A Phase 2 Study of Venetoclax in Relapsed Classic or Variant Hairy Cell Leukemia
This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
NCT06311227 — Recurrent Hairy Cell Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/recurrent-hairy-cell-leukemia/NCT06311227/
A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia
The percentages of participants in clinical studies haven't always been perfectly representative of a particular group. This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.
NCT05859932 — Hairy Cell Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/hairy-cell-leukemia/NCT05859932/
A Single Arm Phase II Pilot Study of Low Dose Vemurafenib Plus Rituximab in the Front-line and Relapsed/Refractory Treatment of Hairy Cell Leukemia
The current standard-of-care for Hairy Cell Leukemia involves chemotherapy, with agents such as cladribine or pentostatin. Chemotherapy is associated with infection, low blood counts and predisposition to future cancers. This study tests a new yet previously validated drug combination for the treatment of hairy cell leukemia. The treatment involves 8 weeks of treatment with an oral drug called vemurafenib and 8 doses of an intravenous medication called rituximab. The goal of this study is to see whether this treatment is better tolerated and more effective than the currently used treatment in this disease. In addition, this study uses a lower dose of vemurafenib than previous studies have used, with the goal of minimizing side effects from this medication.
NCT05388123 — Hairy Cell Leukemia
Status: Recruiting
http://inclinicaltrials.com/hairy-cell-leukemia/NCT05388123/
Phase 2 Trial for Binimetinib for Patients With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
Background: Most people with hairy cell leukemia have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. We found that in hairy cell leukemia, when BRAF is not mutated, the MEK gene frequently is. Binimetinib is a MEK inhibitor which targets MEK. It is important to determine if this drug can be a good treatment option in those who cannot benefit treatment with BRAF inhibitors. Objective: To see if binimetinib is an effective treatment for hairy cell leukemia that does not have a BRAF mutation. Eligibility: People ages 18 and older with hairy cell leukemia without a mutation in the BRAF gene and whose disease either did not respond to treatment or came back after treatment Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Lung and heart tests - Eye exam - Bone marrow biopsy: A needle will be injected through the participant s skin into the bone to remove a sample of marrow. - CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They might receive a contrast agent by vein. Before they start treatment, participants will have an abdominal ultrasound, pulmonary function tests, and exercise stress tests. Participants will take binimetinib by mouth twice daily in 28-day cycles. They will keep a medication diary. Participants will have at least one visit before every cycle. Visits will include repeats of some screening tests. Participants may continue treatment as long as their disease does not get worse and they do not have bad side effects. About a month after their last dose of treatment, participants will have a follow-up visit. They will then have visits once a year. ...
NCT04322383 — Hairy Cell Leukemia
Status: Recruiting
http://inclinicaltrials.com/hairy-cell-leukemia/NCT04322383/
An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia
NCT03501615 — Relapsed/Refractory Hairy Cell Leukemia
Status: Approved for marketing
http://inclinicaltrials.com/relapsed-refractory-hairy-cell-leukemia/NCT03501615/
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients. However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse. Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.
NCT02883946 — Hairy-cell Leukemia
Status: Completed
http://inclinicaltrials.com/hairy-cell-leukemia/NCT02883946/
Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 1,000 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.
NCT02560883 — Leukemia, Other
Status: Recruiting
http://inclinicaltrials.com/leukemia-other/NCT02560883/
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment. They have to be untreated so far or may be pretreated with alpha-interferon.
NCT02131753 — Hairy Cell Leukemia
Status: Recruiting
http://inclinicaltrials.com/hairy-cell-leukemia/NCT02131753/
A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) for Treatment of Relapsed Hairy Cell Leukemia
This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT01841723 — Hairy Cell Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/hairy-cell-leukemia/NCT01841723/
A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia
Background: - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.
NCT01829711 — Leukemia, Hairy Cell
Status: Completed
http://inclinicaltrials.com/leukemia-hairy-cell/NCT01829711/