T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
First received: May 21, 2008
Last updated: February 14, 2014
Last verified: February 2014

May 21, 2008
February 14, 2014
November 2001
December 2013   (final data collection date for primary outcome measure)
Median Disease-free Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies
Disease-free survival [ Time Frame: annually ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00683046 on ClinicalTrials.gov Archive Site
Median Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies
Not Provided
Not Provided
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T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Objectives:

  1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
  2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
  3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Lymphoid Leukemia
  • Chronic Myelogenous Leukemia
  • Malignant Lymphoma
  • Hodgkin's Disease
  • Chronic Lymphocytic Leukemia
  • Myeloproliferative Disorder
  • Anemia, Aplastic
  • Myelodysplastic Syndromes
  • Drug: Fludarabine
    Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
  • Drug: Melphalan
    Melphalan 140 mg/m2 IV on day -2.
  • Drug: Stem cells
    Stem cell infusion on day 0.
  • Drug: Campath
    Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
204
December 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Zubrod performance status 2 (See Appendix B).
  • Life expectancy is not severely limited by concomitant illness.
  • Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
  • Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
  • Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal
  • No evidence of chronic active hepatitis or cirrhosis.
  • HIV-negative
  • Patient is not pregnant
  • Patient or guardian able to sign informed consent.

Exclusion Criteria:

  • N/A
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00683046
11300A
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Andrew Artz, MD University of Chicago
University of Chicago
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP