TriangleNCT01246206 · REGISTRY CONDITION SEARCH
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2018-06-18
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Incidence of Acute GVHD
Safety Defined by Serious Adverse Events
Severity of Acute GVHD
Determine Incidence of Opportunistic Infections
Estimate Incidence of Chronic GVHD at Two Years
Overall Survival at Two Year,
Determine Time to Engraftment ("G500")
Determine Time to Engraftment ("PLT20")
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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 \< 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
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
- intervention Names
- Drug: Tacrolimus and Thymoglobulin
- label
- Tacrolimus and Thymoglobulin
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Tacrolimus and Thymoglobulin
- description
- Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
- name
- Tacrolimus and Thymoglobulin
- other Names
- PROGRAF®
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 21
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
- measure
- Incidence of Acute GVHD
- time Frame
- Assessed first 6 months post transplant
- description
- Counted the number of participants that experienced any type of grade 3 or higher toxicity.
- measure
- Safety Defined by Serious Adverse Events
- time Frame
- Assessed first 6 months post transplant
- description
- Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
- measure
- Severity of Acute GVHD
- time Frame
- Assessed first 6 months post transplant
- secondary Outcomes
- measure
- Determine Incidence of Opportunistic Infections
- time Frame
- Followed for up to two years post transplant
- description
- Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks
- measure
- Estimate Incidence of Chronic GVHD at Two Years
- time Frame
- Followed for up to two years post transplant
- measure
- Overall Survival at Two Year,
- time Frame
- Followed for up to two years post transplant
- description
- The number of days until engraftment ("G500")
- measure
- Determine Time to Engraftment ("G500")
- time Frame
- Followed for up to two years post transplant
- description
- The number of days until engraftment ("PLT20")
- measure
- Determine Time to Engraftment ("PLT20")
- time Frame
- Followed for up to two years post transplant
Full study description
- brief 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.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice