N/A
Completed N=30
Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
Source: ClinicalTrials.gov NCT00569309 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants Experiencing Immune Reconstitution — 30 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Immune Reconstitution |
30 | — |
| 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) |
— | — |
| SECONDARY Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes |
— | — |
| SECONDARY Quality of Life, Including Brief Pain Inventory |
2.8 | — |
| SECONDARY Quality of Life, Including Fatigue |
2.55 | — |
| SECONDARY Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00569309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.