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A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic

Principal Investigator:

Ran Reshef, MD

Contact Number:

212-342-5162

NCT Number:

NCT03666000

Population:

Adult

Phase:

I/II

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers. PBCAR0191 is a new investigational treatment for certain types of cancer of the blood, such as leukemia and lymphoma. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill some types of cancer cells. Are you Eligible? (Inclusion Criteria) Must be 18 years of age or older Must have received at least 2...
AAML1531: Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02521493

Population:

Pediatrics

Phase:

III

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid...
Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03258931

Population:

Adult

Phase:

III

The purpose of this study is to compare the efficacy of crenolanib versus midostaurin (RYDAPT®) in newly diagnosed acute myeloid leukemia patients with FLT3 mutations. Crenolanib is an investigational product, which means that it has not yet been approved for sale in the United States by the Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Are you between the age ≥ 18 years and ≤ 60 years? (2) Do you have Diagnosis of AML? (3) Do you agree to not participate in another study while on treatment for this study?
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

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 randomized, double-blind trial to evaluate the safety and efficacy of apraglutide in subjects with Grade II to IV (MAGIC) steroid refractory gastrointestinal (GI) acute graft versus host disease on best available therapy

Principal Investigator:

Ran Reshef, MD

Contact Number:

212-342-5162

NCT Number:

NCT05415410

Population:

Adult

Phase:

II

The purpose of this trial is to investigate if the study drug apraglutide is safe and helpful when given with the drug ruxolitinib in subjects with acute graft versus host disease for whom steroid treatments alone have been unsuccessful. Ruxolitinib has been approved by the United States Food and Drug Administration (US FDA), for use as the second line of treatment for acute graft versus host disease, but sometimes the graft versus host disease does not respond completely to ruxolitinib. This study is also being done to see whether apraglutide can reduce the damage to the intestines caused by...
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Patients Undergoing Haploidentical Allogeneic Peripheral

Principal Investigator:

Ran Reshef, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

I

The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100 and TSC-101 are experimental new study drugs that have not yet been approved by the US Food and Drug Administration (FDA) or regulatory authorities in any other countries. This is a first-in-human study, which means that these study drugs...
ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03834961

Population:

Pediatrics

Phase:

II

The purpose of this study is to determine how well Larotrectinib works in treating patients with newly diagnosed TRK fusion solid tumors or relapsed or refractory TRK fusion acute leukemias. TRK fusion means that you have a change in the TRK gene in your tumor. Larotrectinib is a highly selective oral small molecule inhibitor of the TRK family of tyrosine kinases, which are encoded by the NTRK genes. Are you Eligible? (Inclusion Criteria) Patient must be 30 years of age or younger at time of study entry Patient must have: Cohorts A & B: newly diagnosed infantile fibrosarcoma or any solid...
Phase 1/2 Study of PO Ixazomib in Combination with Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03817320

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the best dose of Ixazomib that can be given safely with chemotherapy in children with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) which has come back or has not responded to standard therapy. Ixazomib works by preventing breakdown of proteins in cells, causing the cells to die. Ixazomib will be given by mouth on days 1, 4, 8 and 11 of the 35-day cycle. It will be given in combination with standard chemotherapy. Are you Eligible? (Inclusion Criteria) Patients must have relapsed or refractory ALL or relapsed or refractory LL Patients...
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...
Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia

Principal Investigator:

Elena J. Ladas, PhD, RD

Contact Number:

(212) 342-5162

NCT Number:

NCT03157323

Population:

Pediatrics/Adult

Phase:

NA

The purpose of this study is to determine the feasibility, measured by compliance to a low-GI diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. Are you Eligible? (Inclusion Criteria) (1) Children and adolescents diagnosed with ALL between the age of 5-21 years of age, (2) Within three days of starting the induction phase of therapy for ALL (B- Cell, T-Cell, or Mixed Phenotype), and (3) Proficient in English or Spanish.

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