Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

In the experimental group, stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, with LDRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.

In the control group, stereotactic body radiotherapy (SBRT) alone is performed. SBRT is administered three times, at intervals of 1-2 days. The scattered dose should not exceed EQD2 2Gy to the non-irradiated lesion.

SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.

The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.

LDRT is planned to irradiate EQD2 (α/β=10) 6 Gy to lesions, considering the scattered dose caused by SBRT.

If there are non-irradiated lesions, they are defined as internal control, and the total dose is limited to 0.5 Gy or less.

CTV allows up to 5 mm margin for GTV, and 3-10mm for PTV margin from CTV. It is planned that the iso-dose line corresponding to the prescribed dose contains at least 90% of PTV and 95% of GTV.

SBRT + LDRT

SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.

The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.

SBRT alone

Jae Sik Kim, MD

Ah Ram Chang, MD, PhD

Stereotactic body radiotherapy (SBRT) has been known to enhance the abscopal effect by up to 40% when delivered with immune checkpoint inhibitors (ICIs). Recently, preclinical and clinical studies demonstrate that metastatic lesions treated with non-cytotoxic low-dose radiotherapy (LDRT) significantly were reduced in the condition where SBRT and ICIs were administered together. Given that ICIs are highly expensive and some tumors are beyond the indications of ICIs, novel approaches are required to boost the abscopal effect in the absence of ICIs. Therefore, the investigators design a multicenter, randomized clinical trial that investigates the efficacy and safety of LDRT combined with SBRT in metastatic cancer patients. The primary endpoint is a lesion-specific response of LDRT lesions (i.e., abscopal effect) evaluated three months after radiotherapy.

Subjects will be randomly allocated into two groups (1:1) with the stratification by planning target volume and previous use of ICIs: control group (SBRT in three fractions) or experimental group (SBRT + LDRT in three factions). Unless patients agree with randomization, subjects will participate in a prospective cohort study.

Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy

Abscopal Effect From the Addition of Low-dose Radiotherapy in Metastatic Cancer Patients Receiving Stereotactic Body Radiotherapy: a Multicenter, Randomized Clinical Study

SMG-SNU Boramae Medical Center

Soonchunhyang University Hospital

Director of Radiation Oncology

Stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.

Byoung Hyuck Kim, MD, PhD

Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.

Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

Abscopal Effect From the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)

The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1

The proportion of patients showing complete or partial response of metastatic lesions

From the date of enrollment to the date of progression or death assessed by RECIST v1.1

From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1

The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0

Saint Vincent's Hospital, Korea

Seoul National University Hospital

Chungnam National University Hospital

Infections

Blood and Lymph Conditions

Immune System Diseases

Wounds and Injuries

Rare Diseases

Syndrome

Recurrence

Leukemia

Fatigue

Communicable Diseases

Body Weight

Leukemia, Lymphoid

Anemia

Thrombocytopenia

Weight Loss

Hyperthermia

Lymphadenopathy

Leukemia, Lymphocytic, Chronic, B-Cell

Fever

Leukemia, Prolymphocytic

Lymphocytosis

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Body Weight Changes

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Blood Platelet Disorders

Cytopenia

Leukocytosis

Leukocyte Disorders

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Richter Syndrome

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.

Ex Vivo-activated Autologous Lymph Node Lymphocytes

Laboratory Biomarker Analysis

Chitra Hosing

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)

Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.

To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia

The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.

To study the incidence of infections for up to 1 year following activated T cell infusion

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.

Receive lymphodepletion chemotherapy followed by activated T-cell infusion

Arm A

Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L

Arm B

Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion

Arm C

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All patients were enrolled in Arm C at the physician's discretion and there is no analysis to compare between the lenalidomide Arm A vs the non-lenalidomide Arm B

Dr. Chitra Hosing / Stem Cell Transplantation

Sucessful Target T-cell Dose

Feasibility

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy	NCT05578274	Neoplasms Secondary Malig...	SBRT + LDRT SBRT alone	19 Years -	Soonchunhyang University Hospital
Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy	NCT05733156	Neoplasms Secondary Malig...	SBRT + LDRT	19 Years -	Soonchunhyang University Hospital
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia	NCT02530515	Anemia Cancer Fatigue Chronic Lymphoc... Fever Infectious Diso... Lymphadenopathy Lymphocytosis Night Sweats Prolymphocytic ... Recurrent Chron... Richter Syndrom... Secondary Malig... Thrombocytopeni... Weight Loss	Ex Vivo-activat... Laboratory Biom...	-	M.D. Anderson Cancer Center

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