Expanded Access Protocol for Tabelecleucel in Subjects With EBV-Associated Viremia or Malignancies
Status: | Available |
---|---|
Conditions: | Infectious Disease, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/19/2018 |
Contact: | Atara Biotherapeutics, Inc. |
Email: | clinicaltrials@atarabio.com |
Phone: | (805) 603-4856 |
Multicenter Expanded Access Protocol of Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
The primary objective of this protocol is to provide access to tabelecleucel to patients with
Epstein-Barr virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+
primary immunodeficiency lymphoproliferative disease (PID LPD), EBV+ acquired
immunodeficiency (AID) LPD, and EBV viremia for whom there are no other approved therapeutic
options, and who are not eligible to enroll in clinical studies designed to support the
development and registration of tabelecleucel.
Epstein-Barr virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+
primary immunodeficiency lymphoproliferative disease (PID LPD), EBV+ acquired
immunodeficiency (AID) LPD, and EBV viremia for whom there are no other approved therapeutic
options, and who are not eligible to enroll in clinical studies designed to support the
development and registration of tabelecleucel.
Inclusion Criteria:
1. Any of the following diagnoses of EBV+ disease:
1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) or solid organ
transplant (SOT) and who cannot be treated under protocols designed to support
drug development or registration
2. Persistent EBV viremia as evidenced by 2 serial serum EBV deoxyribonucleic acid
(DNA) assays showing detectable EBV viremia at least 4 weeks apart, and known or
suspected immunodeficiency, or EBV viremia with a history of prior EBV+
malignancy
3. EBV+ LPD that has developed in the setting of an AID
4. EBV+ LPD that has developed in the setting of a known or suspected PID
2. Evidence of EBV positivity as follows:
1. Biopsy showing EBV+ disease, OR
2. A combination of circulating EBV DNA AND radiographic appearance consistent with
an EBV+ malignancy, if biopsy is not clinically feasible, OR
3. For EBV viremia only, fulfillment of inclusion criteria 1b
3. Relapsed or refractory disease, which is defined as:
1. In patients with PTLD following HCT: relapsed after or refractory to reduction of
immunosuppression and an anti-CD20 monoclonal antibody (unless investigator
determines tumor to be CD20-) as a single agent or in combination with
chemotherapy. Patients with CD20- disease must have failed chemotherapy alone.
2. In patients with PTLD following SOT: relapse after or refractory to reduction of
immunosuppression, an anti-CD20 monoclonal antibody (unless investigator
determines tumor to be CD20-) plus anthracycline based chemotherapy. Patients
with CD20- disease must have failed chemotherapy alone.
3. In patients with EBV viremia: Viremia that persists or recurs despite therapy
with an anti-CD20 monoclonal antibody
4. In patients with PID LPD: relapsed after or refractory to an anti-CD20 monoclonal
antibody (unless investigator determines tumor to be CD20-) as a single agent or
in combination with a chemotherapy
5. In patients with AID LPD: have failed at least two prior lines of therapy, one of
which is an anti-CD20 monoclonal antibody (unless investigator determines tumor
to be CD20-) plus anthracycline based chemotherapy (Note: Remission consolidation
with an autologous or allogeneic stem cell transplant will not be considered as a
separate line of therapy).
4. Not eligible for any other studies supporting development of tabelecleucel
5. For patients with PTLD in the allogeneic HCT setting, the underlying disease for which
allogeneic HCT was performed is in morphologic remission
6. Adequate organ function per the following:
1. Absolute neutrophil count ≥ 500/μL, with or without cytokine support
2. Platelet count ≥ 20,000/μL, with or without transfusion support
7. Patient or patient's representative is willing and able to provide written informed
consent
Exclusion Criteria:
1. Burkitt's lymphoma, classical Hodgkin's lymphoma, plasmablastic lymphoma, or any
T-cell lymphoma
2. Any investigational therapy received within 4 weeks prior to Cycle 1 Day 1, except for
therapy that is outside of 5 half-lives from the most recent dose to Cycle 1 Day 1
3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1
mg/kg/day, as prednisone equivalent
4. Need for vasopressor or ventilatory support, unless deemed to be caused by the
EBV-driven process that tabelecleucel is intended to treat
5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or
T-cell immunotherapy (donor lymphocyte infusion, other CTLs) ≤ 4 weeks prior to Cycle
1 Day 1
6. Pregnancy
7. Female of childbearing potential or male with a female partner of childbearing
potential unwilling to use a highly effective method of contraception, except when, in
the opinion of the treating physician in consultation with the medical monitor, the
risk/benefit of tabelecleucel therapy favors proceeding
8. Inability to comply with protocol procedures
We found this trial at
24
sites
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 215-590-2255
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-4826
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-7746
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-3250
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-494-0829
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Phone: 206-667-1959
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-3942
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6640
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-4090
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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410 West 10th Avenue
Columbus, Ohio 43210
Columbus, Ohio 43210
Phone: 614-293-3196
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Houston, Texas 77030
Phone: 713-792-6620
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-3148
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-6715
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-342-0530
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-454-2743
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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