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

NCT00569309 | Completed Results DMC

• 1 other identifier: OSU-07044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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

  Up to 2 years

Secondary Outcomes (5)

• 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 Monocytes

  Up to 3 years

• Quality of Life, Including Brief Pain Inventory

  Up to 3 years

• Quality of Life, Including Fatigue

  Up to 3 years

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

  Up to 3 years

Study Arms (1)

Prevnar

EXPERIMENTAL

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.

Biological: Streptococcus pneumoniae; Other: laboratory correlative studies; Other: quality-of-life assessment

Interventions

Streptococcus pneumoniae BIOLOGICAL

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

Also known as: Prevnar, PCV7

Prevnar

laboratory correlative studies OTHER

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

Also known as: laboratory biomarker analysis, blood samples

Prevnar

quality-of-life assessment OTHER

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.

Also known as: QOL

Prevnar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Hodgkin Disease; Lymphoma, Extranodal NK-T-Cell; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Craig Hofmeister, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Craig.Hofmeister@osumc.edu

614-293-9869

Study Officials

• Craig C. Hofmeister, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: December 12, 2007
• Primary Completion: July 29, 2011
• Study Completion: July 29, 2011
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-03

Locations

US (1)