Hematological Malignancies Clinical Trial
Official title:
A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
Verified date | May 2018 |
Source | Barbara Ann Karmanos Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of the study is to determine the incidence and severity of acute Graft
versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor
Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the
combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will
determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets
(engraftment), determining the occurrence of opportunistic infections, defined as infection
that occurs in people with weakened immune systems and caused by organisms that do not
normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral
infections), estimating the incidence of chronic GVHD at two years and the overall and
disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at
various points after transplant.
Status | Completed |
Enrollment | 21 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Suitable related donor as determined by the treating physician - High resolution molecular HLA typing is mandatory for HLA Class I and II - Diagnosis of hematological malignancy - Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol: - Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR) - Hodgkin disease, any CR/PR/stable disease (SD) - Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/µl on the day of initiation of conditioning - Myelodysplastic syndrome (MDS), treated or untreated - Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase - Chronic myelomonocytic leukemia (CMML) - Multiple myeloma, any CR/PR/SD - Chronic lymphocytic leukemia (CLL) any CR/PR - Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning - Age >= 18 and able to cooperate with oral medication intake - Filgrastim (G-CSF) mobilized Peripheral blood stem cells - Agrees to participate, and informed consent signed - Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Creatinine clearance > 60 mL/min - Ejection fraction > 50% - Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal - Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted Exclusion Criteria: - Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc) - Patients with documented uncontrolled central nervous system (CNS) disease - Active donor or recipient serology positive for human immunodeficiency virus (HIV) - Known contraindication to administration of Tacrolimus or Thymoglobulin - Active Hepatitis B or C - Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator - Oxygen usage at the time of enrollment - Patients with clinical ascites - Women who are pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Barbara Ann Karmanos Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Acute GVHD | Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks | Assessed first 6 months post transplant | |
Primary | Safety Defined by Serious Adverse Events | Counted the number of participants that experienced any type of grade 3 or higher toxicity. | Assessed first 6 months post transplant | |
Primary | Severity of Acute GVHD | Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks | Assessed first 6 months post transplant | |
Secondary | Determine Incidence of Opportunistic Infections | Followed for up to two years post transplant | ||
Secondary | Estimate Incidence of Chronic GVHD at Two Years | Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks | Followed for up to two years post transplant | |
Secondary | Overall Survival at Two Year, | Followed for up to two years post transplant | ||
Secondary | Determine Time to Engraftment ("G500") | The number of days until engraftment ("G500") | Followed for up to two years post transplant | |
Secondary | Determine Time to Engraftment ("PLT20") | The number of days until engraftment ("PLT20") | Followed for up to two years post transplant |
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