Symptoms and General Pathology

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Acute Graft Versus Host Disease

Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Allogeneic Hematopoietic Stem Cell Transplantation

Irradiated Allogeneic Cells

Roger Strair

This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.

PRIMARY OBJECTIVES:

I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.

SECONDARY OBJECTIVES:

I. To determine if there is evidence of disease response associated with IHC.

TERTIARY OBJECTIVES:

I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

After completion of study treatment, patients will be followed up within 8 weeks.

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

Post-Transplant Use of Irradiated Haplo-Allogeneic Cells

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu

It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Professor of Medicine, RWJMS

no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I

Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC

Irradiated Allogeneic Cells: Correlative studies

Cohort I (Initial IHC Within 42 Days)

Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC

Irradiated Allogeneic Cells: Correlative studies

Cohort II (Initial IHC Within 70 Days or After Relapse)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Roger K. Strair, MD

no data was collected. Refers to the Cohort 1 Arm

Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response

the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Induction of Host T Cells Reactive With Tumor Associated Epitopes

Overall Study

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Adenomatous Polyposis Coli

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA

co-occuring mutation

This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.

Patogenic Mutation in 5 Genes

Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal

grade, stage, lymphovascular invasion, tumor location

Dr Cipto Mangunkusumo General Hospital

Principal Investigator - Staff of Digestive Division - General Surgery Department

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week.

Inger Marie Løes, MD PhD

Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.

Single center, open labeled, phase 2 clinical trial, where patients are selected for treatment based on upfront TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the single treatment arm. The informed consent, however needs to be signed prior to a biopsy for TP53 mutation analyses; thus, all patients are formally enrolled in the study prior to tissue collection, and the full population tested will be accounted for despite the fact that only patients with TP53 mutated tumors may enter the single treatment arm.

The p53 Colorectal Cancer Trial

Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial

Partial response (PR) or complete response (CR) as defined by the RECIST criteria

Tissue and blood sampling at baseline and whenever treatment is changed

Haukeland University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies	NCT03272633	Acute Lymphobla... Acute Myeloid L... Hematopoietic C... JAK2 Gene Mutat... Loss of Chromos... Mantle Cell Lym... Minimal Residua... Myelodysplastic... Non-Hodgkin Lym... Plasma Cell Mye... RAS Family Gene... Recurrent Diffu... Recurrent Hemat... Recurrent Matur... Refractory Diff... Refractory Matu... Therapy-Related... Therapy-Related... TP53 Gene Mutat...	Allogeneic Hema... Irradiated Allo...	18 Years -	Rutgers, The State University of New Jersey
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital
The p53 Colorectal Cancer Trial	NCT03149679	Colorectal Canc... Colorectal Canc... TP53 Gene Mutat...	Cyclophosphamid...	18 Years -	Haukeland University Hospital
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies	NCT03272633	Acute Lymphobla... Acute Myeloid L... Hematopoietic C... JAK2 Gene Mutat... Loss of Chromos... Mantle Cell Lym... Minimal Residua... Myelodysplastic... Non-Hodgkin Lym... Plasma Cell Mye... RAS Family Gene... Recurrent Diffu... Recurrent Hemat... Recurrent Matur... Refractory Diff... Refractory Matu... Therapy-Related... Therapy-Related... TP53 Gene Mutat...	Allogeneic Hema... Irradiated Allo...	18 Years -	Rutgers, The State University of New Jersey
Patogenic Mutation in 5 Genes	NCT04976439	Colorectal Canc... APC Gene Mutati... TP53 Gene Mutat... PIK3CA Gene Mut... KRAS Mutation-R... MLH1 Gene Mutat...	co-occuring mut...	18 Years -	Dr Cipto Mangunkusumo General Hospital

Spots Global Cancer Trial Database for tp53 gene mutation