Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia

NCT00258271 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000448638URCC-U26403URCC-RSRB-10427NOVARTIS-CSTI571AUS161
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult acute megakaryoblastic leukemia (M7); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia without maturation (M1); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); blastic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia

Interventions

filgrastim BIOLOGICAL

cladribine DRUG

cytarabine DRUG

imatinib mesylate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) or blastic phase chronic myelogenous leukemia (CML) * Refractory AML defined as any of the following: * Failure to achieve complete response (CR) after 2 courses of induction chemotherapy * Persistent bone marrow blasts \> 40% after 1 course of induction chemotherapy * Relapse of disease within 3 months since CR * Relapsed AML defined as the following: * Any evidence of disease recurrence after CR (early relapse occurs within 3-12 months and late relapse occurs \> 12 months later) * No acute promyelocytic leukemia (AML-M3 FAB subgroup) PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL * AST ≤ 2.5 times upper limit of normal * No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal * Creatinine \< 2.5 mg/dL (if 2.0-2.5 mg/dL, glomerular filtration rate must be measured and dose of cytarabine adjusted if necessary) Cardiovascular * No New York Heart Association grade III-IV heart disease * No congestive heart failure * No myocardial infarction within the past 6 months * Ejection fraction ≥ 30% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment * No uncontrolled systemic active infection * No known HIV infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No history of other curatively treated malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent biologic agents Chemotherapy * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy * No concurrent birth control pills Other * More than 1 week since any prior investigational agent * No other concurrent investigational agents or therapies * No other concurrent anticancer agents * No concurrent therapeutic anticoagulation with warfarin * Low molecular weight heparin or heparin allowed for therapeutic anticoagulation * Mini-dose warfarin (e.g., 1 mg per day) allowed for prophylaxis of central venous catheter thrombosis

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Walker AR, Komrokji RS, Ifthikharuddin J, Messina P, Mulford D, Becker M, Friedberg J, Oliva J, Phillips G, Liesveld JL, Abboud C. Phase I study of cladribine, cytarabine (Ara-C), granulocyte colony stimulating factor (G-CSF) (CLAG Regimen) and simultaneous escalating doses of imatinib mesylate (Gleevec) in relapsed/refractory AML. Leuk Res. 2008 Dec;32(12):1830-6. doi: 10.1016/j.leukres.2008.04.026. Epub 2008 Jun 20.

  PMID: 18571721 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Blast Crisis

Interventions

Filgrastim; Cladribine; Cytarabine; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Study Officials

• Camille Abboud, MD

  James P. Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: March 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)