Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R

NCT00534469 | Completed Phase 2 Results

• 4 other identifiers: 99040P30CA033572CHNMC-99040CDR0000564772
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4)

Outcome Measures

Primary Outcomes (1)

• 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.

  Estimate at 2 years post treatment

Secondary Outcomes (1)

• Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk

  Kaplan-Meier estimate 2 years post treatment

Study Arms (1)

HD ARA-C with or without Idarubicin

EXPERIMENTAL

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

Interventions

aldesleukin BIOLOGICAL

Also known as: Proleukin

HD ARA-C with or without Idarubicin

filgrastim BIOLOGICAL

Also known as: Neupogen

HD ARA-C with or without Idarubicin

busulfan DRUG

Also known as: Myleran, Busulfex IV

HD ARA-C with or without Idarubicin

cytarabine DRUG

Also known as: cytosine arabinoside, ara-C, arabinofuranosyl cytidine, Cytosar-U

HD ARA-C with or without Idarubicin

etoposide DRUG

Also known as: VP-16, Vepesid, Toposar, Etophosphos

HD ARA-C with or without Idarubicin

idarubicin DRUG

Also known as: Idamycin, Zavedos, 4-demethoxydaunorubicin

HD ARA-C with or without Idarubicin

autologous hematopoietic stem cell transplantation PROCEDURE

HD ARA-C with or without Idarubicin

bone marrow transplantation PROCEDURE

HD ARA-C with or without Idarubicin

peripheral blood stem cell transplantation PROCEDURE

HD ARA-C with or without Idarubicin

total-body irradiation RADIATION

HD ARA-C with or without Idarubicin

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute

Interventions

aldesleukin; Filgrastim; Busulfan; Cytarabine; Etoposide; Idarubicin; Bone Marrow Transplantation; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Radiotherapy; Investigative Techniques

Results Point of Contact

• Title: Dr. Anthony Stein
• Organization: City of Hope Medical Center

AStein@coh.org

626-5375748

Study Officials

• Anthony S. Stein, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: February 8, 2000
• Primary Completion: December 31, 2022
• Study Completion: July 16, 2025
• Last Updated: December 2, 2025
• Results First Posted: March 21, 2023

Record last verified: 2025-11