Host Dendritic Cells in Allograft Patients

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00935597
• Other study ID #: 08-0906
• Status: Recruiting
• Phase: Phase 1
• First received: July 7, 2009
• Last updated: October 28, 2010
• Start date: August 2009

Study information

• Verified date: October 2010
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Keren Osman, MD
• Phone: (212)241-6021
• Email: keren.osman[@]mssm.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Lymphoma
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed Non-Hodgkin's Lymphoma

Intervention

Biological:
• MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
Patients who have minimal residual disease or minimal volume relapse, and are at least four weeks post immunosuppression following allogeneic stem cell transplantation will receive a series of four HDC infusions (100,000 HDC/kg per infusion, one every four weeks(group 1). Those patients who have greater than minimal residual disease will receive HDC infusions, one every four weeks in conjunction with donor lymphocyte infusion (DLI) (group 2).

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.		2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion	Yes
Secondary	The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism		2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion	Yes