Two Newly Opened Clinical Trials Evaluate Idelalisib in Indolent non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened two clinical trials evaluating the experimental drug idelalisib in previously treated indolent non-Hodgkin lymphomas (iNHL). The sponsor of the trials is Gilead Sciences.  The principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the studies please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Idelalisib (GS-1101, previously CAL-101) works by blocking some of the cell functions that cause iNHL to grow and survive.

Gilead 0124: Idelalisib in Combination With Rituximab 

This study evaluates the effectiveness of idelalisib combined with rituximab in treating iNHL. Rituximab is FDA-approved for treating iNHL. It is possible that giving rituximab together with idelalisib may have more activity against iNHL than giving rituximab alone.

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma (iNHL)
  • Have received prior therapy containing anti-CD20 antibody
  • iNHL is not refractory to rituximab

Click here for a detailed summary of this trial.

Gilead 0125: Idelalisib in Combination With Bendamustine and Rituximab

This study evaluates the effectiveness of idelalisib combined with bendamustine and rituximab. Rituximab and bendamustine are FDA-approved for treating iNHL. It is possible that giving rituximab and bendamustine together with idelalisib is more effective in treating iNHL than giving rituximab and bendamustine alone.

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma
  • Have received prior therapy containing anti-CD20 antibody and chemotherapy
  • iNHL is not refractory to bendamustine

Click here for a detailed summary of this trial.


Weill Cornell’s Dr. John Leonard Named Chair of NCI’s Alliance for Clinical Trials in Oncology Lymphoma Committee

Weill Cornell’s Dr. John Leonard has been named chair of the Lymphoma Committee for the prestigious Alliance for Clinical Trials in Oncology, sponsored by the National Cancer Institute (NCI).

John Leonard, MD

John Leonard, MD

Dr. Leonard is the Associate Dean for Clinical Research at Weill Cornell Medical College, the director of the Joint Clinical Trials Office at NewYork-Presbyterian Hospital/Weill Cornell Medical College, and the clinical director of the Weill Cornell Lymphoma Program. An internationally-recognized hematology and oncology expert specializing in the treatment of lymphoma, Dr. Leonard has been a pioneer in the development of novel lymphoma therapeutics. .

In his role as chair of the NCI-sponsored Lymphoma Committee, Dr. Leonard will help guide the national agenda for lymphoma research by developing, supporting and shepherding Phase II and Phase III clinical trials funded by NCI at medical centers around the United States. Dr. Leonard will direct a team of lymphoma clinical and laboratory researchers from academic and community medical centers across the country to create and implement new standards of treatment as well as foster the development of novel therapeutics.

“I am honored and deeply humbled to be chosen to lead this vital national effort to improve cancer care for patients in the United States,” said Dr. Leonard. “This appointment, I believe, is a true reflection of the programs and major accomplishments we’ve made here at Weill Cornell in advancing lymphoma research and clinical care. We are recognized as a leading center internationally in contributing new approaches to lymphoma management, and I am excited to continue collaborating with colleagues both here and across the country to move the field forward and improve the effectiveness of therapies that are available for patients.”


New clinical trial: Ibrutinib in Refractory Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened a clinical trial evaluating ibrutinib in men and women with refractory follicular lymphoma. The study sponsor is Janssen Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Age 18 and older
  • Refractory follicular lymphoma
  • Previously treated with at least 2 prior lines of therapy
  • Did not respond to last prior therapy
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to evaluate the response to treatment with the experimental drug ibrutinib, also called PCI-32765. Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive.

Treatment Plan

All study participants will receive ibrutinib; there is no placebo. Participants will take 4 capsules by mouth once every day. Participants will continue taking ibrutinib as long as they are responding to treatment and not experiencing unacceptable side effects.

Click here to view all current lymphoma trials at Weill Cornell Medical College.


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

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

This study is ongoing, but not recruiting participants.

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.   Read the rest of this entry »


Weill Cornell’s Dr. John Leonard One of “Top 8 Leaders” in Westchester Magazine

John Leonard, MD, the Director of the Weill Cornell Lymphoma Program, is featured in Westchester Magazine’s “Top 8 Leaders in Westchester County in 2013.”

Dr. Leonard is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology and Associate Dean for Clinical Research, Weill Cornell Medical College.

Click the image below to read the article.

Westchester Magazine


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.


NewYork-Presbyterian ‘Light the Night Walk’ Team for LLS

NewYork-Presbyterian is forming a team for Light The Night Walk. Light The Night Walk is The Leukemia & Lymphoma Society’s evening walk and fundraising event. It is the nation’s night to pay tribute and bring hope to thousands of people battling blood cancers and to commemorate loved ones lost. By joining our team and raising funds for this important cause, you’ll be making a real impact on the fight against cancer. Patients, friends and family are welcome to join the NewYork-Presbyterian team.

Light the Night Walk

Wednesday, October 3, 2012
5:30pm NYP Team Photo
6:15pm Remembrance Ceremony

Basketball City
Pier 36, 299 South Street, New York, NY
(Look for RED NYP Team T-Shirts)

Click here to join the NYP Light the Night Team

NYP team t-shirts will be available starting Monday, September 10.
In order to pick up your T-shirt, you must printand bring a copyof your email registration to one of the following locations:

NewYork-Presbyterian/Columbia Campus
Public Affairs Office, 627 West 165th Street, 6th floor, Room 621
Contact:Nancy Gautier-Matos @ 212-305-5587 or gautier@nyp.org

NewYork-Presbyterian/Weill Cornell Campus
1300 York Avenue (at 69th Street), 2nd floor, Room F-203
Contact:Christine Dillon @ 212-746-2057 or chw9040@nyp.org

For  additional information, please call
Christine Dillon @ 212-746-2057 or chw9040@nyp.org


New Clinical Trial: GS-1101 (CAL-101) + Rituximab for Previously Treated CLL

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL 101) in Combination with Rituximab for Patients with Previously Treated Chronic Lymphocytic Leukemia

The Weill Cornell Lymphoma Program is now enrolling patients in a new clinical trial for people with previously treated Chronic Lymphocytic Leukemia (CLL). The sponsor is Gilead Sciences, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Study Details

The study will evaluate the effectiveness of the experimental drug GS-1101 (CAL-101) combined with rituximab in treating CLL.

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 is FDA-approved as a treatment for CLL. It is possible that giving rituximab together with GS-1101 may have more activity against the CLL disease process than giving rituximab alone.

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

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

Treatment Plan

All study participants will receive rituximab via infusion 8 times over 24 weeks: Day 1, then Weeks 2, 4, 6, 8, 12, 16 and 20.

Participants will take GS-1101 or placebo twice daily for 24 weeks.

After 24 weeks of therapy with rituximab and GS-1101 or placebo, participants will continue on GS-1101 or placebo as long as their CLL is controlled. If their CLL gets worse, participants may be able to take part in a separate extension study where they receive GS-1101 at a higher or lower dose. Thus, everyone who is treated in this study has an opportunity to receive active GS-1101, either in the main study or the extension study.


 

 


Dr. John Leonard Discusses Antibody Therapy in Lymphoma

Weill Cornell’s Dr. John Leonard discusses antibody therapy in lymphoma in a Medscape CME program. Click here to view the presentation.

 

 

 


Follow

Get every new post delivered to your Inbox.

Join 433 other followers