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Host Dendritic Cells in Allograft Patients

Primary Purpose

Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Non-Hodgkin's Lymphoma focused on measuring 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)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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)

Outcomes

Primary Outcome Measures

The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.

Secondary Outcome Measures

The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism

Full Information

First Posted
July 7, 2009
Last Updated
October 28, 2010
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT00935597
Brief Title
Host Dendritic Cells in Allograft Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
Intervention Description
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 Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keren Osman, MD
Phone
(212)241-6021
Email
keren.osman@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Sacris, RN
Phone
(212)824-7339
Email
linda.sacris@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keren Osman, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keren Osman, MD
Phone
212-241-6021
First Name & Middle Initial & Last Name & Degree
Keren Osman, MD

12. IPD Sharing Statement

Learn more about this trial

Host Dendritic Cells in Allograft Patients

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