Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00814164 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000630678RPCI-I-132208
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.

Conditions

Leukemia

Keywords

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); untreated adult acute myeloid leukemia; 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

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR)

  Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of \< 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease \[imaging required only if obtained pretreatment for known site(s) of disease\]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).

  2 years

Secondary Outcomes (7)

• Disease-free Survival

  5 years

• Overall Survival

  4 years

• Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy

  4 years

• Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes

  4 years

• Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression

  4 years

Study Arms (1)

Clorafarbine with daunorubicin

EXPERIMENTAL

Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.

Drug: clofarabine; Drug: daunorubicin hydrochloride; Genetic: cytogenetic analysis; Genetic: protein expression analysis; Other: immunologic technique; Other: pharmacological study

Interventions

clofarabine DRUG

IV

Clorafarbine with daunorubicin

daunorubicin hydrochloride DRUG

IV

Clorafarbine with daunorubicin

cytogenetic analysis GENETIC

Correlative study

Clorafarbine with daunorubicin

protein expression analysis GENETIC

Correlative Study

Clorafarbine with daunorubicin

immunologic technique OTHER

Correlative Study

Clorafarbine with daunorubicin

pharmacological study OTHER

Correlative Study

Clorafarbine with daunorubicin

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia * At least 10% blasts in the peripheral blood * De novo or secondary disease * No acute promyelocytic leukemia with t\[15;17\] or any other variant * No clinical evidence of CNS disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * LVEF ≥ 45% * Estimated glomerular filtration rate ≥ 50 mL/min * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment * No known HIV positivity * Able to comply with study procedures and follow-up examinations * No psychiatric disorders that would interfere with consent, study participation, or follow-up * No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment) * No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents * No other malignancy, unless disease-free for at least 3 years following curative intent therapy * Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed if definitive treatment for the condition has been completed * Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed * No other severe concurrent disease PRIOR CONCURRENT THERAPY: * No other concurrent systemic antileukemic therapy (standard or investigational) * No concurrent cytotoxic therapy or investigational therapy * No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes) * No prior chemotherapy * Prior hydroxyurea allowed

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

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

Interventions

Clofarabine; Daunorubicin; Cytogenetic Analysis; Immunologic Techniques

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)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Meir Wetzler, MD

  Roswell Park Cancer Institute

  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: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 17, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-07

Locations

US (1)