A Phase 2 interventional study of aldesleukin and filgrastim in Leukemia, sponsored by City of Hope Medical Center. Completed. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE:
NOTE: *Patients with good risk cytogenetics t(8;21), inv(16), or t(16;16) or patients who received > 200 mg/m² of anthracycline do not receive idarubicin.
After completion of study treatment, patients are followed periodically.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
Compared within Leukemia, Myeloid, Acute, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML)
FAB types M0-2 and M4-M7
In first complete hematological remission as confirmed by marrow aspiration and
In complete remission for less than 6 months
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent use the following medications during aldesleukin therapy :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study was designed as a single-arm study. Strata were: HD ARA-C w/ Idarubicin, CR\<6 months N = 24 patients. HD ARA-C w/ Idarubicin, CR\>6 months N=1. HD ARA-C consolidation, CR\<6 months N=5. HD ARA-C consolidation, CR\>6 months N= 0.
Biological: aldesleukin · Biological: filgrastim · Drug: busulfan · Drug: cytarabine · Drug: etoposide · Drug: idarubicin · Procedure: autologous hematopoietic stem cell transplantation · Procedure: bone marrow transplantation · Procedure: peripheral blood stem cell transplantation · Radiation: total-body irradiation
Also known as: Proleukin
Also known as: Neupogen
Also known as: Myleran, Busulfex IV
Also known as: cytosine arabinoside, ara-C, arabinofuranosyl cytidine, Cytosar-U
Also known as: VP-16, Vepesid, Toposar, Etophosphos
Also known as: Idamycin, Zavedos, 4-demethoxydaunorubicin
Disease-Free Survival at 2-Year Post-Transplant
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.
Time frame: Estimate at 2 years post treatment
Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk
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.
Time frame: Kaplan-Meier estimate 2 years post treatment
60 patients went on-study. 52 went on to autologous transplant. Seven completed consolidation therapy without moving on to transplant. One was given an allogeneic transplant.
| Milestone | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
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.
| Proportion of pts alive in remission | HD ARA-C Intermediate Cytogenetics |
|---|---|
| Disease-Free Survival at 2-Year Post-Transplant | 0.65 (0.52 to 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.
| Proportion of pts alive in remission | Unfavorable Risk Cytogenetics | Intermediate Risk Cytogenetics | Favorable Risk Cytogenetics | Unknown Risk: Rejected Cytogenetics Study |
|---|---|---|---|---|
| Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk | 0.33 (0.04 to 0.85) | 0.75 (0.52 to 0.89) | 0.75 (0.44 to 0.92) | 0.73 (0.41 to 0.91) |
Collected over Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HD ARA-C With or Without Idarubicin | 37/60 (61.7%) | 6/60 (10%) | 47/60 (78.3%) |
| Event | HD ARA-C With or Without Idarubicin |
|---|---|
| Adult Respiratory Distress Syndrome (ARDS)Respiratory, thoracic and mediastinal disorders | 2/60 |
| Cardiac General - Other: CARDIOGENIC SHOCKCardiac disorders | 1/60 |
| Cardiac General - Other: CONGESTIVE HEART FAILURECardiac disorders | 1/60 |
| Cardiac ischemia/infarctionCardiac disorders | 1/60 |
| MyocarditisCardiac disorders | 1/60 |
| Febrile neutropenia (fever of unknown origin)Infections and infestations | 1/60 |
| Infection, Bacterial (COH)Infections and infestations | 1/60 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 1/60 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/60 |
| Pulmonary/Upper Respiratory - Other: PULMONARY HYPERTENSIONRespiratory, thoracic and mediastinal disorders | 1/60 |
| Event | HD ARA-C With or Without Idarubicin |
|---|---|
| Leukocytes (total WBC) for BMT studies, if specified in the protocol.Blood and lymphatic system disorders | 46/60 |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.Blood and lymphatic system disorders | 45/60 |
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 45/60 |
| Calcium, serum-low (hypocalcemia)Metabolism and nutrition disorders | 44/60 |
| Platelets for BMT studies, if specified in the protocol.Blood and lymphatic system disorders | 43/60 |
| Transfusion: Platelets for BMT studies, if specified in the protocol.Blood and lymphatic system disorders | 43/60 |
| Transfusion: pRBCs for BMT studies, if specified in the protocol.Blood and lymphatic system disorders | 43/60 |
| NauseaGastrointestinal disorders | 43/60 |
| VomitingGastrointestinal disorders | 42/60 |
| Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders | 42/60 |
Patients who went on to autologous transplant.
| Age, Categorical(Participants) | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 50 |
| >=65 years | 0 |
| Age, Continuous(years) | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| Median | 42.3 (16.5 to 59.7) |
| Sex: Female, Male(Participants) | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| Female | 31 |
| Male | 21 |
| Race/Ethnicity, Customized(Participants) | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| Race/Ethnicity — American Indian or Alaska Native, not of Hispanic Origin | 1 |
| Race/Ethnicity — Asian or Pacific Islander, not of Hispanic Origin | 3 |
| Race/Ethnicity — Black, not of Hispanic Origin | 2 |
| Race/Ethnicity — Hispanic | 6 |
| Race/Ethnicity — White, not of Hispanic Origin | 40 |
| Region of Enrollment(participants) | HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. |
|---|---|
| United States | 52 |
No study locations are listed for this record.
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Studies of the drugs tested here: Busulfan · Etoposide