Host Dendritic Cells in Allograft Patients

NCT00935597 | Unknown Phase 1 DMC

• 1 other identifier: 08-0906
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Patients with Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion

Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)

Group 2

EXPERIMENTAL

Patients with greater than Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion in conjunction with donor lymphocyte infusion (DLI)

Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)

Interventions

MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) BIOLOGICAL

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).

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma; Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoma, B-Cell

Study Officials

• Keren Osman, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keren Osman, MD

CONTACT

(212)241-6021; keren.osman@mssm.edu

Linda Sacris, RN

CONTACT

(212)824-7339; linda.sacris@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2013
• Last Updated: October 29, 2010

Record last verified: 2010-10

Locations

US (1)