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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:

354,475 studies
in
216 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/03/2020.
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Clinical Trials of Interest

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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 12/03/2020.
Displaying: 580 trials in your specialties ()
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Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Hematologic Malignancies
View Full Trial
INTERVENTION

Drug: Fludarabine, Drug: Cytoxan, Radiation: Total Body Irradiation, Procedure: Allogeneic Blood or Marrow Transplant, Procedure: Peripheral Blood Stem Cell Transplant, Drug: Mycophenolate Mofetil, Drug: Sirolimus, Drug: Tacrolimus

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Brief Summary

If transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT) to the use of such donors, investigating up to several postgrafting immunosuppression regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus into this postgrafting immunosuppression regimen. The primary goal for phase 1 is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month probability of survival without having had acute grade III- IV GVHD or graft failure.

Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: Venetoclax

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

HelsinkiUCH, Helsinki, Uusimaa, Finland

Brief Summary

This is a multi center two-stage, two-arm, open label phase II study of venetoclax in combination with azacytidine in acute myeloid leukemia patients selected for therapy with ex vivo venetoclax sensitivity screening. This study will characterize the usability of ex vivo drug sensitivity testing for patient selection for selecting the responsive patients for venetoclax therapy. The exploratory study will aim to find novel combinations for overcoming resistance as well as finding/validating biomarkers for both sensitivity and resistance.

Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

  • Status
    Recruiting
  • Phase
    Early Phase 1
  • Condition
    Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leuke...
View Full Trial
INTERVENTION

Drug: INA03 administration

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Institut Paoli-Calmettes, Marseille, Bouches-du Rhône, France

Brief Summary

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Newly Diagnosed Secondary or High Risk AML
View Full Trial
INTERVENTION

Drug: CPX-351

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Institut Català D'Oncologia-Hospital Germans Trias I Pujol, Badalona, Spain

Brief Summary

This protocol corresponds to a prospective, multicentre, open label, phase II study designed to evaluate the efficacy of CPX-351 in elderly patients with secondary or high-risk AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a single arm group. Patients will be enrolled at diagnosis to follow the treatment arm. After that will start induction chemotherapy with CPX-351 regimen (14 days maximum screening period). Once a patient have been evaluated for response and recovered from major complications, he/she will start second course (consolidation 1), unless the bone marrow and peripheral blood assessment is showing less than a complete response, then a second induction may be offered. If a CR or CRi is obtained after the second induction course, patients will start the third course after a rest and recovery period. Patients aged between 60 and 65 years old are recommended to undergo an allo-SCT after first consolidation if they are considered fit for this procedure and they have a full matched related or unrelated donor. Patients aged between 65 and 70 years old can be proposed for an allo-SCT in CR/CRi if they have a composite HSCT co-morbidity index /age less than 4 and a suitable fully matched related donor. In patients over 70 years old, an allo-SCT in first CR should be avoided although the decision should be taken on an individual basis. Patients with CR/CRi who are not considered for an allo-SCT, will follow 6 maintenance cycles with modified courses of CPX-351 schedule. Patients showing unacceptable toxicity along all therapeutic phases that, in consideration of the investigator, will be prematurely discontinued. All patients will be followed-up for survival. The study will be analyzed on an intention to treat basis. Bone marrow and response assessments will be done after each induction and consolidation course, and every 3 months during the first 12 months after starting maintenance therapy. Patients will be followed-up for a minimum period of 1 year after the enrolment of the last patient. Additionally, after the end of the trial, patients will be followed-up for 2 years in order to verify survival and the evolution of the disease. Study design allows a maximum of 59 patients.

Decitabine and Talazoparib in Untreated AML and R/R AML

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: Decitabine, Drug: talazoparib

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

Brief Summary

The purpose of this study is to find the best way to combine a new chemotherapy drug with one that is already in use to treat AML. The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA is allowing the use of talazoparib for the purposes of this study. Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as well as off label for AML. Lab work suggests that talazoparib will increase the effects of decitabine in leukemia cells. Investigators hope that treating patients with decitabine and talazoparib together will be more successful that treating patients with decitabine alone. This study has two parts. The purpose of part one the study is to find out the best doses of decitabine and talazoparib to use when they are given together to treat AML. The purpose of part two is to see how well the drugs work together to treat AML. All participants in the study will be treated with decitabine and talazoparib. Part one of the study will include as few as two people and as many as 36 people to find the best dose levels of the study drugs. Part one will begin enrolling first. Part two of the study will not start until the Part one of the study is complete. Participants will be told which part of the study they may be enrolled in. Part two of the study may include as few as 79 people and as many as 135 people. Part two includes three separate arms. Participants enrolled in Part two of the study, will be assigned to one of the three arms below in order to test the success rate of the study drug dose determined by Part one: - Arm A will enroll adult patients with AML who are thought not to be likely to tolerate or respond to standard chemotherapy; - Arm B will enroll adult patients with AML that has not responded to previous treatment or has come back after responding to previous treatment; - Arm C will enroll adult patients previously treated with a DNA methyltransferase inhibitor (decitabine, azacitidine or guadecitabine). This is a multi-center study. Up to 171 people may take part in this study globally.

Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)

  • Status
    Active, not recruiting
  • Phase
    Phase 4
  • Condition
    Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: Decitabine, Drug: Daunorubicin, Cytarabine, Drug: Mitoxantrone, Cytarabine, Drug: Aclacinomycin, Cytarabine

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

First Hospital of Jilin University, Changchun, Jilin, China

Brief Summary

Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is the standard consolidation therapy for these patients with a 5-year overall survival approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation, maintenance therapy is performed with conventional chemotherapy with a 5-year overall survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine was also reported by several studies. In this study, the investigators plan to carry out a prospective, multicenter, randomized, controlled trail to compare decitabine versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results of this trial may optimize the treatment for AML patients with t(8;21) in the setting of intermediate dose cytarabine consolidation.

Study of DSP-7888 in Patients With Myelodysplastic Syndrome

  • Status
    Active, not recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Myelodysplastic Syndrome
View Full Trial
INTERVENTION

Drug: DSP-7888

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Japanese Red Cross Narita Hospital, Narita, Chiba, Japan

Brief Summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist.

A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: LB-100

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Brief Summary

The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors. In this study, LB-100 will be administered as an intravenous infusion over 120 minutes. This study will be conducted in 2 phases. In phase Ib, escalating doses of LB-100 will be administered to patients to study the safety and to determine a safe dose of LB-100. In phase 2, patients will be administered LB-100 at the dose that was found to be safe in phase Ib. The efficacy (benefits) and safety of LB-100 will be determined in this phase of the study.

SGI-110 and Donor Lymphocyte Infusions (DLI) After Allogeneic Stem Cell Transplantation

  • Status
    Not yet recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes, Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: Guadecitabine

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hôpital Necker, Paris, France

Brief Summary

High risk MDS (Myelodysplastic Syndrome) patients will be treated with SGI-110 after Allogeneic Stem Cell Transplantation in the hypothesis that SGI-110 maintenance given early after HSCT can prevent relapse without increasing non-relapse mortality translating in an improved disease-free survival.

CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Myeloid Neoplasm, Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Drug: Liposome-encapsulated Daunorubicin-Cytarabine, Drug: Cladribine, Drug: Cytarabine, Biological: Recombinant Granulocyte Colony-Stimulating Factor, Drug: Mitoxantrone

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Brief Summary

This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, cladribine, cytarabine, G-CSF, and mitoxantrone, 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 CPX-351 or the CLAG-M regimen at doses typically used for medically-fit patients with acute myeloid leukemia may work better than reduced doses of CPX-351 in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms.