A Phase 2 interventional study of Thymoglobulin and Bortezomib in Acute Leukemia, Chronic Lymphocytic Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by Emory University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Emory University · Phase 2, Interventional, and Prevention
This phase II trial studies how well tacrolimus, bortezomib, and anti-thymocyte globulin (thymoglobulin) work in preventing low toxicity graft versus host disease (GVHD) in patients with blood cancer who are undergoing donor stem cell transplant. Tacrolimus and anti-thymocyte globulin may reduce the risk of the recipient's body rejecting the transplant by suppressing the recipient's immune system. Giving bortezomib after the transplant may help prevent GVHD by stopping the donor's cells from attacking the recipient. Giving tacrolimus, bortezomib, and anti-thymocyte globulin may be a better way to prevent low toxicity GVHD in patients with blood cancer undergoing donor stem cell transplant.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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Exclusion Criteria:
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.
Biological: Thymoglobulin · Drug: Bortezomib · Drug: Tacrolimus
Given IV
Also known as: Antithymocyte Globulin, Antithymocyte Serum, ATG, ATGAM, ATS, Anti-Thymocyte Globulin
Given IV
Also known as: LDP 341, MLN341, PS-341, PS341, Velcade
Given IV and PO
Also known as: FK 506, Fujimycin, Hecoria, Prograf, Protopic
Total Number of Serious Adverse Events and Adverse Events Related to This Immunosuppressive Regimen
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: * Death * 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 * Cancer * Overdose
Time frame: Up to 6 months post-transplant
Number of Patients Alive and Free of Severe Acute GVHD Following HLA Matched Related or Unrelated Donor Hematopoietic Peripheral Blood 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.
Time frame: At 6 months post-transplant
Cumulative Incidence of Grade III-IV aGVHD
Will be summarized as percentage and 95% confidence level will be also constructed.
Time frame: Up to 2 years post-transplant
Incidence of Chronic GVHD
Will be summarized as percentage and 95% confidence level will be also constructed.
Time frame: Up to 2 years post-transplant
Overall Survival
Will be analyzed with Kaplan Meier method and Logrank test.
Time frame: At 1 year post-transplant
Patients were recruited from 9/9/2016 to 7/11/2017 at Winship Cancer Institute of Emory University.
| Milestone | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Trial was closed early | 5 |
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: * Death * 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 * Cancer * Overdose
| events | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| Total Number of Serious Adverse Events and Adverse Events Related to This Immunosuppressive Regimen | 9 |
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.
| Participants | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| Number of Patients Alive and Free of Severe Acute GVHD Following HLA Matched Related or Unrelated Donor Hematopoietic Peripheral Blood Transplant | 1 |
Will be summarized as percentage and 95% confidence level will be also constructed.
No measurements were reported for this outcome.
Will be summarized as percentage and 95% confidence level will be also constructed.
No measurements were reported for this outcome.
Will be analyzed with Kaplan Meier method and Logrank test.
No measurements were reported for this outcome.
Collected over Adverse event data were collected up to 180 days post-transplant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tacrolimus, Bortezomib, Thymoglobulin | 2/5 (40%) | 4/5 (80%) | 0/5 (0%) |
| Event | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| DiarrheaGastrointestinal disorders | 2/5 |
| Thrombotic thrombocytopenic purpuraBlood and lymphatic system disorders | 1/5 |
| Device related infectionInfections and infestations | 1/5 |
| ConfusionPsychiatric disorders | 1/5 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/5 |
| Age, Categorical(Participants) | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| Female | 3 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Tacrolimus, Bortezomib, Thymoglobulin |
|---|---|
| United States | 5 |
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