Host Dendritic Cells in Allograft Patients - Full Text View

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:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma Multiple Myeloma

U.S. FDA Resources

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).

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

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:

Hodgkin Disease
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on June 17, 2013