Leridistim Compared With Filgrastim in Treating Older Patients With Acute Myeloid Leukemia

NCT00004215 | Completed Phase 2

• 5 other identifiers: 99-055CDR0000067436MCC-11506SC-IN5-99-12-011NCI-G99-1652
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as leridistim and filgrastim increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of leridistim with that of filgrastim to reduce side effects in older patients who are receiving cytarabine and daunorubicin for acute myeloid leukemia.

Conditions

Anemia; Leukemia; Neutropenia; Thrombocytopenia

Keywords

untreated adult acute myeloid leukemia; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); adult acute monocytic leukemia (M5b); anemia; neutropenia; thrombocytopenia; adult acute minimally differentiated myeloid leukemia (M0)

Interventions

filgrastim BIOLOGICAL

leridistim BIOLOGICAL

cytarabine DRUG

daunorubicin hydrochloride DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Induction phase: Cytologically proven de novo acute myeloid leukemia (not M3) Eligible to receive cytarabine and daunorubicin Circulating blast count no greater than 75,000/mL (hydroxyurea or leukapheresis allowed to decrease blast count) No blast transformation of chronic myelogenous leukemia No myelodysplastic syndrome or antecedent hematologic disorder longer than 6 months Post Induction Phase: Severe bone marrow aplasia (less than 5% blasts and less than 10% cellularity) No persistent leukemia after 2 induction courses PATIENT CHARACTERISTICS: Age: 55 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No significant cardiac disease No cardiac arrhythmia No uncontrolled hypertension No recent myocardial infarction or ischemia Other: No uncontrolled metabolic condition that would preclude study No psychiatric condition that would preclude study HIV negative Hepatitis B surface antigen negative No known hypersensitivity to corticosteroids, E. coli protein, interleukin-3, SC-55494, SC-68420, leridistim, milodistim, or filgrastim (G-CSF) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-3, milodistim, SC-55494, SC-68420, or leridistim No prior peripheral blood stem cell or bone marrow transplantation No concurrent epoetin alfa or interleukin-11 Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: At least 2 weeks since prior surgery (except catheter placement or biopsy) Other: At least 3 weeks since prior investigational drug No other concurrent investigational drug

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Anemia; Leukemia; Neutropenia; Thrombocytopenia; Leukemia, Erythroblastic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Filgrastim; leridistim; Cytarabine; Daunorubicin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Blood Platelet Disorders; 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; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides

Study Officials

• Mark Lawrence Heaney, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: August 9, 2004
• Study Start: August 1, 1999
• Primary Completion: August 1, 2000
• Study Completion: August 1, 2000
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)