Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Anxiety Disorders

Recurrence

Depression

Depressive Disorder

Fatigue

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Acute Graft Versus Host Disease

Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

Patients receive standard of care during hospital stay.

Best Practice

Bright White Light Therapy

Survey Administration

Shelly Brown, MS, APRN-CNS

This trial investigates how well bright white light therapy works in improving sleep, fatigue, distress, depression, and anxiety, side effects that are often experienced during an intense leukemia treatment regimen, in hospitalized leukemia patients. Bright white light therapy may help to control these symptoms, and information from this study may help doctors and nurses learn more about methods for decreasing these symptoms.

PRIMARY OBJECTIVE:

I. To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.

SECONDARY OBJECTIVES:

I. To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.

I. To assess the efficacy of BWLT on anxiety in patients diagnosed with leukemia during their hospitalization.

III. To assess the efficacy of BWLT on depression in patients diagnosed with leukemia during their hospitalization.

IV. To assess the efficacy of BWLT on distress in patients diagnosed with leukemia during their hospitalization.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive BWLT over 30 minutes in addition to standard of care daily during hospital stay.

GROUP II: Patients receive standard of care during hospital stay.

Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients

The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient

Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue. Will fit a mixed model of fatigue as a function of time and group.

Will be assessed by PROMIS-Sleep Disturbance. Will fit a mixed model.

Will be assessed by General Anxiety Disorder-7. Will fit a mixed model.

Will be assessed by Patient Health Questionnaire Depression Scale. Will fit a mixed model.

Will be assessed by Distress Thermometer. Will fit a mixed model.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Decitabine

Antimetabolites

Enzyme Inhibitors

PART I: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PART II: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 and decitabine IV over 30-60 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tegavivint

Tapan M Kadia

This phase I trial is to find out the best dose and side effects of tegavivint in treating patients with leukemia that has come back (relapsed) or does not response to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint in combination with decitabine may help control the disease.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint in patients with relapsed and refractory acute myeloid leukemia (AML). (Phase I dose escalation) II. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint combined with decitabine in patients with relapsed and refractory acute myeloid leukemia (AML). (Combination cohort)

SECONDARY OBJECTIVES:

I. To assess the safety profile of tegavivint as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Phase I dose escalation) II. To explore the efficacy (complete remission \[CR\], complete remission without blood count recovery \[CRi\], or partial remission \[PR\], of tegavivint as a single-agent in patients with relapsed/refractory (R/R) AML. (Phase I dose escalation) III. To assess overall survival (OS), and disease-free survival (DFS) in patients with R/R AML treated with tegavivint. (Phase I dose escalation) IV. To assess the duration of disease control defined as first date of disease control identified (either CR/CRi, PR or SD) until the date of progression. (Phase I dose escalation) V. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint. (Phase I dose escalation) VI. To assess the safety profile of tegavivint in combination with decitabine as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Combination cohort) VII. To explore the efficacy (complete response \[CR\], complete response without blood count recovery \[CRi\], or partial response \[PR\], of tegavivint in combination with decitabine in patients with R/R AML. (Combination cohort) VIII. To assess overall survival (OS), and disease free survival (DFS) in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort) IX. To assess the duration of disease control defined as first date of disease control identified (either CR/ CRi, PR or SD) until the date of progression. (Combination cohort) X. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort)

OUTLINE: This is a dose-escalation study.

PART I: Patients receive tegavivint intravenously (IV) over 4 hours on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PART II: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 and decitabine IV over 30-60 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Tegavivint for the Treatment of Relapsed or Refractory Leukemia

Phase I Study of Tegavivint (BC-2059) in Patients With Relapsed and Refractory Leukemias

Adverse events will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.

Response rate will be estimated alone with 95% confidence interval.

Will be estimated using the Kaplan-Meier method.

M.D. Anderson Cancer Center

Heart and Blood Diseases

Immune System Diseases

Skin and Connective Tissue Diseases

Heart Failure

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Osteosarcoma

Lymphoma

Cardiomyopathies

Hodgkin Disease

Leukemia, Lymphoid

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Disease Attributes

Heart Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Hodgkin Lymphoma

Soft Tissue Sarcoma

Cardiotonic Agents

Dexrazoxane

Razoxane

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.

Assessment of Therapy Complications

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Site Public Contact

Smita Bhatia

Alexandra M. Walsh

Holly E. Pariury

David L. Becton

Saro H. Armenian

Laura A. Campbell

Jay Michael S. Balagtas

William D. Roberts

Nina S. Kadan-Lottick

Emad K. Salman

Ramamoorthy Nagasubramanian

Dana A. Obzut

Narayana Gowda

Lillian R. Meacham

Wade T. Kyono

Jennifer L. Reichek

Rebecca E. McFall

Jaime M. Libes

Craig Lotterman

Eric C. Larsen

Jason M. Fixler

Kenneth J. Cohen

Lynda M. Vrooman

Adonis N. Lorenzana

Anderson (Andy) B. Collier

Robert J. Hayashi

Alan K. Ikeda

Michael B. Harris

John F. Kuttesch

Jonathan D. Fish

Angela R. Girvin

Laura E. Hogan

Philip M. Monteleone

Douglas J. Scothorn

Thomas B. Russell

Steven J. Kuerbitz

Rajaram Nagarajan

Rene Y. McNall-Knapp

Janice F. Olson

Susan J. Lindemulder

Gregory E. Halligan

Jennifer J. Greene Welch

Jacqueline M. Kraveka

Nichole L. Bryant

Daniel C. Bowers

Julienne Brackett

Anne-Marie R. Langevin

Jessica L. Heath

Madhu S. Gowda

Douglas S. Hawkins

Judy L. Felgenhauer

Richard L. Tower

Marianne B. Phillips

Douglas R. Strother

Sharon B. Abish

Yvan Samson

Bruno Michon

Luis A. Clavell

Eric J Chow

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana Farber Cancer Institute (DFCI) 95-01 randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm.

II. To determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma patients diagnosed during the same time period, but who did not receive DRZ.

III. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex).

SECONDARY OBJECTIVES:

I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI 95-01 on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms.

II. To determine whether projected quality-adjusted life years (QALY) differed by DRZ status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

III. Determine the longitudinal trajectory of 2-dimensional echocardiographic parameters (focusing on left ventricular \[LV\] function and remodeling/geometric changes that can be reliably re-measured) among patients from time of cancer treatment through subsequent follow-up.

OUTLINE:

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.

Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.

An analytic Markov model will be created and used. Estimates and their 95% confidence will be included to explore the sensitivity of any quality-adjusted life years estimates.

An analytic Markov model will be created and used.

Will utilize generalized linear model-general estimation equation to model the trajectories of echocardiographic biomarker estimates (continuous outcomes) across time. Relevant model shapes will be evaluated, beginning with linear models, but also testing more flexible shapes (e.g., quadratic, cubic, or cubic spline functions with varying numbers of knots) to determine whether non-linear components are needed for fit. Will also examine interactions of dexrazoxane (DRZ) status with the selected functions of time to evaluate for differences in trajectories over time by DRZ status.

National Cancer Institute (NCI)

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients	NCT04597086	Acute Leukemia Recurrent Leuke... Refractory Leuk...	Best Practice Bright White Li... Survey Administ...	-	Ohio State University Comprehensive Cancer Center
Tegavivint for the Treatment of Relapsed or Refractory Leukemia	NCT04874480	Recurrent Leuke... Refractory Leuk...	Decitabine Tegavivint	18 Years -	M.D. Anderson Cancer Center
Tegavivint for the Treatment of Relapsed or Refractory Leukemia	NCT04874480	Recurrent Leuke... Refractory Leuk...	Decitabine Tegavivint	18 Years -	M.D. Anderson Cancer Center
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment	NCT01790152	Hodgkin Lymphom... Leukemia in Rem... Lymphoblastic L... Osteosarcoma Recurrent Leuke... Recurrent Lymph... Recurrent Malig...	Assessment of T... Laboratory Biom... Quality-of-Life... Questionnaire A...	-	Children's Oncology Group
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients	NCT04597086	Acute Leukemia Recurrent Leuke... Refractory Leuk...	Best Practice Bright White Li... Survey Administ...	-	Ohio State University Comprehensive Cancer Center

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