Multi-Center Phase II Study of Oral Azacitidine (CC-486) Plus CHOP As Initial Treatment for Peripheral T-Cell Lymphoma (PTCL)

Today, at the 2020 Annual Meeting of the American Hematology Society (ASH), the Weill Cornell Medicine T-cell lymphoma research team reported the outcome of the first phase 2 study evaluating the novel combination of oral azacitidine plus CHOP as initial treatment for patients with peripheral T-cell lymphoma (PTCL).

This multi-center phase 2 study, led by Dr. Jia Ruan, is the first of its kind to incorporate epigenetic priming with a hypomethylating agent in the frontline setting as a chemo-sensitizing strategy for PTCL. 

The study enrolled 21 PTCL patients, with the majority of them (17 patients) having the diagnosis of angioimmunoblastic T-cell lymphoma, also known as PTCL with T-follicular helper phenotype (PTCL-TFH). This phenotype is known to have recurrent genetic mutations in epigenetic regulation, providing therapeutic targets for hypomethylating agents such as azacitidine. During study treatment, the patients received CHOP on day 1 of each cycle for 6 cycles, while oral azacitidine was given for 7 days prior to CHOP cycle 1, and for 14 days before CHOP cycles 2-6.  The primary study objective was to see if the novel combination would improve complete response rates following 6 cycles of treatment.  

The study treatment was well tolerated with expected side effects associated with CHOP chemotherapy. Eighteen patients were able to complete all 6 cycles of treatment without the need for chemotherapy dose reduction. Ten patients underwent successful stem cell transplant while in remission. Complete remission (CR) was achieved in 75% of clinical trial participants at the end of 6 cycles of treatment, exceeding the pre-determined efficacy threshold (60%) to declare the treatment as effective. Notably, within the subgroup of patients with the PTCL-TFH subtype, the treatment appears to work even better with a CR rate of 88%. The one-year progression-free survival (PFS) for all patients was 66%, and for the PTCL-TFH subgroup was 70%. The one-year overall survival (OS) for all patients was 81% and PTCL-TFH patients 94%. The research team is further analyzing sequencing biomarkers to correlate with response and survival. 

This study provides the first demonstration that the addition of epigenetic hypomethylating agent oral azacitidine (CC486) to CHOP as initial therapy is safe, and highly effective to induce complete remission in PTCL. This combination will be further evaluated in the upcoming ALLIANCE/Intergroup randomized study A051902, comparing oral azacitidine-CHO(E)P with duvelisib-CHO(E)P against CHO(E)P in CD30 negative PTCL.

Abstract 40: Multi-Center Phase II Study of Oral Azacitidine (CC-486) Plus CHOP As Initial Treatment for Peripheral T-Cell Lymphoma (PTCL)

Type: Oral presentation
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Clinical Studies in T/NK Cell Lymphoma
Saturday, December 5, 2020: 7:45 AM PST

ASH 2020 Weill Cornell Medicine Lymphoma Program research coverages continues throughout the conference.

COVID-19 and Cancer: Helpful Resources for Lymphoma Patients

The Weill Cornell Medicine Lymphoma Program team remains committed to supporting and protecting the health and safety of our patient community during this challenging time. With COVID-19 dominating the news and impacting our everyday lives, many people may be left wondering which sources to trust and which recommendations to follow when it comes to understanding the coronavirus and staying safe during this unprecedented time.

We developed this article and compiled a handful of reliable resources designed to help lymphoma patients — at our center and beyond – best navigate this rapidly changing situation.

COVID-19 Basics and General Guidelines

Physicians and staff within the division of Hematology and Oncology at Weill Cornell Medicine and NewYork-Presbyterian Hospital are here to provide guidance and support to our cancer patients and their loved ones. We encourage you to review the information outlined in our COVID-19 and Cancer Guide, where we provide answers to our patient community’s most frequently asked questions. You are also welcome to call our COVID-19 hotline at (646) 697-4000 with questions at any time.

If you have COVID-19 symptoms or suspect that you have been in contact with someone with COVID-19, contact your oncologist for further instruction. If you need in-person medical attention, your doctor will advise you regarding the necessary steps and preparations to protect you and others at the facility before you arrive. Please do not visit your doctor’s office or the emergency department without first being in touch with your healthcare team.

COVID-19 and Lymphoma

In the Lymphoma Research Foundation (LRF) webinar entitled “Coronavirus and What the Lymphoma Community Needs to Know,” our own Dr. John Leonard reviews the current medical understanding and response to COVID-19 (per March 19, 2020). Dr. Leonard explains why we all must work together to “flatten the curve,” and addresses frequently asked questions surrounding immune system suppression and the coronavirus, lymphoma treatment during the pandemic, the use of masks and transmission of the disease between different groups such as children, the elderly and pets.

The LRF also created a COVID-19 fact sheet complete with prevention tips and questions to ask your oncologist. Weill Cornell Lymphoma Program Chief Dr. Peter Martin and an infectious disease specialist contributed to and medically reviewed this information.

Appointments and Video Visits

Please know that we remain dedicated to the health and wellbeing of our lymphoma community and that continuing to provide world-class cancer care for our oncology patients is important to us. As part of our mission to provide care during this unprecedented time, the Hematology & Oncology division has been implementing extensive patient-centered precautions. These include efforts to prevent the spread of COVID-19 within our facilities and the expansion of virtual video-based appointments.

The Weill Cornell Lymphoma Program continues to be able to offer new and current patients the cancer care they need. We also provide expert, multidisciplinary care for patients with lymphoma who need medical attention for COVID-19.

Video visits allow patients to receive high-quality lymphoma care from the comfort and convenience of their own homes, while adhering to safe social distancing parameters recommended to minimize exposure to other individuals. Our video visit capabilities also extend to patients who wish to schedule a virtual second opinion.

To schedule a video visit, please follow the instructions below. Our team will work with you to obtain any necessary medical records prior to your visit. We will inform you if we believe that you are better suited for an in-person visit.

New Patients
Please call (646) 962-2800.

Existing Patients
Please call (646) 962-2064.

Learn more about video visits. Once your video visit is scheduled, use this guide to connect with your doctor.

Video visits use the same insurance coverage as in-person appointments, and your copayment and deductible still apply.

Visitor Policy

While we recognize the value of family and friends’ support throughout lymphoma diagnosis and treatment, keeping patients and their loved ones safe requires temporary limits on the number of people allowed to accompany each patient to an appointment. Please note that our policies continue to evolve during these unprecedented times. Click here for our latest COVID-19 visitation guidelines.

Additional Resources

Patients are welcome to call the WCM/NYP COVID-19 hotline – (646) 697-4000 – with any questions. Please note that this hotline is available as a public service to provide information only, and not to diagnose, treat or render a medical opinion.

Patients may also consult the following resources.

Ways to Help

It can be easy to feel powerless in the midst of a global pandemic, but there are ways that you can help. In fact, the biggest impact that people – sick or healthy – can make in the fight against COVID-19 is simply to stay at home to curb the spread of disease and its potential to overwhelm the healthcare system.

Those willing and able to contribute to Weill Cornell Medicine and NewYork-Presbyterian’s response to COVID-19 can make a donation to support the purchasing of ventilators and personal protective equipment (PPE), and the physical and emotional wellbeing of healthcare workers on the frontlines of the outbreak.

A fundraiser was also created to provide nutritious, high-quality meals to the New York City doctors, nurses and ancillary staff leading the fight against COVID-19 as part of medical intensive care units.

My Name Is CC, and I Am a Cancer Survivor

“Hello, my name is CC, and I am a cancer survivor.”

I never thought that those words would sit together in the same sentence, let alone with a great deal of comfort and elbow room. I never thought that the word “cancer” would be applied to me at all. And I never thought that I would carry the words with me still, after it was all over. You see, I was hoping I would be able to tuck cancer away, someplace small and sacred, and be able to forget that I was ever that sick, forget that I ever did all that chemo, and forget that my life was forever changed.

But that’s not what happened. That’s not the story.

I was young. I was active. I was social. I was ambitious in my career and excited about the future. I was a “healthy” and “normal” 29-year-old when I was diagnosed with stage IV Hodgkin lymphoma in the sleeting February of 2016. After getting totally emotionally sidelined by the diagnosis, I completed six rounds (12 infusions total) of ABVD chemotherapy. That’s a total of 36 hours in the infusion center’s bustling waiting room, 72 hours in the chemo chair, watching 259,200 drips trickle down from the chemo bag into the big blue vein in my arm. That’s 12 lightly toasted bagels from the café downstairs, an infinite number of hand holds and arm rubs from my mother, and countless times the floor dropped out from beneath me to swirl with the walls.

WebsterSisters
With my sister, Ashley, in July 2016, before my final treatment.

When I tumbled out the other side into remission that sweaty August, I tried to pick up my life and career where I had left it, but it just wasn’t the same. Something was missing. It was like my doctor had sent me home with a stick shift when I only knew how to drive an automatic. Everything I had built for myself had seemed to disappear, sinking between my fingers. All of my dreams and my excitement for the future fell in a heap on the floor, having lost their glitter and gleam. I had to rebuild by finding and following my sense of joy, passion, peace and purpose.

My observations and perspectives surrounding my experience with cancer may ring true to anyone who has sat in that chemo chair, or who has shown up to a cocktail party with a fresh buzz cut. But more than a cancer story, my story is one of facing challenge and surviving. It is a story about the power of the physical body and the emotional self. It is a story about love. And most of all, it is story of hope, with a little bit of humor.

I want to tell my story in this blog post and in the next ones to come, with this community specifically, because this is where I came for help, too. Stay tuned. I can’t wait to share my story with you.


CCWebster_PhotoCC Webster is a recent survivor, patient of Weill Cornell Medicine/NewYork-Presbyterian (WCM/NYP), and author of So That Happened, a memoir that offers a candid reflection on her experience with cancer as a young adult. Diagnosed with Hodgkin lymphoma at the age of 29, CC completed treatment under Dr. John Leonard and his team at WCM/NYP’s Lymphoma Program. Now in remission, she is sharing her story, perspective, and insights in hopes of raising awareness of the disease and helping others through the battle – always with a little bit of humor. Her book is available on Amazon, Barnes & Noble, Goodreads, and through her site and publishing platform Webster Works. CC lives with her husband, Matt, in New York City.