CLINICAL TRIALS


Non-Hodgkin's lymphoma
Hodgkin's disease
Chronic lymphocytic leukemia
Acute Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic and myeloproliferative disorders
Multiple Myeloma and other plasma cell disorders
Other hematologic neoplasms
Transfusion Medicine/Hemostasis
Bone Marrow Transplant - general

Phase I Studies

Link to UWCCC Clinical Trials Web page



Non-Hodgkin's lymphoma

Diffuse Large B-Cell Lymphoma

Frontline

CALGB50303: Phase III Randomized Study of R-CHOP vs. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Relapsed/Refractory

HO10407: Phase II study of Velcade and Temsirolimus for Relapsed or Refractory NHL

HO11403: A multicenter, open-label, Phase 2, safety and efficacy study of the Brutons Tyrosine Kinase (Btk) inhibitor, PCI 32765, in subjects with relapsed or refractory de novo diffuse large B-cell lymphoma

Mantle Cell Lymphoma

Frontline

No trials open at present

Relapsed/Refractory

HO09401: Phase II Study Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients with Aggressive Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

HO11402: PCYC-1104 CA: Multicenter Phase 2 Study of Bruton’s Tyrosine Kinase (Btk) Inhibitor, PCI-32765, In Relapsed Or Refractory Mantle Cell Lymphoma

Follicular Lymphoma

Frontline

E2408- A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab(BR)Followed by Rituximab vs Bortezomib-BR(BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma

Relapsed/Refractory

HO09401: Phase II Study Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients with Aggressive Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

HO09414: An Open-Label Phase III Study of Bendamustine Compared with Bendamustine + RO5072759 (GA101) In Patinets with Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

CTN0701: Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response

HL10415: A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents

Peripheral T-Cell Lymphoma

HO10405: Prospective, Longitudinal, Multinational Registry of Patients with Newly Diagnosed Peripheral T-Cell Lymphoma

Primary Central Nervious System Lymphoma

E1F05:Phase II Study of Rituximab Given in Conjunction with Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma (suspended)

Other/Multiple Types

HO 09902 (CTRC #09-1465-01): An Open Label, Dose-Escalation, Phase 1 Study of MLN9708, A Second-Generation Proteasome Inhibitor, in Adult Subjects with Lymphoma

HO09401: Phase II Study Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients with Aggressive Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

HO10411: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

HO10407: A Phase II Study of Bortezomib and Temsirolimus for Relapsed or Refractory B-cell non-Hodgkin Lymphoma

HL10415: A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents


Hodgkin's disease

SWOG0816: A Phase II Trial of Response Adapted Therapy of Stage III-lV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

CALGB 50604: Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma



Chronic lymphocytic leukemia

Frontline

CALGB10404: A Randomized Phase II Study of Three Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

E1908: A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab and Rituximab

HO11401: An Open-Label, Multicenter, Phase Ib Trial of GA101 in Combination with Chemotherapy in Patients with Previously Untreated Chronic Lymphocytic Leukemia

Relapsed/Refractory

HO08405: Phase II Trial of Bendamustine and Rituxan Induction followed by Revlimid Maintenance for Relapsed/Refractory CLL/SLL

HO10411: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia



Acute Leukemia

AML

CALGB 10603: A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML) (Note: Patients must also consent to the E3903 leukemia marrow collection protocol)

CO10906: Phase 1 Study of LY573636-sodium in Patients with Relapsed or Refractory Acute Myeloid Leukemia

E1905: A Randomized Phase II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leukemia with Multilineage Dysplasia (open for patients with treatment-related MDS/AML only)

CO08901- A Phase I Dose Escalation Study of Oral SB939 when administered Thrice Weekly (every other day) for 3 weeks in a 4-week cycle in Patients with Advanced Malignancies (relapsed/refractory disease only)

CO08914: Phase I Study of PXD101 in Combination with 5-Azacitidine (5-Aza) for Advanced Hematologic Malignancies (relapsed/refractory, elderly, or treatment-related disease - must have dysplasia)

BMTCTN0502: A Phase II Study of Allogeneic Transplant for Older Patients with AML in First Morphologic Complete Remission using a Non-Myeloablative Preparative Regimen

E2906: Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥ 60 Years)

ALL

E1904: A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase, and Dexamethasone) with Subcutaneous Campath for Adults with Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)

AALL0232

AALL0434



Chronic Myelogenous Leukemia

No trials open at present



Myelodysplastic and myeloproliferative disorders

E1905: A Randomized Phase II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leukemia with Multilineage Dysplasia (open for patients with treatment-related MDS/AML only)

E2905: Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia (suspended)

MC048H: A Phase II Study of AZD2171 in Acute Myeloid Leukemia and Myelodysplastic Syndrome (open for MDS patients only)

CO 08914: Phase I Study of PXD101 in Combination with 5-Azacitidine (5-Aza) for Advanced Hematologic Malignancies

CO08901- A Phase I Dose Escalation Study of Oral SB939 when administered Thrice Weekly (every other day) for 3 weeks in a 4-week cycle in Patients with Advanced Malignancies



Multiple Myeloma and other plasma cell disorders

Multiple Myeloma

Frontline

E1A06: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-dose Therapy

S0777 (SWOG): A Randomized Phase III Trial of Lenalidomide and Low Dose Dexamethasone (LLD) Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Relapsed/Refractory

HO10408: A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation

HO06401:  Phase II Trial of Bevacizumab Combined with Lenalidomide and Dexamethasone  (BEV/REV/DEX) in Relapsed or Refractory Multiple Myeloma

E3A05: Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients considered for Studies of Plasma Cell Disorders

HO07403: A Longitudinal Study to Evaluate Changes in Cellular Protein Expression and Activation in Bone Marrow Tumor Cells and Stromal Cells from Patients with Multiple Myeloma

CO08901- A Phase I Dose Escalation Study of Oral SB939 when administered Thrice Weekly (every other day) for 3 weeks in a 4-week cycle in Patients with Advanced Malignancies

MC0888: A Phase II Trial of cdk Inhibitor SCH727965 in Multiple Myeloma (suspended)

E2A08: Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients with Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant

Waldenstrom Macroglobulinemia

HO09401: Phase II Study Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients with Aggressive Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

HL10415: A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents



Other hematologic neoplasms

No trials open at present



Transfusion medicine/Hemostasis

HO08401: High dose granulocyte transfusion for the treatment of infection in neutropenia. The RING study (Resolving Infection in Neutropenia with Granulocytopenia) Detailed eligibility criteria Full protocol Consent form

ITP2: A Randomized Trial Comparing the Long Term Efficacy of Standard Oral Corticosteroid Therapy with Prednisone Versus 3 Courses of High Dose Dex. in Patients with newly-diagnosed ITP



Bone Marrow Transplant

HO08402 (DCB-05): A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults with Hematologic Malignancy (Link to full protocol)
  

BMTCTN0502: A Phase II Study of Allogeneic Transplant for Older Patients with AML in First Morphologic Complete Remission using a Non-Myeloablative Preparative Regimen

BMTCTN0801: Phase II/III Randomized, Mulitcenter Trial Comparting Sirolimus plus Prednisone, Sirolimus/Extracorporeal Photopheresis plus Prednisone, and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease

HO10414: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)


Phase I studies

CO08901- A Phase I Dose Escalation Study of Oral SB939 when administered Thrice Weekly (every other day) for 3 weeks in a 4-week cycle in Patients with Advanced Malignancies

CO08914: Phase I Study of PXD101 in Combination with 5-Azacitidine (5-Aza) for Advanced Hematologic Malignancies

HO 09902 (CTRC #09-1465-01): An Open Label, Dose-Escalation, Phase 1 Study of MLN9708, A Second-Generation Proteasome Inhibitor, in Adult Subjects with Lymphoma

CO10906: Phase 1 Study of LY573636-sodium in Patients with Relapsed or Refractory Acute Myeloid Leukemia

CO 08907: Phase I study of topotecan & carboplatin for relapsed/refractory AML, ALL or high risk MDS, including primary induction failure. Patients with aggressive phase MPD and CML also eligible. Call Phase I office (3-6222) for more information

CO 10902: Phase I study of an oral HDAC inhibitor. Call Phase I office (3-6222) for more information

Revised Oct 2010