transplant and cellular immunotherapy news - bmtga.com · bmt program at northside hospital (nsh...

FALL 2018 ISSUE

Transplant and Cellular Immunotherapy NEWS

African American Patients Have Particularly Good Outcomes Following Allogeneic Transplantation Using HLA-Haploidentical Donor Transplants Using Approach Pioneered by the BMT Program at Northside Hospital (NSH BMT)Allogeneic hematopoietic cell transplanta-tion (allo-HCT) is an established curative therapy for many patients with some he-matologic malignancies that may be difficult to eradicate using alternative treatment. Allo-HCT requires an available donor but only approximately a third of patients will have a conventional matched sibling donor. Furthermore, the ability to find an ade-quately matched unrelated donor (MUD) in patients who lack a matched sibling is highly dependent on patient race. Whereas great-er than 70% of Caucasian patients will have access to a MUD who is optimally matched (matched at 8 of 8 HLA-A, B, C and DRB1 alleles), less than 20% of African American patients will be able to find such a donor.1

In contrast, almost all patients includ-ing those from ethnic minorities will have access to a family member who is HLA-haploidentical (ie, shares one HLA-haplotype, HID). The use of HID with conventional methods of graft-versus-host disease (GVHD) prevention has historically led to unacceptable rates of severe GVHD, graft-failure, infections and non-relapse mortality (NRM). However, the recent use of strategies for HID transplantation employ-ing T-cell replete grafts and Post-Transplant

Cyclophosphamide (PTCy) based GVHD prevention as developed by the teams at Johns Hopkins University and Northside Hospital have proved much safer and more effective. Indeed, comparisons of large numbers of patients contemporaneously transplanted at Northside Hospital have demonstrated equivalent survival, disease- free survival and NRM for HID transplants using PTCy when compared to conventional transplants using matched sibling donors and optimally matched unrelated donors.2,3 These results have now been replicated in multiple other studies worldwide. HID transplantation using PTCy has been a particular boon to African American pa-tients, those from other minorities, and mixed-race patients by considerably reliev-ing problems related to donor availability for those groups.

Previous studies comparing outcomes of African American patients to Caucasian pa-tients who undergo conventional MUD4 or even cord blood donor5 transplants have generally shown that African American patients have worse overall outcomes with such transplants. No prior comparisons of outcomes by race following HID trans-plants using PTCy have been performed. In this regard, a recently published study by investigators from NSH BMT shows that African American patients do remarkably well following this type of transplant.6

In an analysis of 203 consecutive HID transplants using PTCy performed for he-matologic malignancies (54% AML/myeloid malignancies, 24% NHL/HL, 17% ALL) at NSH BMT with mature follow-up (median 36 months), three-year outcomes were di-rectly compared between African American and Caucasian patients. Kaplan-Meier esti-mates of overall survival and disease-free

IN THIS ISSUE:

p2 Northside Cancer Institute is a Certified Yescarta® CAR T-Cell Therapy Treatment Center

p3 How Does CAR T-Cell Therapy Work?

Northside Hospital’s New Blood and Marrow Transplant, Leukemia and Immunotherapy 56-Bed Inpatient Unit Now Open

p4 2018 Leukemia and Lymphoma Society Blood Cancer Conference; Dr. Kent Holland Presents, Immunotherapy: The Future of Cancer Therapy

BMTGA Launches New Mobile-Friendly Website

26th Annual Northside Charity Golf Tournament

Dunwoody Rotary Club: Northside Cancer Institute Immunotherapy Program Presents CAR T-Cell Therapy

p5 Open Clinical Trials

(continued on page 2)

100A

B

80

60

40

20

00 1 2

Caucasion (N=123)African American (N=80)

P<0.001

P<0.001

P=0.12

P=0.015

3 4 5Years since transplant

Pro

bab

ility

of

surv

ival

(%)

Cum

ulat

ive

inci

den

ceof

rel

apse

(%)

Pro

bab

ility

of

dis

ease

-fre

e su

rviv

al (%

)

Cum

ulat

ive

inci

den

ceof

NR

M (%

)

6 7 8 9 10

100C

80

60

40

20

00 1 2



6 7 8 9 10

100

80

60

40

20

00 1 2



6 7 8 9 10

100D

80

60

40

20

00 1 2



6 7 8 9 10

2 | FALL 2018 ISSUE Transplant & Cellular Immunotherapy NEWS

(continued from page 1)survival were 72% and 65% in African American patients versus 50% and 45% in Caucasian patients (p<0.001 on log rank comparison).6 Both African American and Caucasian patients had similar low rates of NRM (11% and 16%, p=NS). In contrast, three-year cumulative incidence of relapse (CIR) of malignancy was significantly lower in African American patients (25% versus 39% p=0.015). Although the African American and Caucasian patients were well matched for other characteristics, a multivariable analysis was per-formed to adjust for possible confounding variables. The differences remained significant – hazard ratio (HR) for African American versus Caucasian patients was 0.47 for overall survival (p=0.003), 0.49 for disease-free survival (p=0.0028) and 0.49 for CIR (p=0.01). On a Forest plot, the advantage for African American patients was particularly significant with higher-risk malignancies, reduced-intensity conditioning, and for female patients.

This landmark study is the first ever to demonstrate superior outcomes for African American patients compared to Caucasian patients undergoing allo-HCT. It highlights the dramatic positive impact that the development of HID trans-plantation using PTCy has had upon prospects for patients of this ethnicity who need an allo-HCT for hematologic

malignancy. It also demonstrates that HID transplants using PTCy can be performed with a remarkable safety (three-year non-relapse mortality of 11% in this unselected population). The primary reason for the superior outcomes seen in African American patients appears to be a lower relapse rate in African American patients. The reasons un-derlying this remain unclear. African Americans may have a more diverse spectrum of HLA haplotypes than Caucasian patients and it is possible that there is greater antigenic dis-parity between the patient and donor for the unmatched HLA-haplotypes which may in turn result in a stronger graft-versus malignancy effect in such patients following HID transplants. An early analysis of epitope mismatching between donor and recipient between African American and Caucasian patients undergoing HID transplants at our center did not show a significant difference (unpublished data). However, other analyses including non-HLA factors may be necessary to further study this phenomenon.

1. Gragert L, et al. N Engl J Med. 2014;371:339-48.2. Bashey A, et al. Biol Blood Marrow Transplant. 2016;22:125-33.3. Bashey A, et al. J Clin Oncol. 2013;31:1310-6.4. Baker KS, et al. Biol Blood Marrow Transplant. 2009;15:1543-54.5. Ballen KK, et al. Biol Blood Marrow Transplant. 2010;16:1025-31.6. Solomon SR, et al. Biol Blood Marrow Transplant. 2018;24:1237-42.

Northside Cancer Institute is a Certified Yescarta® CAR T-Cell Therapy Treatment Center Northside Hospital is a certified treatment center for Yescarta®, (axicabtagene ciloleucel), which is a CD19-directed genetically modified autologous T cell immunotherapy and is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. It is the first-ever FDA-approved CAR T-cell therapy for certain types of non-Hodgkin lymphoma (NHL).

Our program meets the rigorous requirements of the manufacturer, in addition to meeting all accreditation standards through the Foundation for the Accreditation of Cellular Therapy (FACT).

The program has an efficient CAR T-cell referral and finan-cial approval process After treatment and follow up care is completed, patients will return to their primary oncologist.

To make a CAR T-cell referral, or to speak with a physician, please call 404-255-1930.

For additional CAR T-cell information, visit www.northside.com/immunotherapy or bmtga.com.

3FALL2018 ISSUE |Northside Hospital Blood & Marrow Transplant Program

• A specialized pharmacy with the capacity to mix chemotherapy/immunotherapy agents

• A comfortable family room for caregivers, with computers, internet accessibility and disease-related literature

Having access to cutting-edge diagnostic testing, facilities, comprehensive patient-centered care, and a highly-trained team provide our patients with exceptional quality care that results in outstanding survival outcomes and patient satisfaction.

“Northside provides high-quality care in a very personal environment, a highly compassionate environment, and our patients are the beneficiaries,” said Dr. Scott Solomon, Medical Director of Northside’s Blood and Marrow Transplant (BMT) Matched Unrelated Donor Program and Stem Cell Processing Laboratory. “Patients at Northside Hospital do very well; they have access to high-quality clinical trials and certainly exceptional cancer care, but it is the compassion of the individuals who work here that make Northside a unique and special place.”

Northside Hospital’s New Blood and Marrow Transplant, Leukemia and Immunotherapy 56-Bed Inpatient Unit Now OpenOn May 1, 2018, the Blood and Marrow Transplant Group of Georgia physicians, unit leadership team and staff members participated in a ribbon-cutting ceremony to celebrate the opening of this new 56-bed, state-of-the-art inpatient unit.

The new unit includes these unique features:• It is used solely for patients undergoing blood and

marrow transplant, leukemia, and immunotherapy treatment

• Specialized infection prevention features• All rooms are private, have bedside computers, and

have dedicated equipment to assist with complete assessments

A state-of-the-art infection prevention bundle includes the following benefits and amenities:

• All patient rooms provide a protective environment designed with solid ceilings and double HEPA-filtration

• Positive pressure rooms with negative pressure ante-rooms

• Solid surface bathrooms• Disposable privacy and shower curtains• An exercise room for patients• A dedicated family bathroom with shower

How Does CAR T-Cell Therapy Work?


26th Annual Northside Charity Golf Tournament

Dunwoody Rotary Club: Northside Cancer Institute Immunotherapy Program Presents CAR T-Cell Therapy

This year’s Northside Charity Golf Classic was held on Monday, May 21, 2018, at the Atlanta Athletic Club (AAC) and raised $519,000.00 to benefit the Northside Hospital Blood & Marrow Transplant and Cancer Research Programs. We would like to thank the Northside Foundation and the many golfers who participated in this important fundraising event. Congratulations to all of our winners!

Make sure to save the date for next year: Monday, May 20, 2019, at AAC

On August 24, 2018, Connie Sizemore, Pharm.D, Program Lead Clinical Pharmacy Specialist, presented an overview of Northside’s CAR T-cell therapy program to members of the Dunwoody Rotary Club. Dr. Sizemore reviewed what immunotherapy is, which cancers respond to immunotherapy, and how CAR T-cell therapy has become an exciting new treatment for blood cancers.

Northside Hospital Foundation is a 501(c)(3) non-profit organization dedicated to Northside Hospital and the enrichment of the communities we serve.

To see more photos from the tournament, go to https://eventgallery.btapb.com/charitygolf2018/

BMTGA Launches New Mobile-Friendly WebsiteIn May 2018, BMTGA launched their new mobile-friendly website. Using a new website platform, all NSH BMT, leukemia and immunotherapy program information, from complex graphics to monthly clinical research protocol listings, can now be loaded and easily viewed on all mobile devices.

2018 Leukemia and Lymphoma Society Blood Cancer ConferenceDr. Kent Holland Presents, Immunotherapy: The Future of Cancer Therapy

On July 21, 2018, the Georgia Leukemia and Lymphoma Society Chapter held their annual educational Blood Cancer Conference for patients, caregivers, survivors and healthcare professionals. Over three hundred attendees participated in educational sessions ranging from managing financial concerns during cancer treatment, to caregiver support, to presentations on

current disease treatments for leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. Dr. Kent Holland gave an overview of the many new immunotherapy treatments available with an emphasis on chimeric antigen receptor T-cell therapy, also known as CAR T-cell, which is now available at Northside Hospital. For additional immunotherapy information, please visit bmtga.com/immunotherapy-program-at-northside or northside.com/immunotherapy.

5FALL2018 ISSUE |Northside Hospital Blood & Marrow Transplant Program

Open Clinical Trials

Disease Trial Number Name of TrialDrug Name

ClinicalTrials.gov Identifier

ALL NSH1099 E1910: Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B-ALL in Adults

Blinatumomab NCT02003222

AML NSH1150 Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation

Pembrolizumab NCT02771197

AML NSH1164 A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients with CD123-Expressing Hematologic Malignancies

XmAb® 14045 NCT02730312

NHL NSH1206 A Phase II Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects with High-Risk Diffuse Large B-cell Lymphoma Post-Autologous Hematopoietic Stem Cell Transplantation


NHL NSH1210 A Phase II Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Loncastuximab Tesirine NCT03575351

CAR T-Cell: NHL NSH1170 A Phase I, Multicenter, Open-Label Study of JCAR017, CD19-Targeted Chimeric Antigen Receptor (CAR) T-cells, in Relapsed and Refractory (R/R) B-Cell Non-Hodgkin Lymphoma

JCAR017 NCT02631044

CAR T-Cell: NHL NSH1207 A Global Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects with High-Risk, Transplant-Eligible Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (TRANSFORM)

JCAR017 NCT03575351

CAR T-Cell: Multiple Myeloma

NSH1216 (open in December 2018)

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of bb2121 versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (rrMM) (KarMMa-3)

NCT03651128

AML NSH1144 A Phase II, Randomized, Biomarker-Driven, Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia With an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML and Exploratory Arms with Varying Levels of MCL-1 Dependence

Alvocidib NCT02520011

AML NSH1150 Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation

Pembrolizumab NCT02771197

AML NSH1164 A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients with CD123-Expressing Hematologic Malignancies

XmAb® 14045 NCT02730312

AML NSH1169 A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia Sel24 NCT03008187

AML NSH1208 A Phase I Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients With Hematologic Malignancies

Vyxeos NCT03555955

AML NSH1217 (Open early 2019)

A Phase 1/2, Open-Label, Multicenter 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticle as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia/Myelodysplastic Syndrome Patients Not Eligible for Intensive Induction Therapy.

Pending

AML NSH1209 Multicenter, Open-Label Treatment Protocol of Gilteritinib (ASP2215) in Patients with FMS-Like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) with Minimal Residual Disease (MRD)

Gilteritinib NCT03070093

Multiple Myeloma NSH1107 A Phase II Trial of High-Dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Upfront Treatment of Multiple Myeloma

Bendamustine NCT02416206

Aplastic Anemia NSH1158 A Study of T-cell Replete, HLA-Mismatched Bone Marrow Transplantation with Post-Transplant Cyclophosphamide as a Front-Line Therapy for Patients with Severe Aplastic Anemia Lacking HLA-Matched Related Donor

Fludarabine Cyclophosphamide NCT02828592

Sickle Cell Disease

NSH1184 Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease

NCT03263559

IMM

UN

OTH

ERA

PYA

ML

(continued on page 6)

TRA

NSP

LAN

T

Disease Trial Number Name of TrialDrug Name

ClinicalTrials.gov Identifier

AML NSH1182 BMT CTN 1506 Randomized Trial of FLT3 Inhibitor vs Placebo as Maintenance Therapy Post Allogeneic Transplant

Gilteritinib NCT02997202

NHL NSH1206 A Phase II Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects with High-Risk Diffuse Large B-Cell Lymphoma Post-Autologous Hematopoietic Stem Cell Transplantation


NSH721 NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository

NCT00495300 (sample) NCT01166009 (database)

NSH943 A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications

NCT01351545

NSH995 A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

NCT01656603

Open Clinical Trials (continued)

SUPP

ORT

IVE

CA

RE

OTH

ER


Blood & Marrow Transplant Group at Northside Hospital

5670 Peachtree Dunwoody Road Suite 1000

Atlanta, GA 30342

404-255-1930

transplant and cellular immunotherapy news - bmtga.com · bmt program at northside hospital (nsh...

Documents