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Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
NA trial testing fludarabine phosphate in Accelerated Phase Chronic Myelogenous Leukemia in 62 participants. Completed in 13 March 2019.
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 14 January 2009 |
| Primary completion | 9 August 2012 |
| Estimated completion | 13 March 2019 |
| Sites | 1 location across United States |
Roswell Park Cancer Institute
Adults 3 to 75, any sex, with Accelerated Phase Chronic Myelogenous Leukemia or Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 8.44 | 3.08 – 17.29 |
Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 16.5 | 0 – 26 |
Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 17.0 | 0 – 74 |
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 89 |
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 94 |
Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 27 | 16 – 38 |
1 yr Extensive Chronic GVHD Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 60 | 45 – 73 |
3 yr Overall Survival estimated using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | 46.0 | 33.0 – 57.0 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Reduced Intensi… |
|---|---|---|
| Hospitalisation | Surgical and medical procedures | — |
| Graft versus host disease | Immune system disorders | — |
| Death | General disorders | — |
| Pyrexia | General disorders | — |
| Cardiac disorder | Cardiac disorders | — |
| Bacteraemia | Infections and infestations | — |
| Infection | Infections and infestations | — |
| Haematuria | Renal and urinary disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Vascular disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Atrial tachycardia | Cardiac disorders | — |
| Cardio-respiratory arrest | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Disease progression | General disorders | — |
| Multi-organ failure | General disorders | — |
| Pain | General disorders | — |
| Cellulitis | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Cerebral haemorrhage | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Anuria | Renal and urinary disorders | — |
| Urinary tract disorder | Renal and urinary disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Hospitalisation, Graft versus host disease, Death, Pyrexia, Cardiac disorder, Bacteraemia, Infection, Haematuria.
Data from ClinicalTrials.gov NCT00856388 adverse events section.
This clinical trial is studying how well giving fludarabine phosphate and melphalan together with total-body irradiation followed by donor stem cell transplant works in treating patients with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect)
1 peer-reviewed publication reference this trial (live from Europe PMC):
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