Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Pati... | NCT01246206

NCT01246206

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Tacrolimus and Thymoglobulin	Experimental	Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis	Drug: Tacrolimus and Thymoglobulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus and Thymoglobulin	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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 Outcomes

Measure	Description	Time Frame
Determine Incidence of Opportunistic Infections		Followed for up to two years post transplant
Estimate Incidence of Chronic GVHD at Two Years	Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks

Eligibility Module

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

Name	Affiliation	Role
Zaid Al-Kadhimi, M.D.	Barbara Ann Karmanos Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Barbara Ann Karmanos Cancer Institute		Detroit	Michigan	48201	United States

Arm/Group Information

ID	Title	Description
FG000	Tacrolimus and Thymoglobulin	Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Tacrolimus and Thymoglobulin	Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Acute GVHD

Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks

All participants

Posted

Number

95% Confidence Interval

percentage of participants

Assessed first 6 months post transplant

ID	Title	Description
OG000	Tacrolimus and Thymoglobulin	Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tacrolimus and Thymoglobulin	Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: 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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Alanine Aminotransferase increased	Investigations	CTCAE (3.0)	Systematic Assessment

Title	Organization	Phone	Extension	Email
Dr. Zaid Al-Kadhimi	Barbara Ann Karmanos Cancer Institute	800-527-6266		zalkadh@emory.edu

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D009190	Myelodysplastic Syndromes
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D009101	Multiple Myeloma
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D055728	Primary Myelofibrosis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

ID	Term
D016559	Tacrolimus
C512542	thymoglobulin