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

NCT00887068 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2008-0503NCI-2012-01259
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; AML; MDS

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

Outcome Measures

Primary Outcomes (1)

• Relapse-free Survival (RFS)

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

  3 years

Secondary Outcomes (1)

• Overall Survival (OS)

  3 years

Study Arms (2)

Azacitidine

EXPERIMENTAL

Azacitidine 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.

Drug: Azacitidine

No Azacitidine

NO INTERVENTION

Standard treatment post allogeneic transplant is supportive care only.

Interventions

Azacitidine DRUG

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.

Also known as: 5-Azacitidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816

Azacitidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 33170934 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Richard E. Champlin, MD/ Chair, Stem Cell Transplantation
• Organization: UT MD Anderson Cancer Center

rchampli@mdanderson.org

713-792-3618

Study Officials

• Richard E. Champlin, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: April 21, 2009
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Locations

US (1)