Tag: Weill Cornell Medical College

New Weill Cornell Study: Ofatumumab in Untreated Follicular Lymphoma

CALGB 50901: A Phase II Trial of Ofatumumab (CALGB IND #112390) in Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL)

The Weill Cornell Lymphoma Program is now enrolling people in a new clinical trial for patients with follicular non-Hodgkin lymphoma. Dr. Peter Martin is the physician leading the study at Weill Cornell.

For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Men and women age 18 or older
  • Follicular non-Hodgkin lymphoma (NHL)
  • No prior therapy for NHL including chemotherapy or immunotherapy
  • Detailed eligibility reviewed when you contact the study team
Study Details

This is a clinical trial for patients with follicular non-Hodgkin lymphoma (NHL) who have not been previously treated. The purpose of the study is to determine how well patients with follicular NHL respond to treatment with the drug ofatumumab.

Ofatumumab is an antibody therapy that is targeted to attack the abnormal cancer cells that make up follicular lymphoma by recognizing a protein on the surface of these cells. Ofatumumab is an effective treatment for follicular lymphoma and chronic lymphocytic leukemia that comes back after people first respond to other chemotherapy. It is not known how well ofatumumab will work in patients with follicular lymphoma who have not been previously treated.

All patients in the study will receive ofatumumab. You will be randomly assigned to receive one of two doses of ofatumumab; neither you nor the study physician can choose which dose you receive.  You will receive either 500 mg or 1000 mg of the study drug via infusion on days 1, 8, 15 and 22 during the first 4 weeks of treatment (induction therapy). Following induction therapy ofatumumab will be given every other month to cover a total of 9 months. During this time you will continue to receive the same dose, either 500 mg or 1000 mg, that you were initially assigned.

We expect patients to be receiving treatment in the study for approximately 9 months. After completing study treatment you will be asked to return for follow-up tests 11, 15, 19, 23, 27, 31, and 35 months after entering the study, and then every 6 months for a maximum of 10 years from study entry, unless your disease should return.

Lymphoma in Pregnancy

By Rebecca Elstrom, MD

Although rare, cancer, including lymphoma, does occur in pregnant women. The effect of both the cancer and treatment on the fetus is a major concern to expectant parents, adding to the stress of dealing with a diagnosis of malignancy. Some types of anti-cancer treatment, such as the anti-folate drug methotrexate, are best avoided at all stages of fetal development, and the effects of other classes are likely dependent in part on the physical characteristics of each drug, which can affect the ability of each to cross the placenta. For example, certain anthracyclines, which are critical in the treatment of lymphoma and other hematologic malignancies, cross the placenta poorly, whereas others, such as idarubicin and liposomal formulations of doxorubicin, have physical characteristics which allow greater penetration into the fetal circulation.

Fortunately, evidence is mounting that exposure of the fetus to many common types of chemotherapy after the first trimester does not produce negative effects on normal development, either in terms of organ development or neurologic function. A recent study published in the Lancet Oncology observed children born to mothers that were treated for cancer and compared their physical, behavioral and cognitive development to established norms in similar populations. The authors found that children born to mothers that were exposed to chemotherapy for treatment of cancer after the first trimester did not show notable differences in development from children in the general population matched for other characteristics. Although the numbers were too small to compare different chemotherapy regimens in their effects, the general finding of no significant decrement in development in this prospective study was encouraging. Of note, the most powerful predictor of cognitive developmental delay was premature birth, comparable to that seen in children born prematurely for other reasons. Although it is not possible to definitively rule out an additional effect of chemotherapy in this group, this finding argues that “iatrogenic prematurity,” or delivery of a baby before term for purposes of treating the mother’s cancer, is likely to be counter-productive, unless undertaken for a specific reason other than sparing the fetus exposure to chemotherapy.

Another critically important question involves the outcome of treatment for the patient. Pregnancy affects blood volume and could affect the body’s handling and metabolism of chemotherapy drugs. No large prospective studies are available to address this issue, but a presentation by Dr. Andrew Evens of the University of Massachusetts at the most recent meeting of the American Society of Hematology in December of 2011 showed excellent outcomes in a retrospective study of 88 women diagnosed with lymphoma during pregnancy. Weill Cornell Medical College participated in the study. Although the retrospective nature of the study and heterogeneity of the patients preclude definitive conclusions, this study provides more encouraging data for women facing a diagnosis of lymphoma during pregnancy. Click here to read the abstract.

New Weill Cornell Study: Aurora Kinase A Inhibitor MLN8237 in Peripheral T-Cell non-Hodgkin Lymphoma

Update: this study is closed to enrollment. 
The Weill Cornell Lymphoma Program is now enrolling people in a new clinical trial for patients with peripheral T-cell lymphoma, a type of non-Hodgkin lymphoma that generally has a poor outcome with conventional chemotherapy.

The purpose of this study is to determine the effect of the experimental drug MLN8237 on patients with relapsed or refractory peripheral T-cell lymphoma. MLN8237 is an Aurora Kinase A inhibitor that has been developed to interfere with cell division, which is required for cancer to grow. It has been shown to have anti-cancer activity in laboratory studies as well as in patients who have non-Hodgkin lymphoma including peripheral T-cell lymphoma in earlier phase I/II studies.

MLN8237 is available as a tablet. Patients will take MLN8237 on Days 1-7, twice a day with 8 ounces of water. Patients will continue with this treatment every 3 weeks for up to a year as long as their disease does not get worse. Whether patients remain on study treatment or not, the study physician will follow their health status for a maximum of 2 years from study enrollment.

Key eligibility:

  • Relapsed/refractory peripheral T-cell non-Hodgkin lymphoma
  • Must have received at least one course of prior systemic therapy which may include chemotherapy, antibody therapy or immunotherapy
  • May have received prior radiation in combination with systemic therapy
  • Must not have received a previous allogeneic stem cell transplant or be within 90 days of autologous stem cell transplant
  • Detailed eligibility reviewed when you contact the study team

For more information about the study, call June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

The physician leading the study at Weill Cornell is Dr. Jia Ruan. Click here to read Dr. Ruan’s clinical and research profile.

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