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Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00569309
First received: December 6, 2007
Last updated: October 13, 2016
Last verified: October 2016
  Purpose

RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer cells that remain after transplant.

PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients who have undergone autologous stem cell transplant for high-risk lymphoma or multiple myeloma.


Condition Intervention
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Small Intestine Cancer
Biological: Streptococcus pneumoniae
Other: laboratory correlative studies
Other: quality-of-life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Immune reconstitution [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serial assessment of the absolute number of circulating regulatory T-cells and the function of these cells as measured by their expression of TGFβ and interleukin-10 (IL-10) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Quality of life, including functional status, fatigue, and depression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Correlation of quality of life with inflammatory cytokine production of peripheral blood monocytes [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Collection of baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2007
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevnar
The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.
Biological: Streptococcus pneumoniae
Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
Other Names:
  • Prevnar
  • PCV7
Other: laboratory correlative studies
Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
Other Names:
  • laboratory biomarker analysis
  • blood samples
Other: quality-of-life assessment
Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.
Other Name: QOL

Detailed Description:

OBJECTIVES:

Primary

  • Assess immune reconstitution as measured by response to pneumococcal polyvalent vaccine, NK-cell activity against autologous lymphoblastoid cell lines, and cytomegalovirus and Epstein-Barr virus tetramer responses in patients who have undergone autologous hematopoietic stem cell transplantation for high-risk lymphoma or multiple myeloma.

Secondary

  • Assess the absolute number of circulating regulatory T-cells and the function of these cells as measured by their expression of TGFβ and interleukin-10 (IL-10).
  • Evaluate the effect of conditioning therapy on quality of life, including functional status, fatigue, and depression, in these patients.
  • Correlate quality of life with inflammatory cytokine production of peripheral blood monocytes at specified time points.
  • Provide baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials.

OUTLINE: Patients receive pneumococcal polyvalent vaccine intramuscularly once in weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation.

Blood samples are collected periodically for correlative and immunological studies.

Quality of life (QOL) is assessed periodically using the QOL short form (SF-36, 4-week version), the Center for Epidemiologic Studies Depression scale (CES-D), and the Multidimensional Fatigue Symptom Inventory (MFSI-30).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma OR any of the following high-risk lymphomas:

    • Diffuse large B-cell lymphoma meeting any of the following criteria:

      • Failed induction therapy but responded to salvage therapy
      • Relapsed < 1 year after completion of induction therapy
      • Elevated lactic dehydrogenase (LDH) at relapse
      • Stage III or IV disease at relapse
      • Positive PET scan after induction or salvage therapy
      • Age 60 to 75 years
    • Follicular lymphoma meeting any of the following criteria:

      • Progressive disease after two or more prior regimens
      • Transformed to aggressive diffuse large B-cell lymphoma but is still chemotherapy sensitive
      • Not considered to be a good candidate for allogeneic stem cell transplantation
    • Hodgkin lymphoma meeting any of the following criteria:

      • Primary refractory disease
      • Relapsed < 1 year after completion of induction therapy
      • Relapsed with PET positive disease after salvage therapy
      • Relapsed refractory disease and is not considered to be a good candidate for allogeneic stem cell transplantation
    • Mantle cell lymphoma meeting any of the following criteria:

      • Chemotherapy sensitive disease after induction therapy
      • Chemotherapy sensitive relapsed disease and is not considered to be a good candidate for allogeneic stem cell transplantation
    • T-cell non-Hodgkin lymphoma (NHL) meeting any of the following criteria:

      • Peripheral T-cell lymphoma, not otherwise specified meeting at least one of the following criteria:

        • High LDH at diagnosis
        • Marrow involvement at diagnosis
        • Age > 60 years at diagnosis
        • Low platelet count at diagnosis
        • Chemotherapy sensitive relapsed disease
      • Angioimmunoblastic lymphadenopathy with dysproteinemia
      • ALK-negative anaplastic NHL
      • Enteropathy-associated T-cell NHL
      • Stage III or IV NK-/T-cell NHL at diagnosis
      • NK-blastic NHL
  • Has undergone autologous hematopoietic stem cell transplantation and received 200 mg/m² of melphalan (for multiple myeloma) OR BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and methotrexate (for high-risk lymphoma) as conditioning therapy

PATIENT CHARACTERISTICS:

  • ECOG or WHO performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 75,000/μL
  • Total bilirubin ≤ 1.5 mg/dL
  • Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times the ULN
  • Not pregnant or nursing
  • No severe or uncontrolled systemic illness
  • No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Patients are not considered to have a "currently active" malignancy if they completed therapy for the malignancy, are disease free from the malignancy for > 5 years, and are considered by their physician to be at < 30% risk of relapse
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Recent myocardial infarction (within the past 6 months)
    • Uncontrolled congestive heart failure
  • No active bacterial, fungal, or viral infection
  • No known HIV infection or active hepatitis B and/or hepatitis C infection
  • No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results

PRIOR CONCURRENT THERAPY:

  • No concurrent biologic therapy, chemotherapy, or other antineoplastic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569309

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Craig Hofmeister
Investigators
Principal Investigator: Craig C. Hofmeister, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00569309     History of Changes
Other Study ID Numbers: OSU-07044 
Study First Received: December 6, 2007
Last Updated: October 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent adult Hodgkin lymphoma
stage I multiple myeloma
stage II multiple myeloma

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016