Host Dendritic Cells in Allograft Patients
Status unconfirmed · Phase 1
Conditions studied: Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma
In brief
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.
Key facts
- Study ID
- NCT00935597
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 25
- Starts
- 2009-08-01
- Last updated by the study team
- 2010-10-29
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-70
- Ability to sign informed consent
- ECOG performance status ≤3
- Life expectancy > 6 months
- Adequate cardiac function: MUGA or Echocardiogram demonstrating >50% Ejection Fraction
- Adequate pulmonary function with DLCO > 50%
- Adequate hepatic function
- Bilirubin ≤ 1.5mg/dl
- Alkaline phosphatase ≤5 times the upper limit of normal
- Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transferase (SGOT) ≤ 3 times the upper limit of normal
- Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≤ 3 times the upper limit of normal
- Adequate renal function Estimated creatinine clearance > 40ml/min
- Diagnosis of one of the following
- Non-Hodgkin's lymphoma excluding Follicular lymphoma and Marginal Zone Lymphoma
- Hodgkin's lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- Eligible for allogeneic stem cell transplant with identified HLA-identical sibling (6/6 HLA match) or volunteer unrelated donor (8/8 allele HLA-matched (A, B, Cw, DRB1)
- Women of childbearing potential must have a negative serum pregnancy test prior to enrollment
- Women of childbearing potential must use effective means of birth control throughout the study.
- Men should not father a child while enrolled in the study. Effective means of birth control include condom, vasectomy or abstinence.
You may not qualify if…
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
- Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study.
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
- More than 4 prior relapses
- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
- No cytotoxics will be given within 4 weeks of administration of the investigational cell therapy
- Patients cannot receive any investigational agents within 30 days prior to administration of the investigational cell therapy
Where it is running
- Mount Sinai Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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