Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
25 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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).
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)
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).
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Mount Sinai School of Medicine
Principal Investigators
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Keren Osman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Keren Osman, MD
Role: primary
Other Identifiers
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08-0906
Identifier Type: -
Identifier Source: org_study_id