Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)

NCT01786343 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-1017NCI-2013-00463
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Conditions

Leukemia

Keywords

Leukemia; Acute myeloid leukemia; AML; Response rates; Decitabine; Dacogen

Outcome Measures

Primary Outcomes (1)

• Participants With a Response

  Response is defined as Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR is the normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= (1.0 x 10\^9/L, and a platelet count \>/= 100 x 10\^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to \>100 x 10\^9/L and/or granulocyte count \> (1.0 x 10\^9/L). Clinical benefit is platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (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 x 109/L.

  Up to 3 months

Secondary Outcomes (2)

• Overall Survival

  Up to 5 years

• Response Duration

  Up to 5 years

Study Arms (2)

Decitabine - 5 Day Regimen

EXPERIMENTAL

Decitabine 20 mg/m2 by vein daily for 5 days.

Drug: Decitabine

Decitabine - 10 Day Regimen

EXPERIMENTAL

Decitabine 20 mg/m2 by vein daily for 10 days.

Drug: Decitabine

Interventions

Decitabine DRUG

20 mg/m2 by vein daily for either 5 or 10 days.

Also known as: Dacogen

Decitabine - 10 Day Regimen; Decitabine - 5 Day Regimen

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previously untreated AML (by the World Health Organization (WHO) criteria, i.e. \>/= 20% blasts) Prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. Patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
• Patients \>/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian's score (Appendix D) Patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
• Performance 0-3 (ECOG).
• Adequate liver function (Total bilirubin of \< 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or Gilbert's syndrome and renal function (creatinine \< 2.5 mg/dl).
• Signed informed consent

You may not qualify if:

• Nursing and pregnant females. Female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Negative urine pregnancy test (women of childbearing potential)
• Active and uncontrolled infections.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.

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 (1)

• Short NJ, Kantarjian HM, Loghavi S, Huang X, Qiao W, Borthakur G, Kadia TM, Daver N, Ohanian M, Dinardo CD, Estrov Z, Kanagal-Shamanna R, Maiti A, Benton CB, Bose P, Alvarado Y, Jabbour E, Kornblau SM, Pemmaraju N, Jain N, Gasior Y, Richie MA, Pierce S, Cortes J, Konopleva M, Garcia-Manero G, Ravandi F. Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial. Lancet Haematol. 2019 Jan;6(1):e29-e37. doi: 10.1016/S2352-3026(18)30182-0. Epub 2018 Dec 10.

  PMID: 30545576 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; 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: Farhad Ravandi-Kashani MD/Professor
• Organization: The University of Texas MD Anderson Cancer Center

fravandi@mdanderson.org

713-745-0394

Study Officials

• Farhad Ravandi-Kashani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: February 5, 2013
• First Posted: February 7, 2013
• Study Start: February 5, 2013
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: April 15, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-04

Locations

US (1)