Clinical Trials

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 Transplant Trials
TITLE CTN 0303: A Single Arm, Multicenter Phase II Trial of Transplants of HLA-Matched, CD34+ Enriched, T cell Depleted Peripheral Blood Stem Cells (PBSC) Isolated by the CliniMACS System in the Treatment of Patients with AML in First or Second Morphologic Complete Remission 
DESCRIPTION This study will assess disease-free survival (DFS) at 6 months post-transplant. The trial is designed to assess the efficacy of HLA-identical sibling transplantation using PBSC grafts processed by the CliniMACS system and employing an intensive pre-transplant cytoreductive regimen. 
ELIGIBILITY
  1. Age 18 to 60 years
  2. Acute myeloid leukemia (AML) in first or second complete remission. Complete remission (CR) must have been achieved after no more than 2 cycles of induction/re-induction chemotherapy. Patients in first CR may have received no more than 1 cycle of consolidation therapy. Patients in second CR should proceed to transplant without further consolidation. No more than 6 months can have elapsed from CR to transplant
  3. Must not have M3-AML in first CR, acute leukemia following blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease, AML with t(8:21) in first CR, M4Eo-AML with inv 16 in first CR, diagnosis of myelodysplastic syndrome for more than 3 months prior to diagnosis of AML or patients with treatment-related AML
  4. Must not have had a prior transplant
  5. Must not have an allergy to iron dextran or murine proteins
  6. Patients must have a 6/6 HLA antigen (A, B, DRB1)-compatible sibling donor for entry on this protocol
  7. Karnofsky performance status > 70%
  8. Patients must have normal heart, lung, liver and kidney function
CONTACT Thelma Vawters (216) 844-8146 
TITLE E 1402: Study of Reduced Intensity (Nonmyeloablative) Allogenic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin’s and Hodgkin’s Lymphoma
DESCRIPTION

This study will examine the outcome of the nonmyeloablative transplant regimen with respect to side effects, safety, engraftment (the body’s acceptance of the transplanted cells), and overall and disease-free survival compared to the standard transplant approach. The study involves a combination of treatments. The preparative regimen is the experimental part of the bone marrow transplant (and this study) and consists of:

  • Photopheresis, a form of therapy in which UVADEX (brand name of the drug liquid methoxsalen) is injected into the blood, exposing the blood cells to ultraviolet light; 

  • Chemotherapy, whereby Pentostatin (a drug) is injected to target a type of white blood cell (a T-cell) that is involved in transplant acceptance or rejection; and 

  • Total Body Irradiation 

ELIGIBILITY
  1. Have either non-Hodgkin’s lymphoma or Hodgkin’s disease that has relapsed following a course of high dose chemotherapy and autologous stem cell transplantation OR have failed to mobilize adequate stem cells to undergo autologous stem cell transplant;
  2. Be greater than or equal to 90 days from prior transplant; 
  3. Be matched to a compatible donor;
  4. Be 18 years of age or older;
  5. Have at least one measurable or evaluable (able to be evaluated) disease parameter;
  6. Not be HIV positive;
  7. Meet minimum requirements for adequate performance status; and lung, heart, kidney, and liver function; and
CONTACT Thelma Vawters (216) 844-8146 
TITLE CTN 0302: Initial Systemic Treatment of Acute GVHD: A Phase II Randomized Trial Evaluating Etanercept, Mycophenolate Mofetil (MMF), Denileukin Diftitox (Ontak), and Pentostatin in Combination with Corticosteroids
DESCRIPTION

This research study is being conducted with patients who have a new diagnosis of graft-versus-host disease (GVHD) after receiving an allogeneic (donor -- the person who gave the stem cells for the transplant) stem cell transplant. Sometimes, GVHD can be controlled with treatments that use corticosteroids (like prednisone). More often, patients need long-term drug therapy to control their GVHD symptoms and to suppress the immune system. Because of the risks of continued GVHD, four new drugs to control GVHD are being tested in this study:

  1. Etanercept (also known as Enbrel)

  2. Mycophenolate Mofetil (MMF) (also known as Cellcept)

  3. Denileukin Diftitox (also known as Ontak)

  4. Pentostatin (also known as Nipent)

    All patients in the study will be randomly assigned to receive one of the four new study drugs. 

ELIGIBILITY
  1. Have had a prior allogenic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative transplants are also eligible;
  2. Be acute GVHD requiring systemic therapy within 24 hours of diagnosis;
  3. Be 10 years of age or older;
  4. Meet minimum requirements for clinical status and organ function; 
CONTACT Thelma Vawters 216-844-8146 
TITLE AMD 1404: A Multicenter, Randomized, Double Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 ug/kg) Plus G-CSF (10 ug/kg) versus G-CSF (10 ug/kg) plus Placebo to Mobilize and Collect > or Equal to 5 X 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
DESCRIPTION

This study is intended to determine whether the combination of AMD3100 with G-CSF is better than G-CSF alone in making more stem cells available for transplant to patients being treated for non-Hodgkin’s lymphoma. 
Patients choosing to participate in the study will receive the standard treatment for collecting stem cells which consists of daily injections of G-CSF each morning for four days in a row. On the 4th day, patients will receive either normal saline (placebo) or the study drug AMD3100 given as a subcutaneous (under the skin) injection. Patients will then return to the clinic the following morning to have the 5th morning dose of G-CSF. At that time stem cells will be collected, and, if enough are collected then, the experimental portion of the study will end and the patient will proceed with the routine transplant. If enough stem cells cannot be collected following the fifth morning dose of G-CSF (the first day of collection), the patient will continue receiving G-CSF in the morning and AMD3100 or placebo in the evening. This procedure will continue until the required amount of stem cells is collected, for a maximum of 4 collections. If the patient fails to collect an adequate number of cells, the treatment on this protocol will be stopped but the patient will have the option to go into another treatment in this protocol with G-CSF and AMD3100. The investigating doctor will discuss treatment options available to those who repeat the mobilization phase.

ELIGIBILITY
  1. A biopsy-confirmed diagnosis of NHL (all types excluding chronic lymphocytic leukemia)
  2. Eligible for autologous transplantation
  3. In first or second complete remission or partial remission
  4. Not received their last cycle of chemotherapy within the preceding four-week period (Rituxan® is not considered chemotherapy for the purpose of this study) 
  5. An ECOG performance scale of 0 or 1 
  6. Recovered from all acute toxic effects of prior chemotherapy
  7. Adequate bone marrow, liver, kidney, heart and lung function
CONTACT Donna Kane, RN (216) 844-8123
TITLE CWRU 3Y03: Donor Mesenchymal Stem Cell (MSC) Infusion For Treatment of Graft Versus Host Disease: A Phase I Trial
DESCRIPTION This study will determine the safety of donor MSC infusion in the setting of acute or chronic GVHD. Patients with acute GVHD will be treated with systemic corticosteroids with concurrent cyclosporine or FK506 to achieve therapeutic serum levels. Patients who develop de novo extensive chronic GVHD will be initiated on systemic corticosteroids in addition to other conventional immunosuppressive agents per treating physician. Within the first 72 hours of GVHD therapy, patients will be given HLA-identical donor MSCs intravenously over 10-15 minutes.
ELIGIBILITY
  1. Patients scheduled to undergo HLA-identical sibling donor allogeneic hematopoietic stem cell transplantation for any indication, malignant or non-malignant.
  2. Patients may be enrolled on institutional allogeneic stem cell transplant protocols using both ablative and non-myeloablative preparative regimens.
  3. Patients may not be enrolled on institutional allogeneic stem cell transplant protocols investigating GVHD prophylaxis or treatment.
  4. Patients who develop acute GVHD of clinical grade II-IV that requires systemic immunosuppressive therapy with systemic corticosteroids with concurrent Cyclosporine or FK506 are eligible.
  5. Patients who develop de novo extensive chronic GVHD that requires systemic immunosuppressive therapy that includes systemic corticosteroids are eligible.
  6. Patients with evidence of relapsed or progressive malignant disease at the time of GVHD are not eligible.
CONTACT 216-844-8146 
TITLE CTN 0201: A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell (PBSC) with Marrow Transplantation from HLA Compatible Unrelated Donors
DESCRIPTION This study will compare two-year survival of patients who have received PBSC to those who have received bone marrow transplantation. Patients will receive either PBSC or bone marrow from HLA matched unrelated donors after a standard preparative regimen for PBSC or bone marrow transplantation.
ELIGIBILITY
  1. Patients must have one of the following hematologic malignancies: AML, ALL, CML, Myelodysplastic syndrome, or Myeloproliferative disease.
  2. Patients with prior allogeneic or autologous transplants using any hematopoietic stem cell source are not eligible.
  3. Patients must have normal lung function.
  4. Patients must have normal liver and kidney function.
CONTACT 216-844-8146 
TITLE CTN 0102: A Trial of Tandem Autologous Stem Cell Transplants Plus or Minus Post Second Autologous Transplant Maintenance therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-Myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma
DESCRIPTION This trial will compare the progression-free survival at three years between patients enrolled on the two arms of the study. Patients will receive high-dose Melphalan plus Autologous peripheral blood stem cell transplant. Patients with an eligible HLA-matched sibling donor will receive a non-myeloablative allogeneic peripheral blood stem cell transplant between 60 and 120 days after the autologous transplant. Patients without an HLA-matched sibling donor will receive High-dose Melphalan plus a second autologous peripheral blood stem cell transplant. 
ELIGIBILITY
  1. Patients must have symptomatic stage II or III multiple myeloma requiring treatment.
  2. Patients 70 years of age or younger are eligible.
  3. Patients must have received at least three months of initial systemic therapy and be within 3 to 9 months of initiation of that therapy (this time frame excludes the time for mobilization chemotherapy).
  4. Patients must have adequate cardiac, liver, kidney and lung function.
  5. Patients must not have received prior allogeneic or autologous peripheral stem cell transplant.
CONTACT 216-844-8146 
TITLE CWRU 6Y01: A Pilot Study of the Safety and Feasibility of Multiple Umbilical Cord Blood (UCB) Unit Transplants Following Non-Myeloablative Conditioning Regimens in Paitients with Hematologic Malignancies or Severe Aplastic Anemia
DESCRIPTION The purpose of the study is to determine if there is less harm from this new treatment regimen (“non-ablative”) which uses lower doses of chemotherapy before the transplantation, results in engraftment of a new hematopoietic system, and the safety and speed of engraftment. Vigorous supportive therapies will be given while waiting for the cells to regrow in the bone marrow.
ELIGIBILITY
  1. Recurrent hematologic malignancies or sever aplastic anemia
  2. No available HLA-matched sibling
  3. Cannot receive myeloablative conditioning regimens due to advanced age and/or co-morbid conditions
  4. Karnofsky Performance Status >70% for adults and >50% for <16 years
  5. Adequate organ function 
  6. HIV Negative
  7. No acute leukemia in refractory relapse or primary myelofibrosis
  8. No active central nervous system leukemia
CONTACT   216-844-8146 
TITLE CWRU 1Y00: Hematopoietic Stem Cell Transplantation Using Bone Marrow or Peripheral Blood Stem Cells from Matched Unrelated Donors
DESCRIPTION This study will formalize an approach to stem cell transplantation with matched unrelated donor cells for hematologic malignancies and assess the toxicity, relapse rate, and survival rate after matched, unrelated stem cell transplantation.
ELIGIBILITY
  1. Histologic confirmation of AML, high risk ALL, CML, myelodysplastic syndromes, lymphoma (intermediate or high grade)
  2. 55 years old or younger
  3. ECOG performance status of 2 or less
  4. No evidence of active infection; HIV negative
  5. No significant cardiac or renal disease
  6. Adequate pulmonary and liver function
  7. No stem cell transplant during the previous year
CONTACT 216-844-8146 
TITLE S 9704: A Randomized Phase III Trial comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy (with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin's Lymphoma in the High Intermediate and High Risk International Classification Prognostic Groups
DESCRIPTION Induction chemotherapy followed by chemotherapy with or without radiation followed by stem cell infusion will be compared to the standard treatment of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).
ELIGIBILITY

 

  1. No evidence of central nervous system involvement
  2. No prior chemotherapy for lymphoma except for a single course of CHOP chemotherapy
  3. No prior radiation therapy
  4. Over 15 years of age but not have reached the 66th birthday
  5. Good general medical condition
  6. No significant coronary artery disease, cardiomyopathy, congestive heart failure or dysrhythmia
CONTACT 216-844-8146 
TITLE E 2993: Phase III Randomized Trial of Autologous and Allogeneic Bone Marrow Transplantation versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission.
DESCRIPTION The study involves the use of chemotherapy (Daunorubicin, Vincristine, Prednisone, L-asparaginase, and Methotrexate) to obtain a remission, followed by either conventional treatment with more chemotherapy or either autologous bone marrow transplant or allogeneic treatment.
ELIGIBILITY

 

  1. Previously untreated for malignancy
  2. Age 15-60 years old
  3. No intercurrent organ damage, psychiatric disorder, drug abuse, or pregnancy
  4. Must be HIV negative
  5. Performance status of 0 or 1
  6. Central nervous system negative for leukemia
  7. No significant cardiac disease
CONTACT 216-844-8146 
TITLE CWRU 4Y97: A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients with High Risk Malignancies
DESCRIPTION This study will determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing high dose chemo-radiotherapy followed by unrelated cord blood transplantation.
ELIGIBILITY

 

Patients with one of the following diagnoses are eligible:
  1. Patients with ANLL after induction failure, or in first complete remission with high risk features including stem cell or biphenotypic classification (AML-M0), erthroleukemia (AML-M6), acute megakaryocytic leukemia (AML-M7), cytogenetic markers indicative of poor prognosis, or failure to achieve complete remission after standard induction therapy.
  2. All patients with ALL or ANLL in second or subsequent remission.
  3. All patients with CML in chronic phase. CML patients with accelerated phase or blast crisis are eligible after reinduction chemotherapy places them in chronic phase.
  4. Patients with high risk ALL in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22), or t(8:14) translocation, or patients presenting with extreme hyperleukocytosis (initial WBC >500K/ml) or failure to achieve complete remission after standard induction therapy.
  5. Patients with myelodysplastic syndrome with evidence of evolution to AML, e.g., refractory anemia with excess blast (RAEB) or refractory anemia with excess blasts in transformation (RAEB-t).
  6. All patients with non-Hodgkin's lymphoma, ANLL or ALL with recurrent disease after autologous stem cell transplantation.

The Umbilical Cord Blood Registry will be searched to locate a suitable donor. Patients will be accepted as umbilical cord blood transplant candidates if they meet all of the following conditions:

  1. They do not have an HLA-ABC/DR identical related bone marrow or umbilical cord blood donor.
  2. They do not have a 5/6 antigen matched related bone marrow or umbilical cord blood donor.
  3. Their condition precludes waiting to search and find a donor in the National Marrow Donor Registry.
CONTACT 216-844-8146 
TITLE E 1900: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation:
DESCRIPTION

This study will compare disease-free survival (DFS) between two consolidation regimens: Gemtuzumab-ozogamicin followed by autologous peripheral blood stem cell (PBSC) transplant or directly to autologous transplant.  Patients will be randomized to one of two induction therapy arms.  Patients randomized to Arm A will receive Daunorubicin by IV injection over 10-15 minutes on days 1,2 and 3 and cytarabine by continuous IV infusion on days 1 through 7.  Patients randomized to Arm B will receive high-dose daunorubicin by IV infusion over 10-15 minutes on days 1,2 and 3 and cytarabine by continuous IV infusion on days 1 through 7.  All patients will receive up to 2 cycles of induction therapy in the attempt to gain a complete remission.  Patients with appropriate donors who are considered poor risk for transplant will be allocated to allogeneic transplant.  Patients who do not meet the eligibility criteria for allogeneic transplant will be randomized to consolidation therapy and autologous transplant. 

ELIGIBILITY

 

  1. Patients must have acute myeloid leukemia (AML) with evidence of CD33 positivity by flow cytommetry.

  2. Patients must not have been previously treated with radiation therapy or cytotoxic chemotherapy.   Previous therapy with corticosteroids or hydroxyurea will not exclude the patient.

  3. Patients must have adequate bone marrow, cardiac, hepatic and renal function.

  4. Patients must not have had blastic transformation of chromic myelogenous leukemia or secondary AML.  AML, which has evolved within 6 months from myelodysplastic syndrome (MDS), will be allowed.

  5. Patients must attain a complete remission after up to two cycles of induction therapy to continue protocol treatment.

CONTACT  Thelma Vawters 216-844-8146 
 

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