Category: Clinical Trials

New Clinical Trial: GS-1101 in Combination with Bendamustine and Rituximab for Previously Treated CLL

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now recruiting men and women with previously treated, recurrent chronic lymphocytic leukemia (CLL) for a clinical trial evaluating the experimental drug GS-1101 (also called Idelalisib, formerly called CAL-101), combined with bendamustine and rituximab, in treating CLL. The study sponsor is Gilead Sciences, Inc, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Age 18 and older
  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
  • Previously treated for CLL
  • Detailed eligibility reviewed when you contact the study team
Study Details

GS-1101 (CAL-101) is a pill designed to block some of the cell functions that cause CLL to grow and survive and may help control the disease. Rituximab and bendamustine are approved by the FDA as a treatment for CLL. The study will help determine whether adding GS-1101 (CAL-101) to the standard treatment of rituximab and bendamustine will have a better effect on controlling CLL.

Study participants will be randomly assigned to one of two treatment groups:

  • Group A: GS-1101 and rituximab/bendamustine
  • Group B: Rituximab/bendamustine and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

After 20 weeks of therapy with rituximab, bendamustine and GS-1101 or placebo, participants will continue with GS-1101 or placebo as long as their CLL is controlled.

Clinical Trial: MLN8237 in Relapsed/Refractory Aggressive B-Cell Lymphoma Treated With Rituximab & Vincristine

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and other aggressive lymphomas including Transformed Follicular Lymphoma, and Mantle Cell or Burkitt Lymphoma. The study sponsor is Millennium Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Jia Ruan. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Men and women age 18 and older
  • Parts 1 and 2:
    • Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma, Mantle Cell or Burkitt Lymphoma
  • Part 3:
    • Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma (people with Mantle Cell or Burkitt Lymphoma are eligible for Parts 1 and 2 only)
    • For Part 3, must have received prior rituximab
  • Relapsed or refractory after at least 1 prior systemic treatment for aggressive lymphoma; relapsed following autologous stem cell transplant is allowed
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to investigate whether the experimental drug MLN8237 has any treatment benefit when combined with rituximab (this combination is called MR) or when combined with rituximab and vincristine (called MRV). The study will also evaluate the safety and tolerability of the MR and MRV combinations.   Continue reading “Clinical Trial: MLN8237 in Relapsed/Refractory Aggressive B-Cell Lymphoma Treated With Rituximab & Vincristine”

New Clinical Trial: Rituximab,Bendamustine Hydrochloride & Bortezomib Followed by Rituximab & Lenalidomide in Older Patients with Untreated Mantle Cell Lymphoma

E1411: Intergroup Randomized Phase II Four Arm Study In Patients > 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men women age 60 and older with mantle cell lymphoma (MCL) that has not been previously treated. The study sponsor is the Eastern Cooperative Oncology Group. The principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 60 and older
  • Mantle cell lymphoma (MCL)
  • No prior therapy for MCL
  • Detailed eligibility reviewed when you contact the study team

Study Details

The study has two steps of treatment:

Step 1: The purpose of Step 1 is to determine the effectiveness of the addition of bortezomib (also called Velcade) to rituximab plus bendamustine, compared to rituximab plus bendamustine alone.

Step 2: The purpose of Step 2 is to determine the effectiveness of continuing treatment after Step 1 with lenalidomide plus rituximab, compared to continuing with rituximab alone.

Study participants will be randomly assigned to one of four treatment regimens:

  • Group 1: Step 1 rituximab plus bendamustine, followed by Step 2 rituximab for up to 2 years
  • Group 2: Step 1 bortezomib plus rituximab and bendamustine, followed by Step 2 rituximab for up to 2 years
  • Group 3: Step 1 rituximab plus bendamustine, followed by Step 2 lenalidomide plus rituximab for up to 2 years
  • Group 4: Step 1 bortezomib plus rituximab and bendamustine, followed by Step 2 lenalidomide plus rituximab for up to 2 years

Although each of the drugs used in the study are FDA-approved to treat blood cancers, the combinations used in this study have not been FDA-approved and are considered experimental.

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.

Treatment Plan

Participants will be asked to take 6 cycles (6 months) of chemotherapy in Step 1. Participants in Groups 1 and 2 will take rituximab every 8 weeks for 2 years. Participants in Groups 3 and 4 will take 24 cycles (2 years) of lenalidomide plus rituximab.