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Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 2 trial testing decitabine in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome in 20 participants. Completed in 7 October 2017.
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 16 May 2013 |
| Primary completion | 22 July 2017 |
| Estimated completion | 7 October 2017 |
| Sites | 1 location across United States |
University of Wisconsin, Madison
Adults 18 to 75, any sex, with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome or Adult Acute Myeloid Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 64.7 | 45.5 – 91.9 |
Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/ul for three consecutive measurements on different days. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 16 | 16 – 19 |
Platelet recovery is defined as the first day of a platelet count greater than 20,000/mm\^3 with no platelet transfusions. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 58 | 31.3 – 78.4 |
Defined as less than 5% donor chimerism in the cluster of differentiation (CD)3 and CD33 selected cell populations at any time after transplantation. Will be analyzed using KM method.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 0 |
Determined by the standard bone marrow transplant (BMT) Clinical Trials Network criteria (BMTCTN). Will be analyzed using KM method, a Graft versus Host Disease (GVHD) grade III-IV will be obtained from the KM estimates along with 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 27.8 | 8.0 – 52.3 |
Will be summarized with a proportion and a 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 40.7 | 6.9 – 74.0 |
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Decitabine + Bone Marrow Transplant | 141 | 69 – 492 |
Time frame: Adverse Events (AEs) data were collected from registration to 1 year post-transplant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Decitabine (N=20) | Transplant (N=17) |
|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Immune system disorders - Other, specify | Immune system disorders | — | — |
| Anorectal infection | Infections and infestations | — | — |
| Encephalitis infection | Infections and infestations | — | — |
| Enterocolitis infectious | Infections and infestations | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Syncope | Nervous system disorders | — | — |
| Delirium | Psychiatric disorders | — | — |
| Reaction | System | Decitabine (N=20) | Transplant (N=17) |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Platelet Count Decreased | Investigations | — | — |
| White Blood Cell Decreased | Investigations | — | — |
| Neutrophil Count Decreased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Edema limbs | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| GGT increased | Investigations | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Hypertension | Vascular disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
Most-reported serious reactions: Abdominal pain, Diarrhea, Immune system disorders - Other, specify, Anorectal infection, Encephalitis infection, Enterocolitis infectious, Infections and infestations - Other, specify, Sepsis.
Data from ClinicalTrials.gov NCT01707004 adverse events section.
This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving decitabine and total-body irradiation before the transplant together with high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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