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Cytopenia clinical trials

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NCT ID: NCT05236764 Recruiting - Clinical trials for Myelodysplastic Syndromes

Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion

HAPLOTAB
Start date: December 6, 2023
Phase: N/A
Study type: Interventional

Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. This process is expected to substantially decrease the risk of GvHD thus allowing for the elimination of immunosuppressive therapy post-transplant. The study will use blood stem/progenitor cells collected from the peripheral blood of parent or other half-matched (haploidentical) family member donor. The procedure will be performed using CliniMACS® TCRα/β-Biotin System which is considered investigational.

NCT ID: NCT05030441 Recruiting - Clinical trials for Clonal Cytopenia of Undetermined Significance

Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter study exploring the efficacy of ivosidenib in patients with clonal cytopenia of undetermined significance (CCUS) with mutations in IDH1. The purpose is to establish proof of principle that ivosidenib is well-tolerated and potentially efficacious in improving blood count abnormalities in these patients. The study will also be offered in a decentralized, remote structure to patients.

NCT ID: NCT04902833 Recruiting - Clinical trials for Acute Myeloid Leukemia

Acquired Pyruvate Kinase Deficiency In Clonal Myeloid Neoplasms

Start date: February 1, 2022
Phase:
Study type: Observational

This cross-sectional prevalence assessment study involves a single blood draw in specific patient populations to assess for enzymatic and genomic evidence for acquired pyruvate kinase deficiency.

NCT ID: NCT04873102 Recruiting - Cirrhosis, Liver Clinical Trials

Danazol for Treatment of Cytopenias in Patients With Cirrhosis

Start date: May 2023
Phase: Phase 2
Study type: Interventional

This is a phase II pilot study designed to assess the safety and efficacy of danazol for treatment of cytopenias in patients with CPC A/B cirrhosis. Subjects with or without telomere mutations and/or shortened telomeres will be treated with danazol 600 mg per day by mouth for a duration of 24 months. The goal will be to treat a total of 10 patients.

NCT ID: NCT04741945 Recruiting - Cytopenia Clinical Trials

Repurposing Metformin as a Leukemia-preventive Drug in CCUS and LR-MDS

Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

This is a single-arm pilot study of the feasibility and safety of metformin in patients with clonal cytopenia of undetermined significance (CCUS) or lower-risk myelodysplastic neoplasms (LR-MDS).

NCT ID: NCT04419649 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.

NCT ID: NCT04102423 Recruiting - Clinical trials for Clonal Cytopenia of Undetermined Significance

CHIP/CCUS Natural History Protocol

Start date: March 3, 2020
Phase:
Study type: Observational

Background: Clonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one or more blood cell types is lower than it should be and is associated with a change in their DNA. Researchers want to learn more about how CHIP and CCUS progress. Objective: To examine the natural history of people in a study of CHIP and CCUS to (1) verify the association of myeloid somatic mutations with atherosclerosis and blood cancers, and (2) find new potential clinical associations. Eligibility: Adults 18 and older with CHIP with a somatic pathogenic variant associated with blood cancers. Adults with CCUS are also needed. Design: Potential participants will be screened with gene testing. For this, they will give a blood sample. They will also be enrolled in NHLBI screening protocol #97-H-0041. Those who pass this screening will visit the NIH Clinical Center for more screening tests. For this, they will give a blood sample. They will have a physical exam. They will give their medical history. They may give a urine sample. Those with CCUS will have bone marrow taken. Eligible participants will give blood and urine samples. Their heart activity will be monitored and tested. The arteries in their neck will be assessed using ultrasound. They will have liver and heart scans. They will have a bone mineral density scan. They will have lung function tests. They will have the inside of their cheek swabbed or have a skin punch biopsy. They will have the option to have advanced scans done of their heart and full body but this is not required. Participants will have yearly follow-up visits for 10 years. They will repeat the above procedures every 1-3 years depending on the procedure.

NCT ID: NCT04070612 Completed - Cytopenia Clinical Trials

National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.

BIOCEREVANCE
Start date: April 4, 2007
Phase:
Study type: Observational

This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.

NCT ID: NCT03733249 Terminated - Clinical trials for Myelodysplastic Syndromes

Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a long-term follow up study evaluating the safety of BPX-501 T cells (rivogenlecleucel) and infused in pediatric patients previously enrolled on the BP-004 study.

NCT ID: NCT03682029 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

EVITA
Start date: November 21, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this multi-centre, randomized, placebo-controlled, double-blind phase II study is to investigate if oral vitamin C may change the biology of low-risk myeloid malignancies; i.e., clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)-0/1 by reversing the epigenetic changes characteristic of these disease entities. The epigenetic regulator TET2 is the gene most often affected in CCUS. Preclinical studies have shown that active demethylation by the TET enzymes is dependent on vitamin C, and the investigators and collaborators have shown that plasma vitamin C levels are exceedingly low in hematological cancer patients but are easily corrected by oral vitamin C. This study is part of an array of EVITA studies aimed at clarifying whether the standard of care of patients with myeloid malignancies should be changed and oral vitamin C supplement added to the treatment recommendations.