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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


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion

Safety Issue:

Yes

Principal Investigator

Keren Osman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

08-0906

NCT ID:

NCT00935597

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Relapsed Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Chronic Lymphocytic Lymphoma
  • 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)
  • Hodgkin Disease
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mount Sinai Medical Center New York, New York  10029