Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

NCT00528398 | Completed Phase 2 Results DMC

• 5 other identifiers: 93139P30CA033572CHNMC-93139CHNMC-93139-94-03-1CDR0000564537
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

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); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); 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); secondary acute myeloid leukemia; untreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR)

  The peripheral blood neutrophil count is \>= 1.5 x 10\^9 / L and platelets more than 100 x 10\^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.

  7 days post completion of induction chemotherapy

Secondary Outcomes (1)

• Bone Marrow at Day 7 Post-Induction Chemotherapy

  7 days post completion of induction chemotherapy

Study Arms (1)

Treatment (idarubicin, cytarabine)

EXPERIMENTAL

Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Drug: cytarabine; Drug: idarubicin

Interventions

cytarabine DRUG

Also known as: Cytosine Arabinoside, Cytosar-U, Depocyt

Treatment (idarubicin, cytarabine)

idarubicin DRUG

Also known as: 4-demethoxydaunorubicin, Idamycin, Zavedos

Treatment (idarubicin, cytarabine)

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed acute myeloid leukemia (AML)
• Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
• FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
• Previously untreated with radiotherapy or chemotherapy
• Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
• Patients with prior myelodysplastic syndrome are eligible
• Extramedullary leukemia allowed
• AML with lymphoid markers allowed

You may not qualify if:

• Blastic transformation of chronic myelogenous leukemia
• Biphenotypic leukemia
• FAB M3 disease (acute promyelocytic leukemia)
• PATIENT CHARACTERISTICS:
• Life expectancy ≥ 6 weeks
• Total bilirubin \< 1.5 g/dL
• AST and ALT \< 5 times upper limit of normal (ULN)
• Creatinine \< 1.5 mg/dL OR creatinine clearance \> 70 mL/min
• Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
• HIV antibody-negative
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior hydroxyurea or corticosteroids allowed
• At least 48 hours since prior and no concurrent itraconazole or fluconazole
• More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Sponsors & Collaborators

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

Study Sites (2)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

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

Interventions

Cytarabine; Idarubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Anthony Stein, M.D.
• Organization: City of Hope National Medical Center

AStein@coh.org

626-256-4673

Study Officials

• Anthony S. Stein, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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 10, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 1994
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 6, 2017
• Results First Posted: February 6, 2017

Record last verified: 2016-12

Locations

US (2)