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Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Phase 2 trial testing Fludarabine in Acute Myeloid Leukemia in 35 participants. Completed in 13 February 2024.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 13 November 2015 |
| Primary completion | 13 February 2024 |
| Estimated completion | 13 February 2024 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
18 and older, any sex, with Acute Myeloid Leukemia or 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.
OS will be estimated using Kaplan-Meier curves. The 1-year OS rate and corresponding 95% confidence interval will be estimated from the Kaplan-Meier curve for the OS.
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 74 | 54 – 86 |
Will be reported descriptively. RRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 13 | 4 – 28 |
Will be reported descriptively. NRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 16 | 6 – 31 |
Will be reported descriptively
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 27 | 13 – 43 |
Will be reported descriptively
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 97 | 85 – 100 |
Lymphoid reconstitution will be evaluated monthly to every other month during the first year post HSCT and will be reported descriptively.
| Group | Value | 95% CI |
|---|---|---|
| RIC HSCT, GVHD Prophylaxis | 10 | 3 – 25 |
Time frame: Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up 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 | RIC HSCT, GVHD Prophylaxis |
|---|---|---|
| hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Cognitive disturbance | Psychiatric disorders | — |
| Fever | Infections and infestations | — |
| Hypotension | Vascular disorders | — |
| Lung Infection | Hepatobiliary disorders | — |
| Sepsis | Infections and infestations | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| ALT increased | Investigations | — |
| Bilirubin increased | Investigations | — |
| Cardiac Arrest | Cardiac disorders | — |
| Cellulitis | Infections and infestations | — |
| Cholecystitis | Gastrointestinal disorders | — |
| Deliurm | Psychiatric disorders | — |
| Depressed level of Consciousness | Psychiatric disorders | — |
| Ejection Fraction decreased | Cardiac disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hepatobiliary disorder | Hepatobiliary disorders | — |
| Infection & Infestations- Other fever | Infections and infestations | — |
| Nervous System disorder- Aphasia | Nervous system disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| SVT | Cardiac disorders | — |
| Syncope | General disorders | — |
| Urinary Tract Infection | Renal and urinary disorders | — |
| Reaction | System | RIC HSCT, GVHD Prophylaxis |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Fever | Infections and infestations | — |
| Fatigue | General disorders | — |
| Mucositis | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| anorexia | General disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hypotension | Vascular disorders | — |
| sinus tachycardia | Cardiac disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Edema | Cardiac disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Insomnia | Psychiatric disorders | — |
| constipation | Gastrointestinal disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Headache | General disorders | — |
| cough | Respiratory, thoracic and mediastinal disorders | — |
| blood bilirubin increased | Hepatobiliary disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| infusion related reaction | General disorders | — |
| Hypertension | Vascular disorders | — |
| chills | General disorders | — |
| back pain and stiffness | Musculoskeletal and connective tissue disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Depression | Psychiatric disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Renal and urinary disorders- other, decreased urine output | Renal and urinary disorders | — |
| Pruritis | Skin and subcutaneous tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Pain - general | General disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| acute kidney injury | Renal and urinary disorders | — |
| Urine incontinence | Renal and urinary disorders | — |
| Confusion | Psychiatric disorders | — |
| urinary retention | Renal and urinary disorders | — |
| General disorders and administration site conditions- other fluid overload | General disorders | — |
Most-reported serious reactions: hypoxia, Cognitive disturbance, Fever, Hypotension, Lung Infection, Sepsis, Abdominal Pain, Acute Kidney Injury.
Data from ClinicalTrials.gov NCT02566304 adverse events section.
This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the growth of cancer 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 cells (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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