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NCT Number: NCT01233921

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant.

PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer

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Key information

Conditions

Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myeloid Leukemia in Remission Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blast Crisis Blastic Phase Chronic Myelogenous Leukemia Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Sezary Syndrome Splenic Marginal Zone Lymphoma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Multiple Myeloma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Tumor Virus Infections Vascular Diseases Virus Diseases de Novo Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

OBJECTIVES:

I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD).

II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.

OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not.

GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity.

GROUP 2: Patients do not receive palifermin.

After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Survival for more than 60 days after an allogeneic hematopoietic cell transplantation (HCT) with growth-factor mobilized blood cells
  • Current dose of prednisone at =< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment
  • Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study
  • Able and willing to give informed consent

Exclusion criteria

  • Presence of generalized rash involving more than 50% of the body surface
  • Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment
  • Any prior local irradiation to a field that included the thymus (total body irradiation is allowed)
  • History of thymectomy
  • Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen
  • Use of a graft depleted of T cells
  • Any evidence of recurrent or persistent malignancy after HCT
  • Participation in another study with chronic GVHD as the primary endpoint
  • Any prior history of carcinoma
  • Any infection that is not improving during appropriate treatment
  • History of palifermin intolerance
  • A positive pregnancy test (women of child-bearing potential)
  • Breast feeding

Treatment and study plan

palifermin

Biological

Given IV

Other names: growth factor, recombinant human keratinocyte, Kepivance, keratinocyte growth factor, recombinant human, recombinant human keratinocyte growth factor, rhKGF

flow cytometry

Other

Correlative studies

laboratory biomarker analysis

Other

Correlative studies

pharmacological study

Other

Correlative studies

Other names: pharmacological studies

Primary outcomes

  1. Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood

    Time frame: Baseline and 4 weeks after administration of palifermin

    RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.

Secondary outcomes

  1. Changes in the Number of Naive CD4 T Cells in the Blood

    Time frame: Baseline and 4 weeks after administration of palifermin

    Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.

Sponsors and collaborators

Lead sponsor

Martin, Paul

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease

Important dates

Study start
2010
Primary completion
2012
First posted
Nov 3, 2010
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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