NCT00569309 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2018-03-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Experiencing Immune Reconstitution

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outcome · POSTED

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)

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outcome · POSTED

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

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outcome · POSTED

Quality of Life, Including Brief Pain Inventory

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outcome · POSTED

Quality of Life, Including Fatigue

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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 Names
Biological: Streptococcus pneumoniae
Other: laboratory correlative studies
Other: quality-of-life assessment
label
Prevnar
type
EXPERIMENTAL

interventions

arm Group Labels
Prevnar
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)
name
Streptococcus pneumoniae
other Names
Prevnar
PCV7
type
BIOLOGICAL
arm Group Labels
Prevnar
description
Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
name
laboratory correlative studies
other Names
laboratory biomarker analysis
blood samples
type
OTHER
arm Group Labels
Prevnar
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.
name
quality-of-life assessment
other Names
QOL
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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
measure
Number of Participants Experiencing Immune Reconstitution
time Frame
Up to 2 years

secondary Outcomes

measure
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
measure
Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
time Frame
Up to 3 years
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.
measure
Quality of Life, Including Brief Pain Inventory
time Frame
Up to 3 years
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.
measure
Quality of Life, Including Fatigue
time Frame
Up to 3 years
measure
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

Full 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).

Source references