Category: Clinical Trials

Waldenstrom’s Macroglobulinemia Clinical Database Study

The purpose of this study at Weill Cornell Medical College is to learn about what might cause lymphoma, to learn about how lymphoma harms the body, and to learn about treatments for Waldenstrom’s Macroglobulinemia.

This study is open to people being treated for Waldenstrom’s Macroglobulinemia outside of NewYork-Presbyterian/Weill Cornell, but participation would require at least one visit at Weill Cornell.

Waldenstrom’s Macroglobulinemia is a rare type of lymphoma, a disease where one of the white blood cells, the lymphocytes, increases in number more than they should. The lymphocytes in Waldenstrom’s Macroglobulinemia also secrete a protein called IgM. Excess IgM can interfere with the circulation of blood. Investigators at Weill Cornell Medical College and other institutions are collecting information about lymphoma patients and their disease, as well studying their lymphoma cells in the laboratory.

Participants in this study give their permission for the investigators to collect their clinical information for research purposes. In addition, the researchers will store participants’ blood, urine, check swab, bone marrow and/or tumor tissue samples for research studies to be performed now and in the future. In some cases, participants may be asked by their physician to provide additional samples.

By studying the clinical course of lymphoma patients and the lymphoma cells in the laboratory, we hope to learn more about what causes lymphoma. We also hope that information from these studies will help identify new treatments for people with lymphoma.

To find out more about this study please contact June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

The principal investigator of this study is Dr. Peter Martin. Click here to read Dr. Martin’s clinical and research profile.

Weill Cornell Lymphoma and PTSD Study

By Regina Jacob, MD

Update: this study is closed to enrollment. 

Coping with Lymphoma to Enhance Adjustment and Reduce Stress in Survivors (CLEAR Stress) is a study being done here at the Weill Cornell Lymphoma Program that is looking at Post-traumatic Stress Disorder (PTSD) and Post-traumatic Growth in patients diagnosed with Lymphoma (Non-Hodgkin’s, Hodgkin’s, or Waldenstrom’s Macroglobulinemia). We are looking to see if we can find which patients are more likely to develop PTSD, which patients are more likely to develop Post-traumatic Growth, and we are also looking to see if there is a correlation between the two.

Participation consists of a one-time interview, which will be approximately 60-90 minutes and is given in survey form. This can be completed in-person, over the phone, via mail, or via internet-based surveys.

Click here for more details about the CLEAR Stress study.

Study Background

What do we know about Post-Traumatic Stress Disorder (PTSD) in Cancer?

In a survey study done at Weill Cornell Medical College in 2008, it was found that up to 30% of all Lymphoma Survivors suffered from at least moderate symptoms of PTSD. This is important because PTSD can influence a survivor’s overall quality of life—contributing to both anxiety and depression that last long term. PTSD in the cancer population is not the same as the PTSD seen in war veterans—the stress is not discrete and there are more choices given to the cancer patient with regards to treatment options. Therefore, the treatments that have successfully enabled war veterans diagnosed with PTSD to rejoin society, do not work as effectively in cancer patients. As a result, physicians, nurses, social workers, and families try to prevent a cancer patient from developing PTSD.

What is Post-traumatic Growth?

Some people like to think of it as the opposite of PTSD, but it is a little more than that:  it usually involves all the positive changes a person goes through after a stressful encounter. Among cancer survivors, up to 90% of all cancer survivors report some degree of post-traumatic growth. The most common being: stronger relationships with friends/family, a newfound appreciation for life, a stronger sense of self, and a stronger sense of spirituality.

What is the relationship between PTSD and Post-traumatic Growth?

Thus far, there is a very little data about the correlation between Post-traumatic Growth and PTSD. Most physicians and psychologists believe that patients who demonstrate more Post-traumatic growth will also demonstrate less PTSD (which is very desirable since the treatments available for PTSD are not as effective in cancer patients). Ideally, if health care professionals can understand which patients are at a higher risk for developing PTSD, then we might be able to prevent PTSD in the first place.

For more information about the CLEAR Stress study or if you are interested in participating, call Dr. Jacob at (646) 962-5027 or e-mail Dr. Jacob at rej2008@med.cornell.edu

ASH: What is the role of rituximab maintenance in patients with low tumor burden follicular lymphoma?

By Peter Martin, MD

The optimal management of patients with newly diagnosed low tumor burden follicular lymphoma is uncertain. In the pre-rituximab era, multiple randomized phase 3 trials demonstrated the acceptability of a period of observation prior to initiation of chemotherapy. This period, which typically lasted for about three years, was considered beneficial because it allowed patients to enjoy a prolonged period of time before experiencing side effects associated with treatment. The development of rituximab led some clinicians to question the value of deferred therapy.

The ECOG 4402 trial (RESORT trial), presented at the American Society of Hematology (ASH) meeting, is a phase 3 trial in which patients with newly diagnosed low tumor burden follicular lymphoma were treated with single-agent rituximab and responders were randomized to either maintenance therapy with one dose of rituximab every three months or rituximab retreatment at the time of lymphoma progression. The goal was to determine which strategy was associated with a longer duration of benefit from rituximab.

At three years of follow-up, 95% of patients receiving maintenance rituximab and 86% of patients randomized to rituximab retreatment remained free of cytotoxic chemotherapy, a significant improvement over historical strategies with observation. Interestingly, despite receiving an average of almost four times as much rituximab (15.8 doses vs. 4.5 doses), patients randomized to maintenance rituximab did not experience a longer time to treatment failure or a better quality of life than those randomized to rituximab retreatment. The investigators concluded that maintenance rituximab should not be considered standard of care in patients with low tumor burden follicular lymphoma treated with single-agent rituximab at the time of diagnosis.