Clinical trial NCT00935597: Host Dendritic Cells in Allograft Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed Non-Hodgkin's Lymphoma
Hodgkin's Disease
Multiple Myeloma
Chronic Lymphocytic Lymphoma
Keywords: Relapsed Non-Hodgkin's Lymphoma
Hodgkin's Disease
Multiple Myeloma
Chronic Lymphocytic Lymphoma
Relapsed Non-Hodgkin's lymphoma (excluding follicular lymphoma and marginal zone lymphoma)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
timeFrame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
Secondary outcomes:
measure: The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism
timeFrame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Keren Osman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: