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

Primary Purpose

Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Small Intestine Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Streptococcus pneumoniae
laboratory correlative studies
quality-of-life assessment
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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, stage III multiple myeloma, refractory multiple myeloma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, adult nasal type extranodal NK/T-cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, small intestine lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevnar

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Immune Reconstitution
Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma

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)
Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
Quality of Life, Including Brief Pain Inventory
The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
Quality of Life, Including Fatigue
Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials

Full Information

First Posted
December 6, 2007
Last Updated
March 8, 2018
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00569309
Brief Title
Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
Official Title
Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2007 (Actual)
Primary Completion Date
July 29, 2011 (Actual)
Study Completion Date
July 29, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Small Intestine Cancer
Keywords
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, stage III multiple myeloma, refractory multiple myeloma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, adult nasal type extranodal NK/T-cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, small intestine lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevnar
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Streptococcus pneumoniae
Other Intervention Name(s)
Prevnar, PCV7
Intervention Description
Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
Intervention Type
Other
Intervention Name(s)
laboratory correlative studies
Other Intervention Name(s)
laboratory biomarker analysis, blood samples
Intervention Description
Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
QOL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Immune Reconstitution
Description
Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
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
Title
Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
Time Frame
Up to 3 years
Title
Quality of Life, Including Brief Pain Inventory
Description
The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.
Time Frame
Up to 3 years
Title
Quality of Life, Including Fatigue
Description
Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.
Time Frame
Up to 3 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig C. Hofmeister, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

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

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