Host Dendritic Cells in Allograft Patients

Phase 1

• Conditions: Relapsed Non-Hodgkin's Lymphoma; Hodgkin's Disease; Multiple Myeloma; Chronic Lymphocytic Lymphoma
• Interventions: Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)

• Registration Number: NCT00935597
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Study Start: 2009-08
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-28
• Last Update Posted: 2010-10-29
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)	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
Group 2	MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)	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)

Primary Outcome Measures

Name	Time	Method
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.	2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion

Secondary Outcome Measures

Name	Time	Method
The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism	2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States