Host Dendritic Cells in Allograft Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00935597
First received: July 7, 2009
Last updated: October 28, 2010
Last verified: October 2010
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: August 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935597

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

Locations
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
Mount Sinai School of Medicine
Investigators
Principal Investigator: Keren Osman, M.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Keren Osman, MD, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00935597     History of Changes
Other Study ID Numbers: 08-0906
Study First Received: July 7, 2009
Last Updated: October 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
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:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia

ClinicalTrials.gov processed this record on September 22, 2014