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A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06022939

Population:

Adult

Phase:

III

This study is being done to answer the following questions: • Do people with amyloid light chain (AL) amyloidosis respond better to a consolidation treatment that uses either one high dose of the drug melphalan plus stem cell transplant or more chemotherapy alone? • Which treatment plan gives patients a better quality of life? To determine which treatment plan works better against AL amyloidosis, the study is set up to find out how good the treatments are at lowering the chance of AL amyloidosis causing problems in major organs of the body. The researchers will compare the results...
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05827016

Population:

Adult

Phase:

III

The purpose of the study is to test the safety and efficacy of iberdomide in a larger number of patients. Iberdomide is not FDA approved for the treatment of any disease. This study will also assess how patients feel about the multiple myeloma treatment received in this study, and their quality of life as it relates to their health. Iberdomide is a medication taken by mouth that binds to a protein known as cereblon, which may result in the destruction of specific proteins by the body. This study drug may modify or regulate the functioning of the immune system and may induce the destruction of...
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCoud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

Principal Investigator:

Brian John Andrew Gill, MD

Contact Number:

212-342-5162

NCT Number:

NCT05902169

Population:

Adult

Phase:

III

The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard of care chemotherapy [Temozolomide and Lomustine] and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable(allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to...
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06016738

Population:

Adult

Phase:

III

The purpose of this study is to learn more about the investigational study drug called OP- 1250 (palazestrant) on participants with ER+, HER2- advanced or metastatic breast cancer. OP-1250 is considered endocrine therapy (treatment that adds, blocks, or removes hormones). Estrogen is a type of hormone naturally produced by the body that helps develop and maintain female sex characteristics and the growth of bones. Estrogen can also cause certain types of breast cancer to multiply, grow, and move to different parts of the body. Estrogen works in the body by binding to proteins called estrogen...
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06435429

Population:

Adult

Phase:

III

The purpose of this study is to find out whether zanidatamab combined with physician’s choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) is safe and improves on the clinical benefit when compared to trastuzumab in combination with physician’s choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) in treating the type of breast cancer you have, HER2-positive, metastatic (spread of cancer from the place where it started to other places in the body) breast cancer that is intolerant (drug is causing excessive side effects...
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib +Fulvestrant as Treatment for PIK3CA-mutant Hormone ReceptorPositive, Human Epidermal Growth Factor Receptor 2 Negative(HR+/HER2-)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06982521

Population:

Adult

Phase:

III

This study is being done to see how well a new, experimental drug called RLY-2608, when used together with another drug called fulvestrant, works compared to a currently approved treatment (capivasertib + fulvestrant) for a specific type of breast cancer. It’s for people who have hormone receptor-positive, HER2-negative breast cancer that has either spread in the body (metastatic) or grown into nearby tissues (locally advanced), and who also have a change (mutation) in a gene called PIK3CA. Are you Eligible? (Inclusion Criteria) ≥18 years of age. 2.Women in the study can be...
AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03067181

Population:

Pediatrics/Adult

Phase:

III

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Are you Eligible? (Inclusion Criteria)...
ANBL1531, A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or AlK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03126916

Population:

Pediatrics/Adult

Phase:

III

This randomized clinical trial is examining whether the addition of radio- labelled MIBG or Crizotinib will improve the survival of high risk Neuroblastoma patients, as compared to standard treatment. Patients will be non-randomly assigned to Crizotinib based on tumor testing. All other patients will be randomized to receive standard therapy or standard therapy + MIBG. Are you Eligible? (Inclusion Criteria) Between 1 and 30 years of age Have a diagnosis of High Risk Neuroblastoma Enrolled on ANBL00B1 Patients must also meet all other eligibility criteria as outlined in the study
AAML1831: A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04293562

Population:

Pediatrics

Phase:

III

This is a Phase 3 trial that will compare the efficacy of CPX-351 (a combination of 2 standard chemotherapy medicines - Daunorubicin and Cytarabine) compared to standard chemotherapy in the treatment of Acute Myelogenous Leukemia (AML). Patients will be randomly assigned by a computer to receive treatment with either CPX-351 treatment regimen or the standard chemotherapy regimen. In addition, if testing shows that a patient's AML has a specific gene change (FLT3), then those patients will be offered treatment with a new medicine (Gilteritinib) that targets the FLT3 gene change. For all...
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...

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