December 2014

Hematologic Malignancies Clinical Trials

Hematologic Malignancies And Stem Cell Transplant Newsletter

Dear Colleague,

In this issue of our clinical trials newsletter we highlight, studies that expand our therapeutic options for hematologic malignancies, with and without stem cell transplantation.

Donor availability used to be the major limitation to offering allogeneic hematopoietic stem cell transplantation to patients in need of this form of treatment. Over the past decade, however, large steps have been accomplished toward overcoming the ‘HLA barrier,’ and today we are able to find donors for most of our patients.

We are now confronted with a different set of questions. Should a patient be offered a cord blood or a haploidentical transplant? What about an unrelated donor transplant? In parallel with new approaches to performing cord blood or haploidentical transplants, donor registries have also increased, and our knowledge of potentially permissible donor-recipient HLA mismatches is entering the clinical arena.

We therefore aim at having Donors for Everybody, expanding the access to stem cell transplant. Additionally, our treatment strategies in transplant are also looking for ways to make this procedure less toxic while at the same time Preventing Relapse After Stem Cell Transplant.

Expanding access to transplant also implies exploring new curative approaches to nonmalignant diseases in the adult.

Allogeneic Transplant for Sickle Cell Anemia is a new study that aims at providing selected patients with this condition the possibility of receiving an allogeneic transplant.

Outside the transplantation arena, two new trials are aimed at investigating Novel Therapies for Early Stage Indolent Lymphoid Malignancies.

Feel free to contact us if you have any questions.

Marcos de Lima, MD
Paolo F. Caimi, MD

Donors For Everybody

MESO 1Z12: MSC Expanded Umbilical Cord Blood Transplant

Umbilical cord blood expansion through co-culture with mesenchymal stem cells (MSC) to increase the cell dose has the potential to shorten engraftment times and decrease the risk of infections and other complications after transplant. This randomized study is comparing double UCB transplant in which one unit is ex vivo expanded versus ‘standard’ double, unmanipulated double cord blood transplant. Eligible patients include those with acute myeloid or lymphoblastic leukemia, Hodgkin and non Hodgkin lymphoma.

For more information contact:
Marcos de Lima, MD, at
Marcos.deLima@UHhospitals.org

CTN 1101: Umbilical Cord Blood vs. Haploidentical Transplants

Patients without a matched related or unrelated donor are eligible. The study compares umbilical cord blood versus a related mismatched donor (haploidentical). This important cooperative group trial is comparing double UCB transplant with haploidentical transplant for patients with acute leukemia or lymphoma.

BELL 1Z12: Haploidentical SCT with Genetically Modified T Cells to Stop GVHD

This novel trial is exploring the use of T cell depleted haploidentical transplant co-infused with genetically modified T cells carrying a suicide gene that allows for pharmacologically switching off T cell response in case of GVHD. This study represents the next generation of cell therapies and will allow for better tolerated and more effective alternative donor transplants.

For more information contact:
Hillard M. Lazarus, MD at
Hillard.Lazarus2@UHhospitals.org

Preventing Relapse After Transplant

UNMC 1413: Lenalidomide Maintenance After Autologous SCT

Many patients with non-Hodgkin lymphoma continue to have a high risk of relapse after autologous stem cell transplant. This study is investigating the use of lenalidomide maintenance after autologous transplant in high-risk lymphoma patients. Eligible are patients with early relapse or refractory disease after first line, PET positive disease at time of transplant or those with high-risk lymphomas such as transformed lymphoma, Mantle Cell Lymphoma, PTCL, Alk Negative ALCL.

For more information contact:
Basem W. William, MD at
Basem.William@UHhospitals.org

CASE 9Z13: Targeted Marrow Irradiation in Reduced Intensity Stem Cell Transplant

Reduced intensity conditioning regimens are better tolerated, but are frequently associated with a higher relapse risk. This Phase I trial is investigating the addition of targeted marrow irradiation to reduce intensity conditioning in order to decrease the risk of relapse. Eligible patients include patients with hematologic malignancies that require an allogeneic transplant.

For more information contact:
Paolo F. Caimi, MD and David Mansur, MD, at
Paolo.Caimi@UHhospitals.org and David.Mansur@UHhospitals.org

Allogeneic Transplant For Sickle Cell Anemia

CCASE 12Z13: Allogeneic Transplant for Patients with Sickle Cell Anemia

Patients will high-risk sickle cell anemia experience significant complications and are at high risk for death from their disease. An allogeneic transplant has the potential for establishing normal hemoglobin synthesis and curing their disease. This trial is testing the use of a reduced intensity conditioning regimen with additional immunomodulation for transplant of sickle cell anemia patients to decrease risk of toxicity of transplant and improve the engraftment of donor cells. Use alternative grafts (umbilical cord blood, haploidentical donors) will be included.

For more information contact:
Jane Little, MD at
Jane.Little@UHhospitals.org

Novel Therapies For Early Stage Indolent Lymphoid Malignancies

CASE 5913: Curcumin and Vitamin D for Patients with Early-Stage CLL Or SLL

There is no current standard therapy for patients with early-stage CLL. Cytotoxic agents have not demonstrated a survival benefit, and have a risk of toxicity. Curcumin and Vitamin D are two low-risk agents that could potentially delay CLL progression. This study is exploring the use of curcumin combined with Vitamin D for the treatment of CLL patients that would otherwise undergo observation only.

PRE 1413: Rituximab vs. Obinotuzumab for Patients with Low-Burden, Advanced-Stage Follicular Lymphoma

Patients with advanced-stage, low-burden follicular lymphoma are usually observed. Treatment with cytotoxic agents has not been shown to improve survival. Rituximab treatment followed by maintenance improves progression-free survival, but does not affect overall survival. This trial is comparing rituximab with the next generation – anti-CD20 therapy obinotuzumab. Eligible patients are those with advanced-stage, low-burden follicular lymphoma who do not require treatment and would otherwise continue on watchful waiting.

For more information contact:
Basem William, MD at
Basem.William@UHhospitals.org

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Stanton Gerson

Stan Gerson, MD
Director, University Hospitals Seidman Cancer Center Director, Case Comprehensive Cancer Center Director, National Center for Regenerative Medicine

Neal Meropol

Neal Meropol, MD
Chief, Division of Hematology and Oncology Associate Director for Clinical Programs University Hospitals Seidman Cancer Center at UH Cleveland Medical Center Associate Director for Clinical Research Case Comprehensive Cancer Center

New Mobile App for Clinical Trials

UH Seidman Cancer Center has launched a clinical trials search website and mobile-device app developed especially for cancer patients. These new tools provide intuitive interfaces with easy-to-understand language for browsing more than 150 available cancer clinical trials offered in collaboration with the Case Comprehensive Cancer Center. To date, hundreds of patients have taken advantage of these new search capabilities, directing them to clinical trials where appropriate, or to a nurse who answers their questions.