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

Martin, Paul

Status: Completed

Conditions: Stage IV Small Lymphocytic Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Chronic Neutrophilic Leukemia; Splenic Marginal Zone Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Chronic Eosinophilic Leukemia; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Adult Acute Myeloid Leukemia in Remission; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Stage III Grade 3 Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Recurrent Mantle Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Stage I Multiple Myeloma; Blastic Phase Chronic Myelogenous Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Chronic Myelomonocytic Leukemia; Stage III Adult Immunoblastic Large Cell Lymphoma; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Stage III Adult Diffuse Large Cell Lymphoma; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Recurrent Small Lymphocytic Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Accelerated Phase Chronic Myelogenous Leukemia; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Stage III Multiple Myeloma; Stage III Marginal Zone Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Noncontiguous Stage II Adult Burkitt Lymphoma; Chronic Phase Chronic Myelogenous Leukemia; Refractory Hairy Cell Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Recurrent Adult Hodgkin Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Refractory Multiple Myeloma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Previously Treated Myelodysplastic Syndromes; Relapsing Chronic Myelogenous Leukemia; Recurrent Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Stage IV Grade 3 Follicular Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Stage III Small Lymphocytic Lymphoma; Adult Acute Myeloid Leukemia With Del(5q); Stage IV Adult Diffuse Large Cell Lymphoma; de Novo Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Stage IV Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Adult Acute Lymphoblastic Leukemia in Remission; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Secondary Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Noncontiguous Stage II Grade 3 Follicular Lymphoma; Graft Versus Host Disease; Stage IV Adult Burkitt Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Primary Myelofibrosis; Secondary Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage II Multiple Myeloma

Treatments: Other: pharmacological study; Biological: palifermin; Other: flow cytometry; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01233921

NCI-2010-01711 (Registry Identifier)

2437.00

Details and patient eligibility

About

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

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Arm I (palifermin)

Experimental group

Description:

Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.

Treatment:

Other: flow cytometry

Biological: palifermin

Other: laboratory biomarker analysis

Other: pharmacological study

Arm II (no palifermin)

Active Comparator group

Description:

Patients do not receive palifermin.

Treatment:

Other: flow cytometry

Other: laboratory biomarker analysis

Other: pharmacological study