Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Lymphoma, T-Cell

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Lymphoma, Mantle-Cell

Lymphoma, B-Cell

Neoplasm, Residual

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Disease Attributes

Bone Marrow Diseases

Precancerous Conditions

Neoplastic Processes

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

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

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Polycythemia Vera

Polycythemia

Disease Progression

Thrombocytosis

Thrombocythemia, Essential

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Bone Marrow Neoplasms

Myeloproliferative Disorders

Blood Platelet Disorders

Essential Thrombocythemia

Chronic Myeloproliferative Disorders

Patients not diagnosed with OSA undergo observation for 6 months.

Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

Continuous Positive Airway Pressure

Patient Observation

Questionnaire Administration

Krishna Sundar

This early phase I trial studies how well the use of a continuous positive airway pressure (CPAP) machine works in treating obstructive sleep apnea in patients with polycythemia vera or essential thrombocythemia. Obstructive sleep apnea is a condition where a person stops breathing during sleep, and is estimated to affect 30 to 50 percent of patients with polycythemia vera or essential thrombocythemia. A patient with obstructive sleep apnea typically snores, has disrupted sleep, experiences morning headaches, and has daytime sleepiness. Patients diagnosed with obstructive sleep apnea are typically treated with a device called CPAP. The CPAP provides pressurized air that keeps upper air passages open during sleep and may prevent them from narrowing or collapsing as occurs during snoring or sleep apnea.

PRIMARY OBJECTIVES:

I. To understand effects of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) on the course of polycythemia vera/essential thrombocythemia (PV/ET).

EXPLORATORY OBJECTIVES:

I. To estimate prevalence of OSA in patients with myeloproliferative neoplasms. II. To understand effects of CPAP for sleep apnea on the course of myeloproliferative neoplasms (MPNs).

III. To correlate OSA severity with thrombotic and inflammatory marker values in patients with PV/ET at baseline.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (OBSERVATIONAL COHORT): Patients not diagnosed with OSA undergo observation for 6 months.

COHORT II (TREATMENT COHORT): Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia

Modulation of Morbidity and Disease Progression in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Patients With Obstructive Sleep Apnea (OSA) by CPAP

Assessed by Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference and Gender (STOP-BANG) questionnaire. The proportion of patients whose results indicate a diagnosis of OSA will be calculated. All patients with a diagnosis of OSA, regardless of whether they are enrolled to the treatment component of the study, will be counted towards the assessment of prevalence. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

The endpoints will be summarized by mean, median, range, standard deviation, interquartile range and boxplots. Scatterplots will be used to show bivariate associations. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

Will be measured in blood samples taken from all patients. OSA-related adverse events reported in the Treatment Cohort at these timepoints will be correlated with these marker levels. Pearson or Spearman correlation will be used to assess correlation between thrombo-inflammatory markers and oximetric abnormalities.

Will be tested at the two-sided 0.025 significance level to provide overall control of the type I error for the co-primary endpoints at 0.05. The endpoints will be summarized by mean, median, range, standard deviation, interquartile range and boxplots. Scatterplots will be used to show bivariate associations. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

University of Utah

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
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah
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
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah

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