A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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