Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate

NCT00038675 | Completed Results DMC

• 1 other identifier: ID01-167
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate (STI571), can improve the disease condition in patients with hypereosinophilic syndrome, polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.

Conditions

Chronic Myelomonocytic Leukemia; Chronic Myeloid Leukemia; Polycythemia Vera; Hypereosinophilic Syndrome; Mastocytosis

Keywords

Leukemia; Chronic Myelomonocytic Leukemia; Chronic Myeloid Leukemia; Polycythemia Vera; Hypereosinophilic Syndrome; Mastocytosis; Imatinib Mesylate; Gleevec

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Complete Response (CR)

  Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood \& bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, \& platelet count \>100 x 10\^9/L; or CR marrow=As per CR but platelet count \< 100 x 10\^9/L. Agnogenic myeloid metaplasia (AMM) \& CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10\^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (\< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\</=10%), disappearance signs/symptoms of disease. Mastocytosis: CR=disappearance of mast cell infiltrates in affected organs, decrease of serum tyrptase levels to \<20 ng/ml, \& disappearance of SM-associated organomegaly.

  after 2 months of therapy, up to 1 year.

Secondary Outcomes (2)

• Duration of Response

  From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months

• Overall Survival

  From the start of therapy to death or disease progression, assessed up to 12 years and 5 months

Study Arms (1)

Imatinib

EXPERIMENTAL

Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily.

Drug: Imatinib Mesylate (Gleevec)

Interventions

Imatinib Mesylate (Gleevec) DRUG

Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily

Also known as: Gleevec

Imatinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have 1 of the following hematopoietic malignancies: Hypereosinophilic syndrome (HES), Polycythemia vera (PV), Atypical CML or CMML with PDGF-R fusion genes, Mastocytosis, Serum bilirubin less than 2 mg%, serum creatinine less than 2 mg% unless abnormality is considered due to hematologic malignancy by investigator, Eastern Cooperative Oncology Group (ECOG) performance status \< 3, life expectancy \> 12 wks,

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Polycythemia Vera; Hypereosinophilic Syndrome; Mastocytosis; Leukemia

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myeloproliferative Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Eosinophilia; Leukocyte Disorders; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Hagop M Kantarjian,MD/Chair, Leukemia
• Organization: University of Texas (UT) MD Anderson Cancer Center

hkantarjian@mdanderson.org

(713) 792-7026

Study Officials

• Jorge Cortes, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2002
• First Posted: June 5, 2002
• Study Start: June 1, 2001
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 4, 2022
• Results First Posted: January 4, 2022

Record last verified: 2021-12

Locations

US (1)