Host Dendritic Cells in Allograft Patients

October 28, 2010 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Keren Osman, MD
        • Contact:
          • Keren Osman, MD
          • Phone Number: 212-241-6021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Keren Osman, M.D., Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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