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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569309
• Other study ID #: OSU-07044
• Status: Completed
• Phase: N/A
• First received: December 6, 2007
• Last updated: March 8, 2018
• Start date: December 12, 2007
• Est. completion date: July 29, 2011

Study information

• Verified date: March 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 29, 2011
• Est. primary completion date: July 29, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Neoplasms
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma
• Small Intestine Cancer

Intervention

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:
• 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. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Up to 2 years
Secondary	Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFß and Interleukin-10 (IL-10)		Up to 3 years
Secondary	Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes		Up to 3 years
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.	Up to 3 years
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.	Up to 3 years
Secondary	Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials		Up to 3 years

External Links

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