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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:

370533 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
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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 04/16/2021.
Displaying: 10 trials in your specialties ()
View trials across your selected specialties

A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma

  • Status
    Not yet recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Follicular Lymphoma
View Full Trial
INTERVENTION

Drug: Venetoclax, Drug: Obinutuzumab, Drug: CC-486

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

University of Chicago Medical Center, Chicago, Illinois, United States

Brief Summary

This study focuses on finding a safe and tolerable dose for a three-drug regimen that combines venetoclax (Venclexta Ⓡ), CC-486 (also known as oral azacitidine) and obinutuzumab (Gazyva Ⓡ) to treat cancer participants who have minimally pretreated follicular lymphoma and have experienced disease progression despite trying previous cancer therapies. If a safe and tolerable drug dose can be found in the first phase of the study, doctors leading the study will launch a second phase of the study within an expansion cohort. Participants in this expansion cohort will receive the dose established in the first phase of the study to determine the efficacy of the regimen/ established dose. Participants in the expansion cohort will also receive the same study drugs from the first phase of the study, but in a different order/combination (first pairing the two oral drugs, CC-486 and venetoclax, then adding the third drug, obinutuzumab to treatment). The end goal of this research is to establish a new chemotherapy-sparing treatment option for patients with follicular lymphoma that is just as effective (or better) than current standard of care options.

Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Lymphoma, T-Cell
View Full Trial
INTERVENTION

Drug: Azacitidine, Drug: Romidepsin, Drug: Gemcitabine

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

National Cancer Center Hospital, Chuo-ku, Japan

Brief Summary

This study is a multicentric, open-label, randomized phase 3 trial. The study will be conducted in select countries in Europe and South Korea sponsored by LYSARC and in Japan sponsored by Celgene. There will be a combined enrollment target of 86 randomized patients, with approximately 14 randomized patients from Japan. The enrollment to the randomized study will start at European sites in parallel to a safety run-in part in Japan. A safety run-in will be conducted to confirm the tolerability of oral azacitidine at doses of 100 mg and 200 mg QD in Asian patients. Once oral azacitidine at 200 mg QD is confirmed as tolerable, Asian patients from Japan and South Korea will start to be randomized into the main study. Additional patients (non-randomized) are anticipated to enroll to the safety run-in.

Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Relapsed Angioimmunoblastic T-Cell Lymphoma, Refractory Angioimmu...
View Full Trial
INTERVENTION

Drug: Oral azacitidine, Drug: Romidepsin, Drug: Bendamustine, Drug: Gemcitabine

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

The Christie, Manchester, United Kingdom

Brief Summary

This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Previously Untreated Peripheral T-cell Lymphoma
View Full Trial
INTERVENTION

Drug: CC-486 Administration, Drug: CHOP Administration

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

Moffitt Cancer Center, Tampa, Florida, United States

Brief Summary

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.

Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Large B-Cell Diffuse Lymphoma
View Full Trial
INTERVENTION

Drug: Oral azacitidine, Drug: R-ICE

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

Medical University of South Carolina, Charleston, South Carolina, United States

Brief Summary

The purpose of this study is to determine the safety and tolerability of adding oral azacitadine to the chemotherapy combination R-ICE. This study will also look at whether or not disease outcomes improve with the combination.

CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Recurrent Lymphoplasmacytic Lymphoma, Recurrent Mantle Cell Lymph...
View Full Trial
INTERVENTION

Drug: Lenalidomide, Biological: Obinutuzumab, Drug: Oral Azacitidine

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

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Brief Summary

This phase I/Ib trial investigates the side effects of CC-486 and how well it works in combination with lenalidomide and obinutuzumab in treating patients with CD20 positive B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Chemotherapy drugs, such as CC-486, 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. Lenalidomide is a drug that alters the immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Obinutuzumab is a type of antibody therapy that targets and attaches to the CD20 proteins found on follicular lymphoma cells as well as some healthy blood cells. Once attached to the CD20 protein the obinutuzumab is thought to work in different ways, including by helping the immune system destroy the cancer cells and by destroying the cancer cells directly. Giving CC-486 with lenalidomide and obinutuzumab may improve response rates, quality, and duration, and minimize adverse events in patients with B-cell lymphoma.

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

  • Status
    Not yet recruiting
  • Phase
    Phase 1
  • Condition
    Adult T-cell Leukemia/Lymphoma, Extranodal NK-/T-cell Lymphoma, N...
View Full Trial
INTERVENTION

Drug: CC-486 (5-azacitidine), Drug: Duvelisib, Drug: Romidepsin, Drug: Doxorubicin

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

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Brief Summary

Background: T-cell lymphomas (TCLs) are rare cancers. Many types of TCLs do not develop in the lymph nodes but in places like the skin, spleen, and bone marrow. Researchers want to see if a mix of 4 drugs can help people with TCL. Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), duvelisib, and doxorubicin can be used safely in people with TCL. Eligibility: Adults 18 and older with TCL that is newly diagnosed or that returned after or did not respond to standard treatments. Design: Participants will be screened on a separate protocol. They may have a tumor biopsy. Participants will have medical histories, medicine reviews, and physical exams. Their ability to do daily activities will be assessed. They will have blood and urine tests. Participants will take duvelisib and CC-486 (5-azacitidine) by mouth. They will get romidepsin and doxorubicin by intravenous infusion. They will take the drugs for up to eight 21-day cycles. They will keep a medicine diary. Participants will have a bone marrow aspiration and/or biopsy. Bone marrow will be taken through a needle inserted in the hip. Participants will have tumor imaging scans. Some may have a brain MRI and lumbar puncture. Some may have skin assessments. Participants will give blood, saliva, and tumor samples for research. Participants will have a safety visit 30 days after treatment ends. Then they will have follow-up visits every 60 days for 6 months, then every 90 days for 2 years, and then every 6 months for 2 years. Then they will have yearly visits until their disease gets worse or they start a new treatment....

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Leukemia, Metastatic Breast Cancer, Hematological Neoplasms, Non-...
View Full Trial
INTERVENTION

Drug: CC-486, Drug: Vidaza

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

Scottsdale Healthcare Research Institute, Scottsdale, Arizona, United States

Brief Summary

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

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
    Completed
  • Phase
    Phase 1
  • Condition
    Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
View Full Trial
INTERVENTION

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

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

Phase 1 Study of CC-486 in Japanese Subjects With Hematological Neoplasms

  • Status
    Other
  • Phase
    Phase 1
  • Condition
    Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia, Multiple...
View Full Trial
INTERVENTION

Drug: Oral azacitidine

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

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Brief Summary

To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment schedules in Japanese subjects with hematological neoplasms