Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

NCT01720225 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-0507NCI-2012-02215
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.

Conditions

Leukemia

Keywords

Leukemia; Myelodysplastic syndromes; MDS; Low and Intermediate-1 Risk Disease; Decitabine; DAC; Dacogen; Azacitidine; AZA; 5-azacytidine; 5-aza; Vidaza; 5-AZC; AZA-CR; Ladakamycin; NSC-102816

Outcome Measures

Primary Outcomes (1)

• Participants With a Response

  Overall Response = complete remission (CR) + partial remission (PR) + marrow CR (mCR) + hematologic improvement (HI). CR is normalization of peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/L, and platelet count \> 100 x 10\^9/L). PR is same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Marrow CR is blasts \</= 5% and decreased by \>/=50% from baseline. HI is platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pre-therapy; or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 X1 0\^9/L.

  56 days

Secondary Outcomes (1)

• Number of Participants Who Became Transfusion Independent

  8 weeks

Study Arms (2)

Decitabine

EXPERIMENTAL

Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.

Drug: Decitabine

Azacitidine

EXPERIMENTAL

Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.

Drug: Azacitidine

Interventions

Decitabine DRUG

20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.

Also known as: DAC, Dacogen

Decitabine

Azacitidine DRUG

75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.

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

Azacitidine

Eligibility Criteria

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

You may qualify if:

• Sign an Institutional Review Board (IRB)-approved informed consent document.
• Age \>/= than18 years
• de novo or secondary International Prostate Symptom Score (IPSS) low- or intermediate-1 - risk MDS, including CMML
• Eastern Cooperative Oncology Group (ECOG) performance status of \</= 3 at study entry.
• Organ function as defined: Serum creatinine \</= 3 x Upper Limit of Normal (ULN), Total bilirubin \</= 2 x ULN, Alanine transaminase (ALT) (SGPT) \</= 2 x ULN
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

You may not qualify if:

• Breast feeding females
• Prior therapy with decitabine or azacitidine

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Sasaki K, Jabbour E, Montalban-Bravo G, Darbaniyan F, Do KA, Class C, Short NJ, Kanagal-Shamana R, Kadia T, Borthakur G, Pemmaraju N, Cortes J, Ravandi F, Alvarado Y, Chien K, Komrokji R, Sekeres MA, Steensma DP, DeZern A, Roboz G, Soltysiak K, Yang H, Kantarjian HM, Garcia-Manero G. Low-Dose Decitabine versus Low-Dose Azacitidine in Lower-Risk MDS. NEJM Evid. 2022 Oct;1(10):EVIDoa2200034. doi: 10.1056/EVIDoa2200034. Epub 2022 Aug 9.

  PMID: 38319837 DERIVED

• Jabbour E, Short NJ, Montalban-Bravo G, Huang X, Bueso-Ramos C, Qiao W, Yang H, Zhao C, Kadia T, Borthakur G, Pemmaraju N, Sasaki K, Estrov Z, Cortes J, Ravandi F, Alvarado Y, Komrokji R, Sekeres MA, Steensma DP, DeZern A, Roboz G, Kantarjian H, Garcia-Manero G. Randomized phase 2 study of low-dose decitabine vs low-dose azacitidine in lower-risk MDS and MDS/MPN. Blood. 2017 Sep 28;130(13):1514-1522. doi: 10.1182/blood-2017-06-788497. Epub 2017 Aug 3.

  PMID: 28774880 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

Decitabine; Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; 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: Elias Joseph MD./Professor
• Organization: The University of Texas MD Anderson Cancer Center

ejabbour@mdanderson.org

713-792-4764

Study Officials

• Elias Jabbour, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: November 6, 2012
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: December 24, 2020
• Results First Posted: December 24, 2020

Record last verified: 2020-12

Locations

US (1)