Clinical Trials

Cancer Type: Hematology


2009-316

Title: An open label phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects with Relapsed or Refractory Advanced B-Cell Malignancies.

Description: People who have leukemia, lymphoma, or multiple myeloma that has not responded to or stopped responding to treatment with standard anticancer medicines will be enrolled in this study.

Leukemias, lymphomas, and multiple myeloma are types of cancers. Some leukemias and lymphomas involve B cells. B cell is a type of white blood cell that makes antibodies, which are proteins that are also an important part of the body's immune system. . In most B-cell cancers, a protein called CD19 is expressed on the outside of the B cells.

MEDI-551 an antibody against CD19 is being studied to see if it might slow the cancer's growth or stop it from spreading to other parts of the body. For patients with B-cell cancers, such as leukemia and lymphoma, whose cancer has not slowed down or has returned after treatment with other anticancer medicines, experimental treatments such as MEDI-551 may be an option.

The purpose of this study is to test the safety of MEDI-551 when given at different doses and see what effects it has on people with certain B-cell cancers.

The study will also measure pharmacokinetics of the study drug and immune response to the study drug.

Forms:

2013-0487

Title: A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination with Idelalisib in Subjects with Relapsed or Refractory Hematologic Malignancies.

Description: This research study will evaluate the combination of two investigational drugs named GS-9973 and Idelalisib (formerly know as GS-1101) for the treatment of your cancer.

All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of lymphocytes (a type of white blood cell) gets out of control, cancers like CLL, MCL, DLBCL, FL or other iNHLs can develop. Drugs like GS 9973 and Idelalisib block some of the cell functions that cause these cancers to grow and survive and may also help control the disease
The purpose of this study is to see if GS-9973 in combination with Idelalisib can benefit patients with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe and well tolerated these study drugs are.

Both study drugs tested in this study are investigational drugs, which mean it is still being tested in people and has not been approved by the FDA.

Forms:

2013-0583

Title: A051201: A Phase I/Randomized Phase II Trial of Idelalisib and Lenolidomide in Relapsed/Refractory Mantle Cell Lymphoma

Description: The purpose of this phase 1 study is to test the safety of the combination of the drugs lenalidomide and idelalisib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on you and your lymphoma.

The purpose of the phase 2 study is to test efficacy of combination of the drugs lenalidomide and idelalisib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on you and your lymphoma.

While the Food and Drug Administration (FDA) has approved rituximab for use in this disease, the FDA has not approved lenalidomide and idelalisib for use in this disease. The use of the combination of lenalidomide, idelalisib, and rituximab is considered experimental.

Forms:

2014-0307

Title: SWOG S1304: A Phase II Randomized Study Comparing Two Doses of Carfilzomib with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease.

Description: This study is for patients with multiple myeloma that is either refractory (has not responded to prior treatment) or is relapsed (has come back after prior treatment).

All subjects enrolled on this study will receive treatment with the drugs carfilzomib and dexamethasone given through a needle into a vein (IV). The purpose of the study is to compare a higher dose of carfilzomib to the lower dose which is approved for the treatment of myeloma to find out which dose is better. Subjects will be randomly assigned (like the flip of a coin) to either the high dose or the low dose. Subjects who receive the low dose whose disease comes back or gets worse may be switched to the high dose.