Recruiting
Phase 1

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT00935597

Conditions

Relapsed Non-Hodgkin's Lymphoma

Hodgkin's Disease

Multiple Myeloma

Chronic Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT00935597

Start date

Aug, 2009

Status verified date

Oct, 2010

Primary completion date

Jul, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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)

Interventions

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).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Keren Osman, MD

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

Linda Sacris, RN

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

Locations

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

Keren Osman, MD

212-241-6021

Principal Investigator:

Keren Osman, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 29, 2010

Last verified

Oct, 2010

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2010-10-29.