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A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd)followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) TherapyDirected Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd)

Principal Investigator:

Ran Reshef, MD

Contact Number:

212-342-5162

NCT Number:

NCT04923893

Population:

Adult

Phase:

III

The purpose of this study is to see if Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by cilta-cel is safe and useful for treating patients with newly diagnosed Multiple Myeloma, as compared with the use of VRd followed by Lenalidomide and Dexamethasone (Rd) therapy. Cilta-cel is a CAR-T cell therapy. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become cilta-cel and used to treat your multiple myeloma. After pre-randomization therapy you will be assigned randomly into either Arm A or Arm B of the study. If...
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with AcuteMyeloid Leukemia (AML) (VIALE-T)

Principal Investigator:

Amer Assal, MD

Contact Number:

212-342-5162

NCT Number:

NCT04161885

Population:

Adult

Phase:

III

The purpose of this study is to evaluate the safety and efficacy of venetoclax and azacitidine compared to Best Supportive Care in patients with Acute Myeloid Leukemia (AML) after an allogeneic stem cell transplant (SCT). This is the first randomized study comparing venetoclax in combination with azacitidine versus best supportive care in subjects with AML who have just received an allogeneic stem cell transplant. Randomization is a process in which the computer makes a decision based upon chance that decides which study treatment you will be assigned. Best supportive care includes a few...
An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT03336333

Population:

Adult

Phase:

III

The purpose of this study is to compare the effects, good or bad, of the experimental drug BGB-3111, versus a known standard treatment called bendamustine plus rituximab (B+R) on you and your chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) to find out which is better. In this study you will receive either BGB-3111 or the standard chemotherapy treatment bendamustine plus rituximab (B+R). Are you Eligible? (Inclusion Criteria) To be eligible for this trial, participants must: Do you have a diagnosis of CLL or SLL? Are you at least 18 years old? Do you have adequate organ...
A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05232916

Population:

Adult

Phase:

III

The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a study medication called GP2 and the FDA-approved medication, granulocyte-macrophage colony-stimulating factor (GM-CSF) or sargramostim (Leukine®). It is thought that this medication will work by helping your immune system identify and...
DFCI 16-001, Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children andAdolescents

Principal Investigator:

Justine Kahn, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03020030

Population:

Pediatrics

Phase:

III

This is a Harvard Dana Farber Cancer Institute treatment protocol for children and adolescents that are newly diagnosed with acute lymphoblastic leukemia. ALL is a cancer of the blood. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all patients with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are...
Double-blind, randomized, placebo-controlled, prospective Phase III study evaluating efficacy and safety of Panzyga in Primary Infection Prophylaxis in patients with Chronic Lymphocytic Leukemia (“PRO-SID” study)

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04502030

Population:

Adult

Phase:

III

This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). The immune system is a bodily system that protects the body from foreign substances, infection agents, cells, and tissues. When the immune system does not work properly, it´s called immunodeficiency. This can be caused by hematological malignancies (forms of cancer that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system) like chronic lymphocytic leukemia (CLL). That´...
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT03937635

Population:

Adult

Phase:

III

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups. Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at...
EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator's Choice ofEndocrine Therapy, in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advancedor Metastatic Breast Cancer Previously Treated with Endocrine Therapy

Principal Investigator:

Meghna S Trivedi, MD

Contact Number:

212-342-5162

NCT Number:

NCT04975308

Population:

Adult

Phase:

III

This study is being done to see how safe an investigational drug, LY3484356 is and how well it will work to help people with estrogen receptor positive (ER+), HER2 negative (HER2-) locally advanced or metastatic breast cancer previously treated with endocrine therapy. The main reason for you to take part in this study is not to treat you for your condition but to help in answering the following research question: How LY3484356 compares to investigator’s choice of either fulvestrant or exemestane for the treatment of ER+, HER2- breast cancer. Are you Eligible? (Inclusion Criteria) Must...
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and

Principal Investigator:

Ran Reshef, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03394365

Population:

Pediatrics/Adult

Phase:

III

Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono”. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (like people who have had a transplant and must be on medications that suppress their immune system), EBV can cause certain diseases where cells grow abnormally. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) is a condition that can occur after a solid organ transplant (SOT) where EBV infects immune cells in your blood, called B...
MIRASOL/ GOG-3045: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum Resistant Advanced High- Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High

Principal Investigator:

Jason D. Wright, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04209855

Population:

Adult

Phase:

III

The purposes of this study are: -To compare MIRV, an experimental drug made by ImmunoGen, Inc. (the Sponsor of this clinical research study) to standard chemotherapy. The term “experimental” means that the study drug has not been approved by any Health Authority that regulates new medicines. - To find out what effects, both good and/or bad, the study drug may have on you and your type of cancer. Are you Eligible? (Inclusion Criteria) fallopian tube cancers 2. platinum-resistant disease (defined as progression within 6 months from completion of a minimum of four cycles of platinum-...

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