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LymphomaNCT00569309

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

A study testing Streptococcus pneumoniae, laboratory correlative studies and quality-of-life assessment in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Streptococcus pneumoniae, laboratory correlative studies and quality-of-life assessment
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Dec 2007to 29 Jul 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma

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.

Read the 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).

Being tested
Streptococcus pneumoniae, laboratory correlative studies, quality-of-life assessment
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
Medical subject headings
Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Hodgkin Disease, Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Streptococcus pneumoniaeBiological

    Also called Prevnar, PCV7

    Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)

  • laboratory correlative studiesOther

    Also called laboratory biomarker analysis, blood samples

    Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.

  • quality-of-life assessmentOther

    Also called QOL

    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.

Study groups in NCT00569309
Study groupRoleWhat they receive
PrevnarExperimentalThe 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.
Receives: Biological: Streptococcus pneumoniae; Other: laboratory correlative studies; Other: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 2 years

Secondary outcomes (5)

  1. 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)

    Measured: Up to 3 years

  2. Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes

    Measured: Up to 3 years

  3. 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.

    Measured: Up to 3 years

  4. 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.

    Measured: Up to 3 years

  5. Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2007 (estimated)
  2. Study start12 Dec 2007
  3. Primary completion29 Jul 2011
  4. Study completion29 Jul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569309
Sponsor's protocol ID
OSU-07044
Status last verified
Mar 2018
First submitted
6 Dec 2007
Last updated
12 Mar 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Streptococcus pneumoniae, laboratory correlative studies and quality-of-life assessment in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Immune Reconstitution (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.

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