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Host Dendritic Cells in Allograft Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935597
Recruitment Status : Unknown
Verified October 2010 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : October 29, 2010
Sponsor:
Information provided by:
Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsed Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Chronic Lymphocytic Lymphoma Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
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)
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).
Experimental: Group 2
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)
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).


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading. [ Time Frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion ]

Secondary Outcome Measures :
  1. The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism [ Time Frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935597


Contacts
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Contact: Keren Osman, MD (212)241-6021 keren.osman@mssm.edu
Contact: Linda Sacris, RN (212)824-7339 linda.sacris@mssm.edu

Locations
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United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Keren Osman, MD    212-241-6021      
Principal Investigator: Keren Osman, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Keren Osman, M.D. Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Keren Osman, MD, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00935597    
Other Study ID Numbers: 08-0906
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: October 29, 2010
Last Verified: October 2010
Keywords provided by Icahn School of Medicine at Mount Sinai:
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)
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
 Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Chronic Disease
Disease Attributes
Pathologic Processes