Category: Clinical Trials

Immunotherapy More Effective in Treating Aggressive Lymphoma than Chemotherapy

Dr. Adrienne Phillips
Dr. Adrienne Phillips

According to findings from a recent clinical trial, people with relapsed or refractory adult T-cell leukemia-lymphoma (ATLL) may have a promising new treatment option. This new option is mogamulizumab, an immunotherapy that augments the immune system in its fight against this aggressive form of lymphoma. The lead author of the study is Dr. Adrienne Phillips, an assistant professor of medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and an oncologist with the Bone Marrow and Stem Cell Transplant Program at NewYork-Presbyterian/Weill Cornell Medical Center.

The findings of a small clinical trial demonstrate that the antibody drug mogamulizumab, known as moga, induces tumor responses in nearly 28 percent of patients with a fast-growing and difficult to treat blood cancer called relapsed or refractory adult T-cell leukemia-lymphoma (ATLL). These response rates appeared better than the standard chemotherapy comparison results in this study. The investigators say moga may represent a breakthrough in treating ATLL, for which there are currently no drugs approved in the United States to specifically treat the disease. Mogalizumab binds to CCR4 proteins on tumor cells, allowing the immune system to better target them.

“In order to treat an aggressive cancer such as ATLL, you have to think outside the box,” said Dr. Adrienne Phillips…”By working with international collaborators to conduct the largest randomized trial ever in relapsed or refractory forms of this devastating cancer, we have been able to demonstrate the benefits of an innovative, immune based treatment approach and have taken a large step forward in efforts to make this treatment option available for ATLL patients here.”

Dr. Phillip’s findings were presented during the annual meeting of the American Society for Clinical Oncology (ASCO) on June 5th in Chicago. You can read more about her finding’s here.

New Clinical Trial: A Phase 1 Study to Investigate the Safety & Tolerability of REGN1979 in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-Directed Antibody Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with CD20+ B-cell malignancies, including B-NHL’s and CLL. The study is sponsored by Regeneron Pharmaceuticals, Inc. and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CD20+ B-cell malignancy (B-NHL or CLL), with active disease not responsive to prior therapy.
  • Prior treatment with an anti-CD20 antibody therapy.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with CD20+ B-cell malignancies, including B-NHL and CLL.

The anti-CD20 monoclonal antibody (mAb), rituximab, has dramatically improved the prognosis for patients with NHL, and has been a mainstay of treatment since its first approval in 1997. While rituximab has single-agent activity in both indolent and aggressive NHL, and more modest activity in CLL, the standard of care is to use it in combination with chemotherapy. Response rates to conventional therapy are generally greater than 50%, but most patients will relapse. In the relapsed or salvage setting, there are no standard of care options and the choice of therapy is often guided by patient clinical factors, including performance status and the presence of comorbidities. Additionally, there is a growing body of data demonstrating the development of diminished activity of rituximab and rituximab resistance over time in multiple NHL subtypes.

REGN1979 is a bispecific (anti-CD20 and anti-CD3) monoclonal antibody, designed with a novel mechanism of action that is distinct from that of other anti-CD20 antibodies, and as such may provide a therapeutic benefit in patients who have relapsed following anti-CD20 mAb therapy. This first in human phase 1 study is designed to investigate the safety and tolerability of REGN1979.

Subjects will be assigned to a dose level cohort that will consist of an initial starting dose, followed by a higher dose for all subsequent administrations. REGN1979 will be administered as an IV infusion, weekly for the first four weeks, then monthly for five months, for a total of nine doses over six months. After completing the treatment period, subjects will have follow-up visits monthly for six months.

New Clinical Trial: A Phase 2 Study of the Efficacy & Safety of ACP-196 in Patients with Relapsed/Refractory CLL who are Intolerant to Ibrutinib Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with previously-treated chronic lymphocytic leukemia (CLL) who are intolerant to ibrutinib. The study is sponsored by the Acerta Pharma BV and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CLL.
  • At least one prior therapy for CLL.
  • Intolerant to ibrutinib.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

Btk inhibition is an established therapeutic intervention for the treatment of CLL. In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was approved in the United States for the treatment of patients with CLL who have had ≥ 1 prior therapy or 17p deletion based on high response rates with few drug-related toxicities. However, ibrutinib is not without its adverse reactions. This study will evaluate the safety and efficacy of the second-generation Btk inhibitor, ACP-196, in subjects who have previously discontinued ibrutinib therapy due to adverse reactions. Preliminary data to date suggests that ACP-196 is very well tolerated and has robust activity as a single agent in the treatment of subjects with relapsed/refractory CLL. Additionally, PK/PD results show the 100-mg BID regimen produces optimal target coverage over 24 hours, which may provide greater clinical benefit than the QD regimen of ibrutinib. This study will explore whether ACP-196, as an alternative Btk inhibitor, with a potentially distinct safety profile, may fill an unmet need in therapeutic options for patients who are intolerant to ibrutinib.

Subjects will receive ACP-196 orally twice daily continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Subjects who are continuing to tolerate and derive clinical benefit from treatment at the end of the trial may continue to receive their study treatment after discussion with the medical monitor. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.