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

NCT ID: NCT01786343

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-05
• Study Completion Date: 2019-05-06

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.

Detailed Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 dose levels of decitabine based on when you join this study. If you are among the first 20 participants, you will have an equal chance of being in either group. If you enroll after that, you will have an increasingly higher chance (51-100%) of being assigned to the group that had better results, depending on how much better that treatment arm is.

Study Drug Administration:

Each cycle is about 4-8 weeks, depending on the doctor's decision. In this study you will receive induction therapy to try to control the disease and cause remission (this is when tests and/or the doctor cannot find signs of the disease).

If you are in Group 1, you will receive decitabine by vein over about 1 hour for 5 days.

If you are in Group 2, you will receive decitabine by vein over about 1 hour for 10 days.

If the disease is in remission, you may receive more cycles (called maintenance) to help keep the disease under control. If you are in Group 2, you will receive 5 day dosing during maintenance, or when the doctor thinks it is in your best interest.

Your dose schedule or dose level may be changed if the doctor feels it is in your best interest.

Study Visits:

The following tests and procedures will be performed:

• Blood (about 2-3 teaspoons) will be drawn 1-2 times weekly for first cycle, then every 2-4 weeks after that. After the 6th cycle or sooner if the doctor decides, this blood draw will be performed only 1 time per cycle.
• Every 1-3 cycles, you will have a bone marrow aspiration/biopsy to check the status of the disease. Blood (about 2-3 teaspoons) may also be drawn for genetic testing if the disease is in remission and the doctor thinks it is needed.

Length of Treatment:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up phone calls.

Follow-Up:

After you stop the study treatment, you will be called by phone twice a year and asked how you are feeling. The phone calls should last about 5 minutes each time.

This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Its use to treat AML is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decitabine - 5 Day Regimen

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

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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

Decitabine - 10 Day Regimen

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

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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

Interventions

Decitabine

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

Intervention Type: DRUG

Other Intervention Names

Dacogen

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Performance 0-3 (ECOG).

4. 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).

5. Signed informed consent

Exclusion Criteria

1. 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)

2. Active and uncontrolled infections.

3. 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farhad Ravandi-Kashani, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30545576 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2013-00463

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-1017

Identifier Type: -

Identifier Source: org_study_id