Clinical Trials

Sheba Medical Center is at the forefront of medical research, exploring new treatments and technologies for a wide range of diseases and conditions. Our world-class physicians collaborate with leading hospitals, laboratories, biotech and pharmaceutical companies to constantly improve medical care. Sheba is engaged in the latest clinical research and studies, striving to push the boundaries of global health care.

What is a clinical trial?

A clinical trial is the study of a new treatment, technology, and diagnostic approach in patient care. In general, a clinical trial aims to answer a specific question about the efficacy or safety of a drug, device, or other medical treatment. To investigate the benefits and risks of new, cutting-edge therapies, doctors need volunteer patients to participate in clinical trials.

What are the phases of a clinical trial?

Clinical trials consist of five phases:

Phase 0: These are the first clinical trials conducted among people. Generally, a very small dose of a drug is given to a very small group of people, less than 15.

Phase I: The primary goal of phase I trials is to test a drug’s safety. These trials aim to determine the best dose of a new drug, with the fewest side effects. Testing is typically done in a small group of 15 to 30 patients. If the drug is found to be safe enough, it can be assessed in a phase II clinical trial.

Phase II: In this phase, the trial further evaluates the safety and efficacy of a drug. Frequently, the drug is tested among patients with a specific type of cancer and the group of subjects is generally larger. If the drug works, it can be tested in a phase III clinical trial.

Phase III: In phase III trials, a new drug is compared to the conventional drug in use. The side effects of each drug and which one works better is evaluated. Phase III trials are typically conducted with 100 or more patients, and the trials are often randomized, with a control group and a group receiving the new treatment. The study will be terminated early if the side effects of the new treatment are too severe or if one group has significantly better results. Phase III trials are required in order to obtain FDA approval.

Phase IV: These trials test new drugs that have been approved by the FDA, and testing is usually done in very large groups of hundreds or thousands of patients. Phase IV trials enable doctors to learn more about how the drug works and if the effects are improved when it is combined with other treatments.

Why participate in a clinical trial?

  • A successful clinical trial may improve your quality of life and life expectancy
  • To enhance the treatment that you are already receiving
  • Other therapies to treat your condition have not been successful
  • Participants in clinical trials are the first to benefit from advanced therapies
  • Many treatment drugs and test procedures that are given in a clinical trial are free to the participants
  • A clinical trial gives you the chance to contribute to the medical understanding of a disease or condition, as well as to help advance treatment options for all patients

Clinical trials are necessary for advancing medicine and improving the lives of patients everywhere. If you are interested in participating in a clinical trial, Sheba is actively conducting studies on a wide range of diseases.


Clinical Trials

Sheba Medical Center is at the forefront of medical research, exploring new treatments and technologies for a wide range of diseases and conditions. Our world-class physicians collaborate with leading hospitals, laboratories, biotech and pharmaceutical companies to constantly improve medical care. Sheba is engaged in the latest clinical research and studies, striving to push the boundaries of global health care.

What is a clinical trial?

A clinical trial is the study of a new treatment, technology, and diagnostic approach in patient care. In general, a clinical trial aims to answer a specific question about the efficacy or safety of a drug, device, or other medical treatment. To investigate the benefits and risks of new, cutting-edge therapies, doctors need volunteer patients to participate in clinical trials.

What are the phases of a clinical trial?

Clinical trials consist of five phases:

Phase 0: These are the first clinical trials conducted among people. Generally, a very small dose of a drug is given to a very small group of people, less than 15.

Phase I: The primary goal of phase I trials is to test a drug’s safety. These trials aim to determine the best dose of a new drug, with the fewest side effects. Testing is typically done in a small group of 15 to 30 patients. If the drug is found to be safe enough, it can be assessed in a phase II clinical trial.

Phase II: In this phase, the trial further evaluates the safety and efficacy of a drug. Frequently, the drug is tested among patients with a specific type of cancer and the group of subjects is generally larger. If the drug works, it can be tested in a phase III clinical trial.

Phase III: In phase III trials, a new drug is compared to the conventional drug in use. The side effects of each drug and which one works better is evaluated. Phase III trials are typically conducted with 100 or more patients, and the trials are often randomized, with a control group and a group receiving the new treatment. The study will be terminated early if the side effects of the new treatment are too severe or if one group has significantly better results. Phase III trials are required in order to obtain FDA approval.

Phase IV: These trials test new drugs that have been approved by the FDA, and testing is usually done in very large groups of hundreds or thousands of patients. Phase IV trials enable doctors to learn more about how the drug works and if the effects are improved when it is combined with other treatments.

Why participate in a clinical trial?

  • A successful clinical trial may improve your quality of life and life expectancy
  • To enhance the treatment that you are already receiving
  • Other therapies to treat your condition have not been successful
  • Participants in clinical trials are the first to benefit from advanced therapies
  • Many treatment drugs and test procedures that are given in a clinical trial are free to the participants
  • A clinical trial gives you the chance to contribute to the medical understanding of a disease or condition, as well as to help advance treatment options for all patients

Clinical trials are necessary for advancing medicine and improving the lives of patients everywhere. If you are interested in participating in a clinical trial, Sheba is actively conducting studies on a wide range of diseases.


Multiple clinical trials worldwide have used autologous T-cells transduced with chimeric antigen receptors (CAR) that recognize the CD19 antigen. At Sheba, we established an in-house manufacturing process for CD19-CAR T-cells with a CD28 (cluster of differentiation 28) costimulatory domain.

This phase I and II interventional study aims to evaluate the response of B-cell malignancies expressing CD19 to autologous T cells transduced with a second generation anti-CD19 chimeric antigen receptor in children and young adults. The primary objective of this study is to investigate the safety of administration of CAR T-cell therapy, and to determine the efficacy and feasibility of administering anti-CD19-CAR T-cells in children and young adults with B cell malignancies. The secondary objective is to study the in vivo behavior of CAR T-cells in patients, including expansion, persistence, cytotoxic potential, and exhaustion, in addition to considering the cytokine milieu in patients who have been treated with CAR T-cell therapy.

In this clinical study, leukapheresis will be used to obtain peripheral blood mononuclear cells (PBMCs). Anti-CD19 CAR T-cells will then be manufactured from fresh autologous PBMCs. To do this, PBMCs will be cultured in the presence of anti-CD3 (cluster of differentiation 3) antibody and interleukin-2, followed by retroviral vector supernatant with the anti-CD19 CAR. The total culture time takes between 7-10 days. Before cell infusion, study participants will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine). On day 0, they will receive one million CAR T-cells per kilogram of body weight. Patients will then be monitored for toxicity, response of their underlying malignancy, and the presence of CAR T-cell persistence in the blood, marrow, and cerebral spinal fluid (CSF).

Condition or disease:
#Acute Lymphoblastic Leukemia,
#B-precursor;
#Non-Hodgkin Lymphoma,
#B-cell

Eligibility: Patients 1-50 years of age, male and female, with a CD19-expressing B-cell malignancy that has recurred after, or failed to respond to, one or more standard chemotherapy-containing regimens

Contact:
Amos Toren, MD, PhD
Elad Jacoby, MD

Read more >>

Clinical trials are necessary for advancing medicine and improving the lives of patieThe hypotheses of this phase II study are that the introduction of dose escalated thiotepa, instead of the drugs busulfan or melphalan, will reduce toxicity after allogeneic transplantation – while at the same time improving the eradication of disease in patients with lymphoid malignancies who are not eligible for standard transplantation. The primary objective of this interventional study is to investigate the effects of the drug treatment.ts everywhere. If you are interested in participating in a clinical trial, Sheba is actively conducting studies on a wide range of diseases.

Condition or disease: Non-Hodgkin Lymphoma; Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma

Eligibility: Patients 18-68 years of age, male and female

Contact: Avichai Shimoni, MD

Principal Investigator: Arnon Nagler, MD

Read more >>

This phase I and II study aims to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in improving the response to Imatinib in patients with chronic myelogenous leukemia (CML) not achieving an optimal response with imatinib alone.

Imatinib is a standard treatment for CML. However, not all patients achieve an optimal response to imatinib, according to the definitions of the European LeukemiaNet (ELM) or of the MR4 after receiving imatinib for 24 months. In this interventional study, the CXCR4 antagonist BL-8040 will be added to mobilizing CML leukemia stem cells from their protective bone marrow niche and expose them to imatinib and BL-8040 mediated apoptosis. The primary goal of this clinical trial is to assess the effects of the drug treatment.

Condition or disease: Chronic Myeloid Leukemia

Eligibility: Patients 18-70 years of age, male and female

Principal Investigator: Arnon Nagler, MD

Read more >>

Currently, therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL) are disappointing. Eventually, most of these patients will undergo allogeneic stem cell transplantation.

This phase II interventional study investigates the use of Nilotinib, a novel TKI tyrosine kinase inhibitor that is 30x more potent than Imatinib. Based on previous preliminary studies, the author proposes that using Nilotinib therapy prior to allogeneic transplantation for patients with advanced CML and Ph+ ALL will reduce tumor mass pre-transplant. These effects achieve a state of minimal residual disease (MRD) and may therefore improve the outcome of transplantation without increasing the level of toxicity. In addition, the use of Nilotinib will provide time for improving the patient’s medical condition and locating a suitable unrelated donor for allogeneic transplantation. It will also allow time to induce anti-tumor effect post PBSC without DLI (donor lymphocyte infusion).

Condition or disease:

# Chronic Myeloid Leukemia;

# Acute Lymphoblastic Leukemia;

# Stem Cell Transplantation

Eligibility: Patients 18-65 years of age, male and female

Contact: Arnon Nagler, MD

Read more >>

This is a phase III study, controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response following more than one year of imatinib therapy. The objective of this clinical trial is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib. In particular, the rate of achievement, molecular remission, and response duration are being evaluated.

Condition or disease: Leukemia, Myeloid, Philadelphia-Positive

Eligibility: Patients 18-70 years of age, male and female

Principal Investigator: Izhar Hardan, MD

Read more >>

The goal of this phase II study is to assess the efficacy of TevaGrastim in mobilizing a sufficient quantity of stem cells from normal sibling donors for allogeneic stem cell transplantation. TevaGrastim is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF).

Condition or disease: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Eligibility: Patients 18-70 years of age, male and female

Principal Investigator: Arnon Nagler, MD

Read more >>

The hypotheses of this phase II study is that the introduction of dose-escalated treosulfan (as a substitute for busulfan), will reduce toxicity after allogeneic transplantation in patients with AML and MDS who are not eligible for standard transplantation. At the same time, this clinical trial will evaluate the effects of treosulfan on improving myeloablation and disease control in these patients.

Condition or disease:

#Acute Myeloid Leukemia;

#Myelodysplastic Syndrome.

Eligibility: Patients 18-68 years of age, male and female

Principal Investigator: Arnon Nagler, MD

Read more >>

The objective of this observational study was to investigate the occurrences of risk factors for respiratory symptoms and abnormalities in lung function in young children with hemato-oncologic diseases at presentation. The study assessed the patients before treatment and during follow-up, up to 3 years later.

Pulmonary function tests (PFTs) are a part of the routine follow-up care for patients receiving anti-cancer treatment. Frequently, the anti-cancer treatment is associated with diverse pulmonary damage, which may only become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs. By helping to evaluate the point at which lung function deviates from normal, PFTs may enable early intervention before irreversible lung damage occurs. Morbidity and mortality may thereby be reduced.

When treating preschool age children, reliable PFTs have traditionally been difficult to perform. However, recent publications have demonstrated that proper coaching techniques can teach the majority of preschool children how to produce reproducible forced expiratory flow volume (FEVC) curves. This recent development may facilitate investigating the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

Condition or disease:
#Acute Lymphoblastic Leukemia;
#Acute Myeloblastic Leukemia;
#Solid Tumors;
#Hodgkin’s Disease; Non-Malignant
Eligibility: Patients 3-7 years old, male and female
Principal Investigator: Ori Efrati, MD
Read more >>

The purpose of this interventional clinical trial is to determine whether the addition of AS101 to the standard chemotherapy regimen is effective in the treatment of newly diagnosed elderly patients with AML and AML transformed myelodysplastic syndrome (MDS).

AML patients often develop cytopenia, which can lead to life-threatening bleeding and infections. Despite the administration of prophylactic platelet transfusions, these patients are still at risk for clinically significant hemorrhage.

In the last three decades, the outcome for AML patients (specifically the older ones) has not changed substantially. Therefore, there is an immense need for novel, innovative treatment strategies. In order to improve the prognosis for AML patients, it is imperative to develop new compounds to target the tumor cells’ resistance to chemotherapeutic agents. AS101 is a non-toxic, organic, tellurium-based small compound with immunomodulating properties, which has shown a bone marrow sparing effect in the past. Additionally, preclinical studies have demonstrated the synergistic effect of AS101 with several cytotoxic drugs.

This phase II study will investigate the safety and efficacy of AS101 formulation, combined with the standard therapy currently in use for elderly patients newly diagnosed with AML and AML transformed MDS patients.

Condition or disease:
#Acute Myeloid Leukemia;
#Myelodysplastic Syndrome

Eligibility: Patients 60-85 years of age, male and female
Sponsor: BioMAS Ltd
Read more >>

This is a phase II study of the Bruton’s Tyrosine Kinase Inhibitor, PCI-32765 (ibrutinib), used in combination with bendamustine and rituximab (BR) to treat subjects with previously treated aggressive B cell non Hodgkin lymphoma (aB-NHL). Eligible subjects include patients with any subtype of diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), double- and triple-hit DLBCL, transformed indolent lymphoma, and unclassifiable aggressive B cell lymphoma between DLBCL and Burkitt lymphoma. (Patients with CNS involvement (primary or secondary) will be excluded).

Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent, and covalently-binding small molecule inhibitor of Bruton’s tyrosine kinase. Orally-administered, at present it is FDA-approved for the treatment of relapsed mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and Waldenstrom macroglobulinemia (WM).

Ibrutinib is being studied constantly as a treatment for other B-cell malignancies. On November 13, 2013, the FDA gave initial approval of ibrutinib for the treatment of adult patients with MCL who have received at least one prior therapy. Although the phase I trial in this setting has already been published, ibrutinib has not been approved by the FDA for marketing for the treatment of aggressive B cell lymphoma.

In Israel, ibrutinib is registered for the treatment of MCL and CLL. This study is a phase II single arm clinical trial that is designed to test the efficacy of ibrutinib in combination with BR in relapsed aB-NHL, either as third line post ASCT or as second or third line in non-transplant eligible patients. Through the Israeli Lymphoma Working Group, patients will be referred for this study from medical centers all over Israel, yet treatment will only be given at Sheba Medical Center.

The interventional study will include a Screening Phase, Treatment Phase, and Post-treatment Follow-up Phase. Subject eligibility will be determined up to 30 days prior to beginning the therapy, and the treatment phase will extend from cycle 1, day 1, until discontinuation of the study drug, either due to progression, toxicity, or referral to allo-stem cell transplantation.

Throughout the study, ibrutinib will be administered orally once a day on cycle 1, day 1. This program will continue on a constant schedule until disease progression, referral for allo-SCT, or unacceptable toxicity – whichever comes first. At the end of 6 cycles of BR, the post-treatment Follow-up Phase will begin. Subjects who discontinue treatment for reasons other than disease progression must continue disease evaluations.

At each site visit, subjects will be examined for toxicity. Safety evaluations will include adverse event monitoring, physical examinations, concomitant medication usage, and clinical laboratory parameters. The Post-treatment Follow-up Phase will continue until death, loss to follow-up, consent withdrawal, or end of study – whichever occurs first.

Assessment of tumor response and progression will be conducted according to the Lugano criteria for malignant lymphoma. The investigator will use radiological imaging, physical examination, or other necessary procedures to evaluate sites of disease. The primary efficacy analysis of ORR will be based on investigator assessment.

Condition or disease:
#Diffuse Large B Cell Lymphoma;
#Primary Mediastinal (Thymic) Large B-cell Lymphoma;
#Transformed Indolent Lymphoma;
#Recurrent Disease;
#Refractory Cancer
Eligibility: Patients 18 years of age and older, male and female
Principal Investigator: Meirav Kedmi, MD
Read more >>

top 10 banner 1

Get Consultation Now

Get Consultation Now

By submitting this form you agree to have your information used for consultation purposes only in accordance with our Privacy Policy.

Get Consultation

Request a consultation