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In-Vivo Activated T-Cell Depletion to Prevent GVHD


N/A
18 Years
75 Years
Not Enrolling
Both
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Lymphoma, Non-Hodgkin's, Mantle-Cell Lymphoma, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis

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Trial Information

In-Vivo Activated T-Cell Depletion to Prevent GVHD


Inclusion Criteria:



- Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia,
Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell,
Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility
requirements as outlined in the protocol

- Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated
donor, eighteen years of age or older, who is capable of undergoing GCSF
mobilization and apheresis.

Exclusion Criteria:

- Active CNS disease (the presence of leukemic blasts in the CSF)

- Pregnancy or breast-feeding

- SGOT >3x upper limit of normal

- Creatinine >2 or creatinine clearance <50cc/hr.

- Fractional shortening by echocardiogram not within normal limits per institution

- Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia

- Prior allogeneic transplant

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients With Acute Grade II-IV GVHD

Outcome Description:

Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Outcome Time Frame:

until 30 days after stem cell transplant

Safety Issue:

Yes

Principal Investigator

Robert Nelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana Universtiy School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

0705-20 IUCRO-0196

NCT ID:

NCT00594308

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Lymphoma, Non-Hodgkin's
  • Mantle-Cell Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Myelofibrosis
  • Primary Myelofibrosis
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Mantle-Cell

Name

Location

Indiana Universtiy Simon Cancer CenterIndianapolis, Indiana  46202