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AAML18P1: Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03817398

Population:

Pediatrics/Adult

Phase:

II

This is a pilot study in pediatric and young adult patients with chronic phase CML (CML-CP) who are currently being treated with a tyrosine kinase inhibitor (TKI). Treatment with a TKI is currently life long. Pediatric patients with CML have long life spans, therefore they will be taking a TKI for a long time, especially during periods of growth and development, and therefore are believed to be at a significantly increased risk for side effects. Patients in this study will stop taking TKI medication and be closely monitored for 3 years to see if they remain cancer free. If their CML returns,...
AALL1721: A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03876769

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out if the study drug, tisagenlecleucel, is safe and has benefits for people who have high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) and have a tiny number of leukemia cells still present in their bone marrow (MRD positive) at the end of consolidation (EOC) therapy. Tisagenlecleucel is a product made up of the patient's own T cells that have been changed to be able to identify and kill leukemia cells. Patients will receive chemotherapy followed by tisagenlecleucel and then be monitored to see how well the treatment worked. Are you Eligible? (...
AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04322318

Population:

Pediatrics/Adult

Phase:

II

This is a Phase 2 study of patients for the treatment of patients with high risk Wilms tumors (including those with diffuse anaplastic Wilms tumor- DAWT) and those who have relapsed favorable histology Wilms tumor (FHWT). The main goal of the study is to find out whether treatment with chemotherapy consisting of vincristine/irinotecan; cyclophosphamide/carboplatin/etoposide; and vincristine/doxorubicin/cyclophosphamide) improves the survival of patients with newly diagnosed Stage 4 diffuse anaplastic Wilms tumor (DAWT) or Standard-Risk relapsed favorable histology Wilms tumor (SRrFHWT) as...
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With

Principal Investigator:

Brian John Andrew Gill, MD

Contact Number:

212-342-5162

NCT Number:

NCT04485949

Population:

Adult

Phase:

II

The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placeboto see if it works in slowing glioblastoma multiforme (GBM) tumor regrowth. SOC refers to the usual medicine(s) or procedures used to treat your cancer. A placebo looks like the study medicine but does not contain any medication (active ingredient). Researchers use a placebo to see if a study medicine works better or is safer than not taking anything at all. Are you Eligible? (Inclusion Criteria) you are between the ages of 18 and 70 years you have a...
AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04546399

Population:

Pediatrics/Adult

Phase:

II

This is a study looking at how well the combination treatment of Blinatumomab and Nivolumab works in patients with first relapse of B-cell Acute Lymphoblastic Leukemia (B-ALL) as compared to treatment with only Blinatumomab. In addition, it is looking at what effects, good and/or bad the treatment has. First relapse means that B-ALL has come back after the initial treatment a patient received for B-ALL. All patients will receive treatment with Blinatumomab, an antibody (protein) that targets a marker on B-ALL cells and then uses your immune system to kill the B-ALL cell. Some patients will...
A Phase 2 Multiple Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination with Chemotherapy or Targeted Therapies in Selected Subjects with Metastatic

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05005728

Population:

Adult

Phase:

II

the purpose of this research study is to determine the safety and tolerability of XmAb20717 by itself and in combination with other anticancer therapies (Olaparib, Cabazitaxel, Docetaxel and Carboplatin). XmAb20717 has not been studied in a significant number of humans, therefore, some of its effects are unknown. XmAb20717 is an investigational antibody drug. An antibody is a kind of protein that your body makes to help fight infections. AmAb20717 is an investigational drug in this study because it has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that...
Audiovisual Didactic Experience for Latino patient treatment Adherence and Non-English speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology

Principal Investigator:

Lisa Ann Kachnic, MD, FASTRO

Contact Number:

212-342-5162

NCT Number:

NCT05351424

Population:

Adult

Phase:

II

In this study, you will be randomized to receive either a brochure or watch a video that discusses radiation and cancer clinical trials. In addition, you will complete questionnaires at seven time points: 1 questionnaire before radiotherapy, 4 questionnaires during the course of radiotherapy and 2 questionnaires at follow-up visits. The questionnaires and brochure or video administration will take place during your standard of care visits. Are you Eligible? (Inclusion Criteria) To be included in the main study, you must: 1. be age 18 years or older 2. be Spanish speaker of Latino Background...
ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT04904588

Population:

Adult

Phase:

II

with a MMUD using stem cells from a donor’s blood [instead of using the donor’s bone marrow]. An allogeneic stem cell transplant is a standard treatment for blood cancers. An allogeneic transplant replaces your abnormal (or diseased) blood cells with healthy blood-making cells from a donor. We’re doing this study to see how well transplant works in adults with a MMUD using stem cells from a donor’s blood. This study treatment does not include any investigational drugs. Are you Eligible? (Inclusion Criteria) Donor: 1. Are you 18 year of age or older and younger then 36...
A Safety Run-In and Phase II Study Evaluating the Efficacy, Safety, and Impact on the Tumor Microenvironment of the Combination of Tocilizumab, Atezolizumab, and Fractionated Stereotactic Radiotherapy in Recurrent Glioblastoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT04729959

Population:

Adult

Phase:

II

This study is being done to answer the following question: Can we shrink or stabilize your brain cancer by adding immune therapy drugs to the usual radiation therapy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your recurrent glioblastoma. The usual approach is defined as care most people get for recurrent glioblastoma. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Have you been diagnosed with glioblastoma that has come back after previous radiation therapy? Are you able to make regularly...
A randomized phase II study of CHO(E)P vs CC-486-CHO(E)P vs duvelisib-CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04803201

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to compare the usual treatment alone to using duvelisib or CC-486 plus the usual treatment for patients with peripheral T-cell lymphoma. The usual approach for patients who are not in a study is treatment with the FDA approved chemotherapy regimens used in this trial (CHOP or CHOEP) without the addition of the study drugs duvelisib or CC-486 (azacitidine). The addition of duvelisib or CC-486 (azacitidine) to the usual treatment may or may not increase the chance of cancer going into remission. But, it could also cause side effects, which the study doctors want to...

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