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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00569309
Enrollment
30
Registered
2007-12-07
Start date
2007-12-12
Completion date
2011-07-29
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

BIOLOGICALStreptococcus 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)

OTHERlaboratory correlative studies

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

OTHERquality-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.

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Experiencing Immune ReconstitutionUp to 2 yearsImmune 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

MeasureTime frameDescription
Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy TrialsUp to 3 years
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)Up to 3 years
Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood MonocytesUp to 3 years
Quality of Life, Including Brief Pain InventoryUp to 3 yearsThe 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 FatigueUp to 3 yearsBrief 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G.
30
Total30

Baseline characteristics

CharacteristicPrevnar
Age, Continuous51 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
26 Participants
Region of Enrollment
United States
30 Participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
30 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

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

Time frame: Up to 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PrevnarNumber of Participants Experiencing Immune Reconstitution30 Participants
Secondary

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

Population: Data was not collect and analyzed for reporting purposes

Secondary

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

Time frame: Up to 3 years

Population: Quality of Life surveys were not completed

Secondary

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.

Time frame: Up to 3 years

Population: Not all patients data was available due to incomplete surveys

ArmMeasureValue (MEAN)Dispersion
PrevnarQuality of Life, Including Brief Pain Inventory2.8 units on a scaleStandard Deviation 2.1
Secondary

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.

Time frame: Up to 3 years

ArmMeasureValue (MEAN)Dispersion
PrevnarQuality of Life, Including Fatigue2.55 units on a scaleStandard Deviation 2.21
Secondary

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

Population: Inadequate material collected to perform these assays

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026