Phase 2
N=21
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
Hematological Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT01246206 ↗Enrolled (actual)
21
Serious AEs
90.5%
Results posted
Jun 2017
Primary outcome: Primary: Incidence of Acute GVHD — 45.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tacrolimus and Thymoglobulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute GVHD |
45.0 | — |
| PRIMARY Safety Defined by Serious Adverse Events |
19 | — |
| PRIMARY Severity of Acute GVHD |
10.0 | — |
| SECONDARY Determine Incidence of Opportunistic Infections |
95.0 | — |
| SECONDARY Estimate Incidence of Chronic GVHD at Two Years |
75.0 | — |
| SECONDARY Overall Survival at Two Year, |
75.0 | — |
| SECONDARY Determine Time to Engraftment ("G500") |
11 | — |
| SECONDARY Determine Time to Engraftment ("PLT20") |
17 | — |
Summary
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.
Eligibility Criteria
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 = 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 = 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
Data sourced from ClinicalTrials.gov (NCT01246206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.