T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases
NCT ID: NCT00589602
Last Updated: 2017-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
13 participants
INTERVENTIONAL
2004-01-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant followed by delayed T cell infusions in treating patients with hematologic cancer or other disease.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder, MS, AML, or CML
NCT00069992
Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
NCT00322101
Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
NCT00005801
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT01529827
Total Marrow and Total Lymph Node Irradiation, Fludarabine, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Hematological Cancer That Has Not Responded to Treatment
NCT00800150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Determine if T-cell depletion of a peripheral blood progenitor cell (PBPC) graft followed by delayed add-backs of defined doses of donor lymphocytes decreases the rate of graft-versus-host disease and its complications in matched unrelated donor (MUD) allogeneic peripheral blood progenitor cell (PBPC) transplantation in patients with hematologic cancers or other diseases.
* Determine whether targeted T-cell dosages in the PBPC graft can be achieved in these patients by positive CD34+ selection using the Baxter Inc. Isolex 300i v. 2.5.
* Determine the effects of T-cell depletion on the rate of engraftment in these patients.
* Develop a matched unrelated donor (MUD) allogeneic transplantation regimen that will decrease overall treatment-related mortality in these patients.
OUTLINE: This is a non-randomized study.
* Myeloablative preparative regimen: Patients receive cyclophosphamide IV once daily on days -5 and -4 followed by total body irradiation twice daily on days -3, -2, and -1. Patients also receive tacrolimus on day -1 administered by continuous IV infusion over 24 hours.
* Peripheral blood progenitor cell graft transplantation: Patients receive T-cell depleted, peripheral blood progenitor cells (PBPC) by IV infusion on day 0. Beginning 1 day after completion of the PBPC infusion, patients receive filgrastim (G-CSF) subcutaneously once daily until blood counts recover.
* Post transplantation T cell add-backs: Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in the absence of active graft-versus-host disease (GVHD) requiring steroids\*.
NOTE: \*A T cell add-back may be given in the presence of GVHD, if the investigator considers the risk from relapse or overwhelming viral infection to outweigh the risk of exacerbating GVHD.
Patients will be followed periodically for relapse and survival.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
T-Cell Depletion Transplant
Our protocol is designed to attempt to improve the current results of matched unrelated donor (MUD) allo bone marrow transplant (BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.
Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'
peripheral blood lymphocyte therapy
T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be \>0.5 x 105 but \<1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be \>2 x 106 cells/kg.
allogeneic hematopoietic stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
peripheral blood stem cell transplantation
Peripheral blood stem cell transplantation
total-body irradiation (TBI)
Treatment will be delivered using 6MV photons twice daily for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
peripheral blood lymphocyte therapy
T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be \>0.5 x 105 but \<1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be \>2 x 106 cells/kg.
allogeneic hematopoietic stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation
peripheral blood stem cell transplantation
Peripheral blood stem cell transplantation
total-body irradiation (TBI)
Treatment will be delivered using 6MV photons twice daily for 3 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cardiac ejection fraction \>45%. If less than 45%, a Cardiac consult will be obtained.
* A suitably matched unrelated donor that is at least a 7 out of 8 HLA serologic match.
* Patient is not pregnant.
* FEV 1 and DLCO \> 45% predicted on pulmonary function testing.
* Serum creatinine \<2.0 mg/dl, serum bilirubin \<2.0 mg/dl.
* Patient and donor are HIV negative.
* Diagnosis of one of the following diseases
* Acute myelogenous leukemia
* Relapsed disease,
* Refractory disease, or
* With poor-risk cytogenetics
* Acute lymphoblastic leukemia
* Relapsed disease,
* Refractory disease, or
* With poor-risk cytogenetics
* Chronic myelogenous leukemia
* Persistent disease after at least 6 months of treatment with Imatinib Mesylate (Gleevec)
* Myelodysplasia
* FAB Classification of RAEB or RAEB-T -Or-
* IPSS score \>2
* Lymphoid malignancies, including non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia and prolymphocytic leukemia
* Relapsed or refractory disease after at least 1 prior therapy
* Myelofibrosis
* Transfusion dependence (RBC's, platelets, or both)
* Paroxysmal Nocturnal Hemoglobinuria (PNH)
* Transfusion dependent
* Myeloproliferative Disorder
* Eosinophilic Leukemia
* Severe aplastic anemia (\<1% corrected reticulocyte count, \<30,000 untransfused platelet count, bone marrow biopsy with \<15% cellularity)
* Plasma cell leukemia
* Patients with ET or PV will not be candidates unless their disease has transformed to end stage myelofibrosis or acute leukemia, for which eligibility criteria for myelofibrosis or acute leukemia would apply.
* Patient must signed written informed consent.
Exclusion Criteria
* Absence of any of the above mentioned medical conditions
* Availability of matched-related donor
* History of prior allogeneic BMT
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jaroslaw Maciejewski
Department Chair of Translational Hematology and Oncology Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian J. Bolwell, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Jarek Maciejewski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCF-6501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.