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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Small Intestine Cancer

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Trial Information

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


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).

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune reconstitution

Outcome Time Frame:

2007-present

Safety Issue:

No

Principal Investigator

Craig C. Hofmeister, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

OSU-07044

NCT ID:

NCT00569309

Start Date:

December 2007

Completion Date:

Related Keywords:

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

Name

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240