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AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT), A Phase 2/3 Study, An Intergroup Study by Société Internationale d’Oncologie Pédiatrique (SIOPEL) in collaboration with COG and the Japanese

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03533582

Population:

Pediatrics/Adult

Phase:

II/III

s phase 2/3 study is examining the best treatments for pediatric liver tumors. It is looking to improve survival for patients with a poor prognosis while potentially reducing therapy and the risk for side effects in patients with good prognoses. Hepatoblastoma and hepatocellular carcinoma are the liver tumors being studied. Are you Eligible? (Inclusion Criteria) Patients must be 30 years of age or younger Patients must have not previously received treatment for either hepatoblastoma or hepatocellular carcinoma Patients must also meet all eligibility criteria as outlined in the study protocol...
An International, Seamless Phase II/III Responsive Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM (GBM AGILE)

Principal Investigator:

Andrew B. Lassman, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03970447

Population:

Adult

Phase:

II/III

The purpose of this study is to evaluate multiple investigational treatments for either newly diagnosed or recurrent brain tumors to determine if any of these study treatment(s) improve overall survival as compared to standard treatments. Investigational means that these are new treatments sometimes called “study drugs” and are not approved by the Food and Drug Administration (FDA) to be used for your type of cancer. The investigational treatments in this study have been previously tested in people. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you...
A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04396860

Population:

Adult

Phase:

II/III

This study is being done to answer the following question: Can we lengthen time without your brain tumor returning or growing and can we extend your life by replacing the usual chemotherapy with immune therapy? We are doing this study because we want to find out if this approach is better, the same, or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors. Are you Eligible? (Inclusion Criteria) Have you recently been diagnosed with glioblastoma? Are you 18 years of age or older? Are you willing to have radiation...
A Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04799275

Population:

Adult

Phase:

II/III

This study is being done to answer the following questions: Will patients that are 75 years of age or older who were recently diagnosed with Diffuse Large B Cell Lymphoma (DLBCL) be able to take the study drug CC-486 (oral azacitidine) plus the standard drug therapy that fights cancer cells for at least 4 cycles of therapy (a cycle = 21 days; 4 cycles is 12 weeks): • without significantly more side effects than patients taking the standard drug therapy alone? • have longer, shorter, or the same amount of time without the disease getting worse (progression) than patients taking the...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study toEvaluate AL102 in Patients with Progressing Desmoid Tumors

Principal Investigator:

Gary K Schwartz, MD

Contact Number:

212-342-5162

NCT Number:

NCT04871282

Population:

Adult

Phase:

II/III

You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the “study drug”), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study drug and how your body processes the drug . The study drug works by stopping a chemical pathway in the cells that allows desmoid tumors to grow. It is hoped that by stopping this pathway the study drug will stop desmoid tumor...
10005- A Phase 2 Study of Anti-PD-L1 Antibody MPDL3280A (Atezolizumab) in Alveolar Soft Part Sarcoma

Principal Investigator:

Gary K Schwartz, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03141684

Population:

Adult

Phase:

II
AALL1521 - A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02723994

Population:

Pediatrics

Phase:

II

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1. Are you Eligible? (Inclusion Criteria) Subjects must be at least 1 year and up to 21 years of age at the time of study entry. Patients must have been diagnosed with Ph-like B-ALL. Patients...
A single-arm, multi-center phase II trial of bendamustine/rituximab induction followed by venetoclax and rituximab consolidation for the frontline treatment of chronic lymphocytic leukemia

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03609593

Population:

Adult

Phase:

II

The purpose of this study is to determine the effectiveness of the study treatment- bendamustine and rituximab (BR) followed by venetoclax for 12 months. The combination of the drugs bendamustine and rituximab is a commonly used treatment for your disease. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. With this combination we hope to increase response to therapy and reduce the risk of tumor lysis syndrome. In addition, we hope to reduce the total time on therapy by limiting treatment with venetoclax to 12 months in duration. Are you Eligible? (...
A PHASE 2, MULTI-COHORT, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF bb2121 IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA AND IN SUBJECTS WITH CLINICAL HIGH-RISK MULTIPLE MYELOMA (KarMMa-2)

Principal Investigator:

Ran Reshef, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03601078

Population:

Adult

Phase:

II

The purpose of this study is to determine if the investigational therapy called bb2121 is effective in treating multiple myeloma. bb2121 is a type of therapy known as chimeric antigen receptor (CAR) T cell therapy. T cells are a kind of white blood cell which form part of your body’s immune system. Your T cells will be separated from the rest of the immune cells and then modified to make the bb2121 T cells. The bb2121 T cells manufactured for you will be shipped to the study site when you are ready for the treatment and infused back into your blood. Are you Eligible? (Inclusion Criteria...

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