A Phase 2 interventional study of Decitabine in Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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:
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 74 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Decitabine 20 mg/m2 by vein daily for 5 days.
Drug: Decitabine
Decitabine 20 mg/m2 by vein daily for 10 days.
Drug: Decitabine
20 mg/m2 by vein daily for either 5 or 10 days.
Also known as: Dacogen
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.
Time frame: Up to 3 months
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up.
Time frame: Up to 5 years
Response Duration
The date of response to date of loss of response or last follow-up. 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
Time frame: Up to 5 years
Recruitment Period: February 2013 - April 2018
| Milestone | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| Started | 28 | 46 |
| Completed | 28 | 46 |
| Not completed | 0 | 0 |
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.
| Participants | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| Participants With a Response | 12 | 19 |
Time from date of treatment start until date of death due to any cause or last Follow-up.
| Months | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| Overall Survival | 5.5 (2.1 to 11.7) | 6.0 (1.9 to 11.7) |
The date of response to date of loss of response or last follow-up. 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
| Months | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| Response Duration | 9.4 (5.6 to 17.9) | 6.4 (2.8 to 12.4) |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decitabine - 5 Day Regimen | 5/28 (17.9%) | 20/28 (71.4%) | 22/28 (78.6%) |
| Decitabine - 10 Day Regimen | 16/46 (34.8%) | 37/46 (80.4%) | 39/46 (84.8%) |
| Event | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| DeathGeneral disorders | 3/28 | 16/46 |
| Neutropenic FeverInfections and infestations | 8/28 | 13/46 |
| PneumoniaInfections and infestations | 5/28 | 6/46 |
| Lung InfectionInfections and infestations | 3/28 | 7/46 |
| DiarrheaGastrointestinal disorders | 3/28 | 1/46 |
| BactreamiaInfections and infestations | 2/28 | 0/46 |
| FeverGeneral disorders | 2/28 | 0/46 |
| CellulitisInfections and infestations | 1/28 | 3/46 |
| EdemaGeneral disorders | 0/28 | 3/46 |
| Pulmonary InsufficiencyRespiratory, thoracic and mediastinal disorders | 0/28 | 3/46 |
| Event | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen |
|---|---|---|
| Neutropenic FeverInfections and infestations | 8/28 | 14/46 |
| Opportunistic InfectionInfections and infestations | 7/28 | 13/46 |
| PainGeneral disorders | 2/28 | 10/46 |
| FatigueGeneral disorders | 6/28 | 6/46 |
| Elevated CreatinineInvestigations | 5/28 | 1/46 |
| InfectionInfections and infestations | 2/28 | 7/46 |
| Muscle WeaknessMusculoskeletal and connective tissue disorders | 1/28 | 6/46 |
| DiarrheaGastrointestinal disorders | 3/28 | 1/46 |
| NauseaGastrointestinal disorders | 2/28 | 4/46 |
| HyperbilirubinemiaInvestigations | 2/28 | 0/46 |
| Age, Categorical(Participants) | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 25 | 46 | 71 |
| Age, Continuous(years) | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen | Total |
|---|---|---|---|
| Median | 77 (57 to 85) | 78 (65 to 94) | 78 (57 to 94) |
| Sex: Female, Male(Participants) | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 16 | 32 | 48 |
| Race (NIH/OMB)(Participants) | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 7 | 9 |
| White | 22 | 36 | 58 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Decitabine - 5 Day Regimen | Decitabine - 10 Day Regimen | Total |
|---|---|---|---|
| United States | 28 | 46 | 74 |
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M.D. Anderson Cancer Center