Host Dendritic Cells in Allograft Patients



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 70
Updated:4/2/2016
Start Date:August 2009
Contact:Keren Osman, MD
Email:keren.osman@mssm.edu
Phone:(212)241-6021

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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

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.


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
We found this trial at
1
site
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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mi
from
New York, NY
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