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Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R
Phase 2 trial testing aldesleukin in Leukemia in 60 participants. Completed in 16 July 2025.
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 8 February 2000 |
| Primary completion | 31 December 2022 |
| Estimated completion | 16 July 2025 |
City of Hope Medical Center
Adults 16 to 60, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Kaplan-Meier estimates at 2-years post-transplant, with 95% confidence intervals based on logit limit transformation of Greenwood's variance. Outcome is death or relapse, censor is alive in continual complete remission at the date of last clinical disease assessment.
| Group | Value | 95% CI |
|---|---|---|
| HD ARA-C Intermediate Cytogenetics | 0.65 | 0.52 – 0.77 |
Kaplan-Meier estimates at 2-years post-transplant, with 95% confidence intervals based on logit limit transformation of Greenwood's variance. Outcome is death or relapse, censor is alive in continual complete remission at the date of last clinical disease assessment.
| Group | Value | 95% CI |
|---|---|---|
| Unfavorable Risk Cytogenetics | 0.33 | 0.04 – 0.85 |
| Intermediate Risk Cytogenetics | 0.75 | 0.52 – 0.89 |
| Favorable Risk Cytogenetics | 0.75 | 0.44 – 0.92 |
| Unknown Risk: Rejected Cytogenetics Study | 0.73 | 0.41 – 0.91 |
Time frame: Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | HD ARA-C With or Without I… |
|---|---|---|
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | — |
| Cardiac General - Other: CARDIOGENIC SHOCK | Cardiac disorders | — |
| Cardiac General - Other: CONGESTIVE HEART FAILURE | Cardiac disorders | — |
| Cardiac ischemia/infarction | Cardiac disorders | — |
| Myocarditis | Cardiac disorders | — |
| Febrile neutropenia (fever of unknown origin) | Infections and infestations | — |
| Infection, Bacterial (COH) | Infections and infestations | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary/Upper Respiratory - Other: PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary/Upper Respiratory - Other: RESPIRATORY FAILURE DUE TO PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | — |
| Renal/Genitourinary - Other: HEMORRHAGIC CYSTITIS | Renal and urinary disorders | — |
| Reaction | System | HD ARA-C With or Without I… |
|---|---|---|
| Leukocytes (total WBC) for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | — |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — |
| Platelets for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | — |
| Transfusion: Platelets for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | — |
| Transfusion: pRBCs for BMT studies, if specified in the protocol. | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | — |
| Pain | General disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — |
| Lymphopenia | Blood and lymphatic system disorders | — |
| Febrile neutropenia (fever of unknown origin) | Infections and infestations | — |
| Rigors/chills | General disorders | — |
| Esophagitis | Gastrointestinal disorders | — |
| Mood alteration | Nervous system disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Supraventricular and nodal arrhythmia | Cardiac disorders | — |
| Weight loss | General disorders | — |
| Alkaline phosphatase | Metabolism and nutrition disorders | — |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | — |
| Hypotension | Cardiac disorders | — |
| Heartburn/dyspepsia | Gastrointestinal disorders | — |
| Insomnia | General disorders | — |
| Infection, Bacterial (COH) | Infections and infestations | — |
| Edema | Vascular disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Vascular disorders | — |
| Pruritus/itching | Skin and subcutaneous tissue disorders | — |
| Rash/desquamation associated with graft versus host disease (GVHD) | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Adult Respiratory Distress Syndrome (ARDS), Cardiac General - Other: CARDIOGENIC SHOCK, Cardiac General - Other: CONGESTIVE HEART FAILURE, Cardiac ischemia/infarction, Myocarditis, Febrile neutropenia (fever of unknown origin), Infection, Bacterial (COH), Dyspnea (shortness of breath).
Data from ClinicalTrials.gov NCT00534469 adverse events section.
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant. PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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