Overview

This trial is active, not recruiting.

Condition leukemia
Treatments aldesleukin, filgrastim, busulfan, cytarabine, etoposide, idarubicin, autologous hematopoietic stem cell transplantation, bone marrow transplantation, peripheral blood stem cell transplantation, total-body irradiation
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date January 2000
End date August 2016
Trial size 50 participants
Trial identifier NCT00534469, 99040, CDR0000564772, CHNMC-99040, P30CA033572

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
HD ARA-C with Idarubicin Consolidation, Busulfan/FTBI/VP16/PSC/BMT
aldesleukin
filgrastim
busulfan
cytarabine
etoposide
idarubicin
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
(Active Comparator)
HD ARA-C Consolidation, Busulfan/FTBI/VP16/PSC/BMT
aldesleukin
filgrastim
busulfan
cytarabine
etoposide
autologous hematopoietic stem cell transplantation
bone marrow transplantation
peripheral blood stem cell transplantation
total-body irradiation

Primary Outcomes

Measure
Efficacy of preparative therapy as measured by 2- and 5-year disease-free survival
time frame: 5 years post treatment
Toxicity of preparative therapy
time frame: Day 100 post treatment
Feasibility of administration and ability to tolerate aldesleukin after transplantation
time frame: 5 years post treatment

Secondary Outcomes

Measure
Effect of cytogenetics, WBC at presentation, targeted busulfan dose, and number of courses of induction therapy required to achieve remission on possible prognostic factors for relapse, disease-free survival, and overall survival
time frame: 5 years post treatment

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) - FAB types M0-2 and M4-M7 - No M3 disease - In first complete hematological remission as confirmed by marrow aspiration and biopsy - No cytogenetic abnormality in the remission marrow - In complete remission for less than 6 months - Patients who have been in complete remission for more than 6 months may be eligible upon approval of the principal investigator - No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis, essential thrombocytosis, or polycythemia vera) - No prior myelodysplasia or secondary leukemia PATIENT CHARACTERISTICS: - FEV_1 > 60% - DLCO > 50% - Cardiac ejection fraction ≥ 50% - Creatinine clearance > 60 mL/min - No severe chronic medical or psychological illness that, in the judgement of the principal investigator, would jeopardize the ability of the patient to tolerate aggressive chemotherapy - No HIV positivity - Not pregnant - Negative pregnancy test PRIOR CONCURRENT THERAPY: - Prior consolidation therapy allowed - No concurrent use the following medications during aldesleukin therapy : - Corticosteroids (including blood product "pre-meds") - Pentoxifylline - IV or intrathecal methotrexate - IV immunoglobulin - Other cytokines or growth factors

Additional Information

Official title Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen
Description OBJECTIVES: - To evaluate the efficacy and toxicity of a preparative regimen comprising busulfan, etoposide, and fractionated total-body irradiation followed by autologous stem cell transplantation and aldesleukin after treatment with consolidation therapy comprising high-dose cytarabine with or without idarubicin in patients with acute myeloid leukemia in first remission. - To estimate the long-term disease-free survival of patients treated with this regimen. - To further evaluate the effect of prognostic factors (e.g., cytogenetics, WBC at presentation, and number of courses of induction therapy required to achieve remission) on the outcome of autologous stem cell transplantation and targeted busulfan dose. OUTLINE: - Consolidation therapy: Patients who received prior consolidation therapy are evaluated to determine the need for additional consolidation therapy. Patients who have not received prior consolidation therapy receive high-dose cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin* IV over 5-10 minutes on days 1-3. 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. - Stem cell collection: All patients receive filgrastim (G-CSF) IV or subcutaneously (SC) twice daily beginning 7 days after completion of high-dose cytarabine and continuing until peripheral blood stem cell (PBSC) collection is completed. Patients who do not have an adequate number of PBSCs collected also undergo bone marrow collection. - Preparative regimen: Patients receive busulfan IV over 2 hours on days -13 and -11 to -7 and etoposide IV on day -2. Patients also undergo fractionated total-body irradiation on days -6 to -3 for a total of 8-10 fractions. - Autologous stem cell transplantation: Patients undergo autologous stem cell transplantation using PBSCs (with or without bone marrow) on day 0. Patients receive G-CSF IV or SC daily beginning on day 5 and continuing until blood counts recover. - Interleukin therapy: Within 100 days post-transplantation, patients receive aldesleukin IV continuously on days 1-4 and 9-18. After completion of study treatment, patients are followed periodically.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.