<strong>Hematologic</strong> <strong>Malignancies</strong>Leukemia, Lymphoma, Myelomaand Stem Cell TransplantationClinical TrialsTo learn more about the clinical studies, or to enroll a patient,please contact the listed study coordinator at 314-454-8377.AML, newly diagnosedAcute Leukemia /MDSCALGB 10503 PI: Ravi Vij Study Coordinator:Ryan MonahanPhase II Study of Maintenance Therapy With DecitabineFollowing Standard Induction and Cytogenetic Risk-AdaptedIntensification in Previously Untreated Patients With AML< 60 Years.Notes: Newly dx de novo AML age 18-59, randomized to decitabinemaintenance after induction and risk adapted consolidation basedon cytogenetics to either HiDAC or auto transplant08-0126 PI: Ravi Vij Study Coordinator:Ryan MonahanSWOG S0521— A Randomized Trial of Maintenance VersusObservation for Patients with Previously Untreated Low andIntermediate Risk Acute Promyelocytic Leukemia (APL),Phase III.Notes: Low or intermediate risk APL 18 years and older withno prior systemic therapy or recurrent disease.06-0907 PI: Ravi Vij Study Coordinator:Alissa NelsonPhase II Trial of Lenalidomide in Older Patients (> 60 years)with Untreated Acute Myeloid Leukemia without Chromosome5q AbnormalitiesAML, relapsed refractory07-0227 PI: Geoffrey Uy Study Coordinator:Sandra LopezA Phase I/II Study of AMD3100 With Mitoxantrone, Etoposide andCytarabine (AMD3100+MEC) in Relapsed or Refractory AML.Notes: Age 18-65 with either primary refractory AML, relapsed AMLwith initial CR less than 1 yr or in 2nd relapse or higher08-0017 PI: Keith Stockerl-GoldsteinStudy Coordinator:Alissa NelsonOpen Label Randomized Controlled Dose Escalating Phase IIStudy of AS1411 Combined with Cytarabine in the Treatmentof Patients with Primary Refractory or Relapsed Acute MyeloidLeukemia (AS1411-C-201).Notes: Refractory or relapsed AML and 18 years of age or older.MDS/AML, otherP2C 05-1159PI: Amanda CashenPhase II Study of the Histone Deacetylase Inhibitor PXD101for the Treatment of Myelodysplastic SyndromeNotes: 18 years old and up with a diagnosis of MDS, no morethan 2 previous lines of therapy and either ineligible or refusedallo transplant.08-0172 PI: Geoffrey Uy Study Coordinator:Alissa NelsonA Phase I/II Study of LBH589 plus Decitabine for PatientsAge > 60 Years with High Risk MDS or AMLNotes: Age > 60 with MDS (IPSS>2) or AML with no prior treatmentwith a hypomethylating agentCALGB 100103 PI: Ravi Vij Study Coordinator:Ryan MonahanA Phase II Study Of Allogeneic Transplant For Older PatientsWith AML In First Morphologic Complete Remission UsingA Non-Myeloablative Preparative Regimen.Notes: CR1, Fludarabine, Busulfan, Thymoglobulin conditioning07-0643 PI: John DiPersio Study Coordinator:Jeremy GabrielA Phase II Study of Active Immunotherapy With GRNVAC1,Autologous Mature Dendritic Cells Transfected With mRNAEncoding Human Telomerase Reverse Transcriptase, inPatients With Acute Myelogenous Leukemia in CompleteClinical Remission.Notes: Age 18-65 with AML in 1st or 2nd CR using dendriticcell vaccine directed against telomerase (hTERT)08-X139 PI:Camille Abboud Study Coordinator:Ryan MonahanPhase I Study of Oral Clofarabine Consolidation in Adults Aged60 and Older with Acute Myeloid LeukemiaStudy Coordinator:07-0916 PI: Ravi VijLiz ProcknowA Phase II study of intravenous Decitabine in combinationwith Arsenic Trioxide and Ascorbic Acid in patients withmyelodysplastic syndromesNotes: MDS defined by FAB classification.ALLCALGB 10403 PI: Ravi Vij Study Coordinator:Ryan MonahanAn Intergroup Phase II Clinical Trial for Adolescents and Youngadults with Untreated Acute Lymphoblastic Leukemia.Notes: Newly diagnosed and untreated ALL between the age of16 and 29.4
<strong>Hematologic</strong>al <strong>Malignancies</strong> is published by The Alvin J. <strong>Siteman</strong> <strong>Cancer</strong> <strong>Center</strong> at Barnes-Jewish Hospital and Washington UniversitySchool of Medicine. The <strong>Siteman</strong> <strong>Cancer</strong> <strong>Center</strong> is a Comprehensive <strong>Cancer</strong> <strong>Center</strong> designation from the National <strong>Cancer</strong> Institute (NCI) andmembership in the National Comprehensive <strong>Cancer</strong> Network (NCCN).Editors: Geoffrey Uy, M.D. and Ryan Monahan | Article Contributors: Nancy Bartlett, M.D. and Nina Wagner-Johnston, M.D. |Production Manager: Angela BenassiFollicularNON-HODGKIN LYMPHOMA (NHL)CALGB 50401 PI: Nancy L.BartlettStudy Coordinator:Rachael KeeleyA Randomized Phase II trial of Rituximab vs. Lenalidomide(Revlimid TM , CC-5013) (IND # 73034) vs. Rituximab + Lenalidomidein Recurrent Follicular Non-Hodgkin Lymphoma (NHL) ThatIs Not Rituximab-Refractory (Arm A, Rituximab Alone, waspermanently closed effective 9/15/2007)Notes: Patients must have been treated with rituximab either aloneor in combination with chemotherapy. The last prior treatmentregimen need not include rituximab but must have progressed>6 months from their last rituximab dose.CALGB 50701 PI: Nancy L.BartlettStudy Coordinator:Justina FirstA Phase II Trial of Extended Induction Epratuzumab (Anti-CD22Monoclonal Antibody) Plus Rituximab in Previously UntreatedFollicular Non-Hodgkin’s Lymphoma07-0889 PI: Nancy L.BartlettStudy Coordinator:Rachael KeeleyA Phase II, Single-Arm, Open-Label Study of the Safety,Pharmacokinetics, and Efficacy of Multiple Doses of APOMABAdministered Intravenously in Combination with Rituximab inPatients with Follicular, CD20-positive B-cell non-Hodgkin’sLymphoma that has Progressed Following Previous Rituximab TherapyNotes: Patients must have had a complete response, partialresponse, or stable disease lasting more than 6 months aftercompletion of their most recent rituximab-containing regimen.08-0332 PI: Amanda Cashen Study Coordinator:Rachael KeeleyA Phase II Study of Bortezomib in Combination withBendamustine and Rituximab in Subjects with Relapsed orRefractory Follicular LymphomaNotes: Prior treatment with Bortezomib or Bendamustine is notallowed; at least 4 prior doses of Rituximab; prior allogeneic stemcell transplant not allowed.Large CellCALGB 50303 PI: Nancy L.BartlettStudy Coordinator:Sarah LarsonPhase III Randomized Study of R-CHOP vs. Dose-AdjustedEPOCH-R with Molecular Profiling in Untreated De Novo DiffuseLarge B-Cell LymphomasNotes: Patients must have a new biopsy if fresh/frozen tissue wasnot available from their first biopsy, unless contraindicated.07-1073 PI: Nancy L.BartlettStudy Coordinator:Justina FirstA Randomized Phase IIb Placebo-Controlled Study of R-ICEChemotherapy (Rituximab, Ifosfamide, Carboplatin, andEtoposide) with and without SGN-40 (Anti-CD40 humanizedmonoclonal antibody) for Second-line Treatment of Patients withDiffuse Large B-Cell LymphomaNotes: Patients must have achieved a complete response, partialresponse, or stable disease from their most recent prior therapyconsisting of combination chemotherapy and rituximab.07-0927 PI: Nancy L.BartlettStudy Coordinator:Rachael KeeleyA Phase II Multicenter, Open-Label Study of YM155 in RefractoryDiffuse Large B-Cell Lymphoma (DLBCL) SubjectsNotes: Patients must have been refractory to the lasttreatment regimen.08-0500 PI: Nancy L.BartlettStudy Coordinator:Sarah LarsonA Phase Ib Study of SGN-40 in Combination with Rituximab andGemcitabine for the Treatment of Patients with Relapsed orRefractory Diffuse Large B-Cell LymphomaMantle CellCALGB 50403 PI: Nancy L.BartlettStudy Coordinator:Rachael KeeleyA Randomized Phase II Trial of Maintenance vs. ConsolidationBortezomib Therapy Following Aggressive Chemo-Immunotherapyand Autologous Stem Cell Transplant for Previously UntreatedMantle Cell LymphomaNotes: Patients must be between the ages of 18 and 69 years withany stage (I-IV).CALGB 50501 PI: Nancy L.BartlettStudy Coordinator:Donna SeckfortA Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide(Revlimid TM , CC-5013) (NSC#703813) For Relapsed/RefractoryMantle Cell LymphomaNotes: Patients may not have received prior bortezomib orlenalidomide therapy.AIDS/HTLVAMC 047 PI: Lee Ratner Study Coordinator:Lee RatnerA Phase II Trial of Doxil, Rituximab, Cyclophosphamide,Vincristine, and Prednisone (DR-COP) in Patients with NewlyDiagnosed AIDS-Associated B-Cell Non-Hodgkin’s LymphomaAMC 048 PI: Lee Ratner Study Coordinator:Lee RatnerProspective Phase II Study of a High Dose, Short CourseRegimen (R-CODOX-M/IVAC) Including Central Nervous System(CNS) Penetration and Intensive Intrathecal (IT) Prophylaxis inHIV-Associated Burkitt’s and Atypical Burkitt’s Lymphoma.(continued on page 6)5