Selected Clinical Trials in Leukemia and Myelodysplastic Syndromes

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Clinical Leukemia December 2007 Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1931-6925, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400. Clinical Trials Trial Phase Sponsor Contact Information Selected Clinical Trials in Leukemia and Myelodysplastic Syndromes Chronic Myeloid Leukemia A Phase II Open Label Study of the I.V. Administration of Homoharringtonine Combined with the Oral Administration of Gleevec in the Treatment of Patients with CML in Chronic, Accelerated and Blast Phase Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with T315I BCR-ABL Gene Mutation Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) with Dasatinib (BMS-354825) Acute Myeloid Leukemia Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML) Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence with Standard Chemotherapy to Patients with Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations A Phase II Study of Iressa (Gefitinib), in Patients with Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients with Newly Diagnosed Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Randomized Phase 3 Trial of Decitabine Versus Patient's Choice with Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed Acute Myeloid Leukemia Chronic Lymphocytic Leukemia A Phase II Study of Lenalidomide as Initial Treatment of Patients with Chronic Lymphocytic Leukemia Age 65 or Older - RV-CLL-PI-0188 A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) A Phase II Study of CCI-779 in B-Cell Lymphoma and Chronic Lymphocytic Leukemia (CLL) Myelodysplastic Syndrome A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS) A Phase II Study of and Oral Histone Deacytylase Inhibitor, MS-275 (NSC 706995), in Combination with Sargramostim (GM-CSF, Berlex, Inc.) Treating Relapsed and Refractory Myeloid Malignancies Dennis M. Brown, PhD; 650-474-9800 Ext 108; [email protected] Dennis M. Brown, PhD; 650-474-9800 Ext 108; [email protected] Jorge Cortés, MD; 713-794-5783 Shirley Leow; 617-225-0522 Ext 135; [email protected] Bill Lundberg, MD; 617-225-0522 Ext 164; [email protected] Farhad Ravandi-Kashani, MD; 713-745-0394 Miloslav Beran, MD; 713-792-2248; [email protected] Daniel J. DeAngelo, MD, PhD; 617-632-2645; [email protected] Medical Communications; 800-562-5580 Ext 1 Alessandra Ferrajoli, MD; 713-792-2063 Tracy Dufresne; 210-593-5265 Barbara Pro, MD; 713-792-2860 Pankaj Gupta, MD; 612-467-2800 Recruiting Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center; 410-955-8804; [email protected] ChemGenex Pharmaceuticals ChemGenex Pharmaceuticals University of Texas M. D. Anderson Cancer Center (MDACC) Bristol-Myers Squibb Xanthus Pharmaceuticals, Inc MDACC Cephalon Dana-Farber Cancer Institute Brigham and Women's Hospital Children's Hospital Boston MGI Pharma MDACC Celgene Corporation Cylene Pharmaceuticals MDACC National Cancer Institute (NCI) Cancer and Leukemia Group B NCI Sidney Kimmel Comprehensive Cancer Center NCI II II II III II II II II II II II II II 363

Transcript of Selected Clinical Trials in Leukemia and Myelodysplastic Syndromes

Clinical Leukemia • December 2007

Electronic forwarding or copying is a violation of US and International Copyright Laws.Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP,ISSN #1931-6925, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400.

Clinical Trials

Trial Phase Sponsor Contact Information

Selected Clinical Trials in Leukemia and Myelodysplastic Syndromes

Chronic Myeloid Leukemia

A Phase II Open Label Study of the I.V. Administration of Homoharringtonine Combined with the Oral Administration of Gleevec in the Treatment of Patients with CML in Chronic, Accelerated and Blast Phase

Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with T315I BCR-ABL Gene Mutation

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) with Dasatinib (BMS-354825)

Acute Myeloid Leukemia

Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)

Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence with Standard Chemotherapy to Patients with Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

A Phase II Study of Iressa (Gefitinib), in Patients with Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients with Newly Diagnosed Acute Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Randomized Phase 3 Trial of Decitabine Versus Patient's Choice with Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Chronic Lymphocytic Leukemia

A Phase II Study of Lenalidomide as Initial Treatment of Patients with Chronic Lymphocytic Leukemia Age 65 or Older - RV-CLL-PI-0188

A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

A Phase II Study of CCI-779 in B-Cell Lymphoma and Chronic Lymphocytic Leukemia (CLL)

Myelodysplastic Syndrome

A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS)

A Phase II Study of and Oral Histone Deacytylase Inhibitor, MS-275 (NSC 706995), in Combination with Sargramostim (GM-CSF, Berlex, Inc.) Treating Relapsed and Refractory Myeloid Malignancies

Dennis M. Brown, PhD; 650-474-9800 Ext 108;

[email protected]

Dennis M. Brown, PhD; 650-474-9800 Ext 108;

[email protected]

Jorge Cortés, MD; 713-794-5783

Shirley Leow; 617-225-0522 Ext 135;

[email protected] Lundberg, MD;

617-225-0522 Ext 164; [email protected]

Farhad Ravandi-Kashani, MD; 713-745-0394

Miloslav Beran, MD; 713-792-2248;

[email protected]

Daniel J. DeAngelo, MD, PhD; 617-632-2645;

[email protected]

Medical Communications; 800-562-5580 Ext 1

Alessandra Ferrajoli, MD; 713-792-2063

Tracy Dufresne; 210-593-5265

Barbara Pro, MD; 713-792-2860

Pankaj Gupta, MD; 612-467-2800

Recruiting Clinical Trials Office - Sidney Kimmel

Comprehensive Cancer Center; 410-955-8804;

[email protected]

ChemGenex Pharmaceuticals

ChemGenex Pharmaceuticals

University of Texas M. D. Anderson Cancer Center (MDACC)

Bristol-Myers Squibb

Xanthus Pharmaceuticals, Inc

MDACC

Cephalon

Dana-Farber Cancer InstituteBrigham and Women's Hospital

Children's Hospital Boston

MGI Pharma

MDACCCelgene Corporation

Cylene Pharmaceuticals

MDACCNational Cancer Institute (NCI)

Cancer and Leukemia Group BNCI

Sidney Kimmel Comprehensive Cancer Center

NCI

II

II

II

III

II

II

II

II

II

II

II

II

II

363