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About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

342,868 studies
in
216 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/04/2020.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/04/2020.
Displaying: 388 trials in your specialties ()
View trials across your selected specialties

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Refractory Anemia With Excess Blasts, MDS, RAEB, Myelodysplastic ...
View Full Trial
INTERVENTION

Drug: rigosertib, Drug: Any approved or standard-of-care therapy, Drug: best supportive care (BSC), Drug: best supportive care (BSC)

Eligibility
  • Ages: 18 to 81 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

UC San Diego Moores Cancer Center, La Jolla, California, United States

Brief Summary

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Acute Mye...
View Full Trial
INTERVENTION

Drug: Azacitidine, Drug: Ascorbic acid

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Brief Summary

The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in term may help to improve counts and symptoms, related to Myelodysplastic Syndromes and Acute Myeloid Leukemia. This combination is specific to individuals who carry this mutation.

A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: Pracinostat, Drug: Azacitidine

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

City of Hope, Duarte, California, United States

Brief Summary

This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination with azacitidine in patients with IPSS-R high and very high risk MDS who are previously untreated with HMAs. Enrollment in this study will be limited to high/very high risk MDS because this group represents the highest unmet need, with median survival of less than 18 months. Stage 1a will be conducted as an open-label single arm in up to 40 subjects to assess if this regimen with a lower pracinostat dose results in a discontinuation rate that meets a predefined threshold and in efficacy that justifies expansion of enrollment into Stage 1b. A discontinuation rate of approximately ≤10% in Stage 1a, a rate comparable to that observed with azacitidine alone in study MEI-003, supports expansion into Stage 1b. Stage 1b will be conducted as expansion of stage 1a. Approximately 20 additional subjects will be enrolled. Study drugs should be continued until disease progression or intolerable toxicity. It is important to note that the median time to achieving a response with azacitidine alone is 4 to 5 months. Furthermore, the median time to achieving a CR in study MEI-003 was 4 cycles. Therefore, early (<6 months) discontinuation of trial therapy for 'no response' should be avoided. The Medical Monitor should be contacted prior to discontinuing a subject from the study to discuss the rationale for discontinuation.

Azacitidine and Pembrolizumab in Treating Patients With Myelodysplastic Syndrome

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndrome, High Risk Myelodysplastic Syndrome, IPS...
View Full Trial
INTERVENTION

Drug: Azacitidine, Biological: Pembrolizumab

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

M D Anderson Cancer Center, Houston, Texas, United States

Brief Summary

This phase II trial studies the side effects of azacitidine and pembrolizumab and to see how well they work in treating patients with myelodysplastic syndrome. Azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and pembrolizumab may work better at treating myelodysplastic syndrome.

A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma

  • Status
    Active, not recruiting
  • Phase
    Phase 1
  • Condition
    Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
View Full Trial
INTERVENTION

Drug: Rituximab, Drug: cyclophosphamide, Drug: Vincristine, Drug: Prednisone, Drug: Oral Azacitidine

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Moffitt Cancer Center, Tampa, Florida, United States

Brief Summary

The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more) previously untreated DLBCL or Grade 3B FL. Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria.

Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    FLT3 Internal Tandem Duplication, Fibroblast Growth Factor Basic ...
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INTERVENTION

Drug: Azacitidine, Other: Laboratory Biomarker Analysis, Drug: Nintedanib

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Northwestern University, Chicago, Illinois, United States

Brief Summary

The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

  • Status
    Active, not recruiting
  • Phase
    Phase 3
  • Condition
    Acute Myeloid Leukemia (AML)
View Full Trial
INTERVENTION

Drug: Azacitidine, Drug: Venetoclax, Drug: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

City of Hope /ID# 154105, Duarte, California, United States

Brief Summary

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Leukemia, Erythroblastic, Acute, Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: 5-Azacytidine, Drug: Fludarabine, Drug: Melphalan, Drug: Alemtuzumab, Radiation: Total Body Irradiation

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Weill Cornell Medical College, New York, New York, United States

Brief Summary

The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in complete remission (CR).

Vidaza and Valproic Acid Post Allogeneic Transplant for High Risk AML and MDS

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Acute Myelogenous Leukemia AML, Myelodysplastic Syndrome MDS
View Full Trial
INTERVENTION

Drug: Vidaza and Valproic Acid

Eligibility
  • Ages: 2 to 89 Years (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Loyola University Cardinal Bernardin Cancer Center, Maywood, Illinois, United States

Brief Summary

Phase II trial combining azacitidine with valproic acid as maintenance therapy post allogeneic stem cell transplantation in patients with high-risk MDS/AML. We hypothesize that adding valproic acid to azacitidine will improve outcomes via both direct anti-tumor and immunologically mediated antitumor response with alloreactive donor lymphocytes, having an additive effect and extending 1 year survival in patient with high-risk AML/MDS after hematopoietic stem cell transplant. Based on aforementioned data from the US Department of Health and Human Services, standard 1 year survival for AML after stem cell transplant is near 40%. We hypothesize that valproic acid and azacitidine will prolong survival, with a 1 year survival goal of 60%. In addition to assessing for 1 year survival, we will have secondary objectives of assessing progression-free survival, relapse, and toxicity. The primary toxicity endpoint from this will be cytopenias and infections.

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Acute Myeloid Leukemia Arising From Previous Myelodysplastic Synd...
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INTERVENTION

Drug: Azacitidine, Drug: Cytarabine, Drug: Fludarabine Phosphate, Drug: Methotrexate, Drug: Pevonedistat, Drug: Therapeutic Hydrocortisone

Eligibility
  • Ages: 1 to 21 Month (Child, Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Brief Summary

This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.