Trial Title:
A Study of Radiation Therapy Before CAR T Cell Therapy for People with B Cell Lymphoma
NCT ID:
NCT05574114
Condition:
Non-Hodgkin Lymphoma
Non-Hodgkin's Lymphoma, Relapsed
Non-Hodgkin's Lymphoma Refractory
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Conditions: Keywords:
Split-Course Bridging Radiotherapy
CD19 CAR T-Cell Therapies
22-217
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
This is a single arm, Phase I trial designed to describe the feasibility and safety of a
standardized, stage-adapted, split-course BRT regimen prior to standard of care,
commercial anti-CD19 CAR T-cell therapy. This design incorporates a small early safety
cohort with the option for a potential patient expansion cohort.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Bridging radiotherapy (BRT)
Description:
RT Part I. The target will be to complete the 9th fraction of radiotherapy (i.e., total
of 27Gy) between days -12 and -8 Day -2: BRT Part II (intervention is one fraction 3 Gy
to receive a total dose of 3 Gy).
Arm group label:
Radiation Therapy Before CAR T Cell Therapy
Intervention type:
Drug
Intervention name:
Conditioning chemotherapy
Description:
Day -5 to -3: Patients will receive standard of care lymphodepleting chemotherapy
Arm group label:
Radiation Therapy Before CAR T Cell Therapy
Intervention type:
Biological
Intervention name:
CAR T-cell product
Description:
Day 0: Subject will receive standard of care infusion of a manufactured commercial CAR
T-cell product.
Arm group label:
Radiation Therapy Before CAR T Cell Therapy
Summary:
The purpose of this study is to test whether radiation therapy given before standard CAR
T cell therapy is a safe and effective treatment for people with relapsed and refractory
B cell lymphoma. The researchers will also study whether radiation therapy used in this
study is a practical treatment option before standard CAR T cell therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed, relapsed or refractory non-Hodgkin lymphoma patients
eligible for a CAR T-cell therapy, such as DLBCL (including transformed follicular
lymphoma), high grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and
follicular lymphoma of any grade
- Patient is approved for, and planned to receive, anyone of the three commercially
available anti-CD19 CAR T-cell products (axicabtagene ciloleucel, maraleucel or
tisagenlecleucel)
- Patient has at least one site of disease with avidity greater than liver on a
screening FDG-PET scan performed within 2 months of RT simulation. Measurable
disease is not required.
- Active secondary central nervous system (CNS) lymphoma is allowed
- Age 18 or older
- ECOG status ≤2
- Adequate bone marrow function without a requirement for blood product transfusion or
growth factor support in the previous 7 days, unless the cytopenias are felt to be
due to the underlying lymphoma in the best judgement of the study investigator:
- Active secondary central nervous system (CNS) lymphoma is allowed
- Age 18 or older
- ECOG status ≤2
- Female subjects of childbearing potential should be willing to use 2 methods of
birth control or be surgically sterile or abstain from sexual activity for the
course of the study through 120 days after the last dose of radiotherapy. Subjects
of childbearing potential are those who have not been surgically sterilized or have
not been free from menses for > 1 year. Note: Abstinence is acceptable if this is
the established and preferred contraception for the subject
- Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study
therapy. Note: Abstinence is acceptable if this is the established and preferred
contraception for the subject
Exclusion Criteria:
- Subject is planned to receive any systemic therapy after initiation of BRT and
before re-infusion of CAR T cells including conventional chemotherapy, immunotherapy
or targeted agents [Note: Planned lymphodepletion chemotherapy in preparation for
CAR T cell administration is not an exclusion criterion]
- Subject has received prior RT to any site(s) planned for bridging therapy such that
the composite dose considering the protocol-mandated BRT would exceed normal tissue
tolerances in the determination of the investigator.
- The treating investigator deems that it would be impossible to comprehensively treat
the patient with radiotherapy given concerns about feasibility or potential
toxicities
- Current or planned pregnancy
- Known additional malignancy that is progressing or requires any treatment other than
active surveillance or hormonal therapy. Exceptions include basal cell carcinoma of
the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has
undergone potentially curative therapy.
- Subject has any significant medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from participating in the study
based on the investigator´s judgment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
M Lia Palomba, MD
Phone:
646-608-3711
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Contact backup:
Last name:
Brandon Imber, MD
Phone:
631-212-6346
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
West Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Lia Palomba, MD
Phone:
646-608-3711
Start date:
October 5, 2022
Completion date:
October 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574114
http://www.mskcc.org/mskcc/html/44.cfm
