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Hematologic Neoplasms clinical trials

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NCT ID: NCT05333913 Recruiting - Clinical trials for Functional Iron Deficiency

Prevalence of FID and QoL in Patients With Oncological and With Haematological Malignancies

Start date: February 7, 2022
Phase:
Study type: Observational

Prospective single-center observational study assessing prevalence of FID (Laboratory work-up) and Quality of Life (Questionnaire) in adult patients with oncological and with haematological malignancies within four weeks prior to disease-directed therapy.

NCT ID: NCT05327023 Recruiting - Clinical trials for Hematologic Neoplasms

Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

Start date: May 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk. Objective: To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers. Eligibility: Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed. Design: Participants will be screened with: Physical exam Blood and urine tests Spinal tap Eye exam Dental exam Heart and lung tests Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed. Bone marrow aspiration and biopsy Some screening tests will be repeated during the study. Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant. Participants will have periodic follow-up visits for 5 years. Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research. Participation will last for 5 years....

NCT ID: NCT05323409 Recruiting - Breast Cancer Clinical Trials

Improving Comprehensive Care of Cancer Patients

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Cancer survivors have unique healthcare needs including risk for serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% have at least one comorbid chronic condition in addition to cancer. Comorbidities pose significant challenges to the delivery of quality cancer care because they adversely affect and are affected by cancer treatment. Medically underserved patients have the highest burden of multiple chronic conditions and are at increased risk for poor outcomes during and after cancer treatment. As medically underserved cancer patients may lack healthcare knowledge and access to supportive care, their health outcomes and care transitions might be improved by enhancing communication and collaboration between their oncologists and primary care providers (PCPs). This study tests and evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care) in the largest safety-net healthcare system in Houston, Texas. Three-hundred newly diagnosed breast, GI, and hematological cancer patients who are being treated with curative intent and who have comorbidities requiring ongoing management during cancer treatment will complete baseline surveys and be randomized to either OPTIMISE or Usual Medical Care (UMC). Patients receiving UMC will receive their cancer treatment, as directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits with their oncologist based on national guidelines. Patients in OPTIMISE will 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication and continuity of care; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance facilitated by a structured communication and referral process; 3) receive a survivorship care plan (SCP) at the end of treatment that incorporates comorbidity management; and, 4) receive a risk-stratified shared care model of post-treatment surveillance where one or more routine oncologist follow-up visits is replaced by a PCP visit. Aim 1a evaluates the impact of OPTIMISE on patient chronic disease self-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores the effects of OPTIMISE on healthcare use and patient unmet needs during and after active cancer treatment. Aim 2 examines the effects of OPTIMISE on oncologist and PCP attitudes and coordination of care. Aim 3 seeks to elucidate patient- and system-level factors that may influence implementation outcomes. OPTIMISE shifts the timing of thinking about survivorship to point of diagnosis and seeks to develop a clinical infrastructure to support continuity of care from cancer diagnosis through post-treatment survivorship. If found effective, OPTIMISE could be expanded to other cancers, igniting a potentially rich area of research. It may also have significant downstream impact in other medical settings by enhancing care transitions from specialty to primary care.

NCT ID: NCT05306509 Recruiting - Solid Tumor Clinical Trials

Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology

NiCE
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.

NCT ID: NCT05298930 Recruiting - Clinical trials for Myelodysplastic Syndromes

Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation

EVAADE
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

Allogeneic haematopoietic stem cell transplantation (aHSCT) is the only curative treatment for many paediatric and young adult haematological pathologies (acute leukaemia, myelodysplastic syndromes haemoglobinopathies, bone narrow aplasia, severe combined immunodeficiency). Despite the major therapeutic progress made over the last 50 years, particularly in terms of supportive care, post-transplant morbidity and mortality remain high. Infectious complications, whose incidence varies between 30 and 60%, are the first cause of mortality in the immediate post-transplant period. In order to protect the patient from the occurence of severe infectious episodes, aHSCT must be performed in a highly protected environment (positive pressure chambers). This has consequences for the experience and impact of hospitalization on the patient and family. This is particularly true in pediatrics, with children, adolescents or young adults, where it is not only the patient's quality of life that is at stake, but also his emotional and psychomotor development. In this specific population, prolonged hospitalization (at least 6 weeks) in a sterile room will be responsible for physical deconditioning accompanied by a decrease in muscle mass. Patients often experience an deteriorated quality of life. Today, the benefits of physical activity (PA) during and after cancer treatment have been widely demonstrated. The objective of the study is to assess the feasibility of an adapted physical activity program during the isolation phase for achieving aHSCT in children, adolescents and young adults. This is a prospective, interventional, monocentric cohort study conducted at the institute of Paediatric Haematology and Oncology in Lyon. The intervention will take place during the isolation phase and will be based on an adapted physical activity (APA) program defined at inclusion, integrating supervised sessions with an APA teacher, as well as autonomous sessions performed by means of a connected bike in the sterile room. The program will be individualized according to age, aerobic capacities, and PA preferences. Sessions will also be tailored to the biological, psychological, and social parameters of patients. The total duration of the intervention is 3 months. To date, no PA studies have been performed in patients under 21 years old requiring aHSCT during the sterile isolation phase. EVAADE will therefore be the first study in this population to offer an innovative procedure with a connected device.

NCT ID: NCT05293912 Recruiting - Lymphoma Clinical Trials

SG2501 Safety Study in Subjects With Relapsed or Refractory Hematological Malignancies and Lymphoma.

Start date: August 3, 2022
Phase: Phase 1
Study type: Interventional

This is a phase Ia/Ib, first-in-Human, open-Label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SG2501 in subjects with relapsed or refractory hematological malignancies and lymphoma.

NCT ID: NCT05292664 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia, in Relapse

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. - Venetoclax - Azacitidine - Cytarabine - Methotrexate - Hydrocortisone - Leucovorin - Dexamethasone - Vincristine - Doxorubicin - Dexrazoxane - Calaspargase pegol - Hydrocortisone

NCT ID: NCT05290545 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT

Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.

NCT ID: NCT05284032 Recruiting - Clinical trials for Hematologic Malignancy

A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)

Start date: November 29, 2022
Phase: Early Phase 1
Study type: Interventional

Some of the treatments for cancer can cause platelets (the part of the blood that helps with clotting) to decrease. If they are too low, then clinicians may recommend a transfusion (getting platelets from another person added to someone else's body). This usually works to increase the person's platelets to a healthy level, but sometimes it doesn't work. This is called platelet refractoriness. This study is trying to find out whether isatuximab (the study drug) may help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.

NCT ID: NCT05270096 Recruiting - Clinical trials for Relapsed Hematologic Malignancy

International Leukemia Target Board

iLTB
Start date: December 31, 2022
Phase:
Study type: Observational

The iLTB is a proof-of-concept initiative for children with r/r hematological malignancies, in which available treatment options will be prioritized by actionable events in a harmonized and uniform setting across Europe by a team of biologists, bio-statisticians, bio-informaticians, disease experts, geneticists, flow-experts, clinical trial physicians and also the treating physician. The iLTB will discuss molecular (genetic lesions), immunophenotypic/surface antigen markers information and, if available, drug response profiles to prioritize these events taking into account the treatment history and treatment intention (bridging to hematopoietic stem cell transplanation/CAR-T or palliative) of each patient followed by a registry to monitor how often iLTB advice has been followed, which other therapy was chosen (off-label, compassionate use) and what the patient outcome is at an aggregated level. As such the iLTB is non-interventional as it mainly provides advice and registers data on patients discussed in the iLTB.