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Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT

Information source: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematological Malignancies

Intervention: Tacrolimus and Thymoglobulin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Barbara Ann Karmanos Cancer Institute

Official(s) and/or principal investigator(s):
Zaid Al-Kadhimi, M.D., Principal Investigator, Affiliation: Barbara Ann Karmanos Cancer Institute

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.

Clinical Details

Official title: A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence and severity of acute GVHD

Safety defined by serious adverse events

Secondary outcome:

Determine incidence of opportunistic infections

Estimate incidence of chronic GVHD at two years

Overall and disease free survival at two year,

Assess immune response with immuno-correlative studies both pre and at various points post transplant.

Determine time to engraftment

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States
Additional Information

Starting date: November 2010
Last updated: May 15, 2014

Page last updated: August 23, 2015

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