute myelogenous leukemia, AML, Myelodysplastic syndrome, MDS, Remission, Allogeneic stem cell transplant, Allotx, Azacitidine, 5-Azacitidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • AzacitidineDrug

    Also called 5-Azacitidine, 5-aza, Vidaza, 5-AZC

    32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.

Study groups in NCT00887068
Study groupRoleWhat they receive
AzacitidineExperimentalAzacitidine 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
Receives: Drug: Azacitidine
No AzacitidineNo interventionStandard treatment post allogeneic transplant is supportive care only.

What is being measured

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

  1. Relapse-free Survival (RFS)

    The time that a participant survives without relapse of the disease.

    Measured: 3 years

Secondary outcomes (1)

  1. Overall Survival (OS)

    Measured: 3 years

Timeline

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

  1. First posted23 Apr 2009 (estimated)
  2. Study start21 Apr 2009
  3. Primary completion20 Aug 2018
  4. Study completion20 Aug 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887068
Sponsor's protocol ID
2008-0503
Other IDs
NCI-2012-01259
Status last verified
Jan 2020
First submitted
22 Apr 2009
Last updated
14 Jan 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Oran B, de Lima M, Garcia-Manero G, Thall PF, Lin R, Popat U, Alousi AM, Hosing C, Giralt S, Rondon G, Woodworth G, Champlin RE. A phase 3 randomized study of 5-azacitidine maintenance vs observation after transplant in high-risk AML and MDS patients. Blood Adv. 2020 Nov 10;4(21):5580-5588. doi: 10.1182/bloodadvances.2020002544.

    PubMed 33170934

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azacitidine in people with Leukemia and AML, run by M.D. Anderson Cancer Center 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 9 inclusion and 6 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 14 Jan 2020. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Jan 2020). 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?

Relapse-free Survival (RFS) (time frame: 3 years). 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 NCT00887068, 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 14 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in