Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|ClinicalTrials.gov Identifier: NCT02877082|
Recruitment Status : Terminated
First Posted : August 24, 2016
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Diffuse Large B-Cell Lymphoma Follicular Lymphoma Graft Versus Host Disease Mantle Cell Lymphoma Marginal Zone Lymphoma Myelodysplastic Syndrome Myelofibrosis Myeloproliferative Neoplasm Small Lymphocytic Lymphoma||Biological: Thymoglobulin Drug: Bortezomib Drug: Tacrolimus||Phase 2|
I. To determine a composite end point of alive and severe acute GVHD free at 6 months following human leukocyte antigen (HLA) matched related or unrelated donor hematopoietic peripheral blood transplant in patients with hematologic malignancies who receive the immunosuppressive combination tacrolimus, bortezomib, anti-thymocyte globulin (TBT) as GVHD prophylaxis.
II. To determine the safety of this combination in the first six months post-transplant.
I. To determine the cumulative incidence of grade III-IV aGVHD.
II. To determine incidence and severity of chronic GVHD.
III. To determine disease relapse or progression overall and disease free survival at one year.
Patients receive tacrolimus intravenously (IV) on day -3 through day 180. Patients may receive tacrolimus orally (PO) later at the doctor's discretion. Patients receive anti-thymocyte globulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.
After completion of study treatment, patients are followed up for 6 months and then periodically for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Low Toxicity GVHD Prevention and Enhanced Immune Recovery With Tacrolimus, Bortezomib and Thymoglobulin® TBT|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Experimental: Tacrolimus, bortezomib, thymoglobulin
Patients receive tacrolimus IV on day -3 through day 180. Patients may receive tacrolimus PO later at the doctor's discretion. Patients receive thymoglobulin IV on days -3, -2, and -1 and bortezomib IV on day 0 and day 3. Patients undergo allogeneic bone marrow transplant on day 0.
Given IV and PO
- Total Number of Serious Adverse Events and Adverse Events Related to This Immunosuppressive Regimen [ Time Frame: Up to 6 months post-transplant ]
An adverse event (AE) is defined as any untoward medical experience or change of an existing condition that occurs during or after treatment. All AEs occurring during this study, whether observed by the physician, nurse, or reported by the patient, will be graded per NCI CTCAE version 4.0 and recorded on protocol-specific case report forms. A serious adverse event (SAE) is defined as any expected or unexpected adverse event (AE, generally equivalent to CTCAE grades 3, 4 or 5) that results in any of the following outcomes:
- Life-threatening event
- In-patient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization
- Persistent or significant disability/incapacity
- Congenital anomaly/birth defect
- Number of Patients Alive and Free of Severe Acute GVHD Following HLA Matched Related or Unrelated Donor Hematopoietic Peripheral Blood Transplant [ Time Frame: At 6 months post-transplant ]Will use patient counts for the number of patients alive and free of severe acute graft versus host disease (GVHD) following human leukocyte antigen (HLA) matched related or unrelated donor hematopoietic peripheral blood transplant.
- Cumulative Incidence of Grade III-IV aGVHD [ Time Frame: Up to 2 years post-transplant ]Will be summarized as percentage and 95% confidence level will be also constructed.
- Incidence of Chronic GVHD [ Time Frame: Up to 2 years post-transplant ]Will be summarized as percentage and 95% confidence level will be also constructed.
- Overall Survival [ Time Frame: At 1 year post-transplant ]Will be analyzed with Kaplan Meier method and Logrank test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877082
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Zaid Al-Kadhimi, MD||Emory University/Winship Cancer Institute|