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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
First received: May 21, 2008
Last updated: October 5, 2015
Last verified: October 2015

May 21, 2008
October 5, 2015
November 2001
December 2014   (final data collection date for primary outcome measure)
Median Disease-free Survival [ Time Frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter ] [ Designated as safety issue: No ]

All patients were administered the following drugs;

  1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
  2. Melphalan 140mg/m2 IV on day -2
  3. Stem cell infusion on day 0
  4. Campath 20mg IV on day -7,-6,-5,-4, and -3
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: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter ] [ Designated as safety issue: No ]

All patients were administered the following drugs;

  1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
  2. Melphalan 140mg/m2 IV on day -2
  3. Stem cell infusion on day 0
  4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Not Provided
Not Provided
Not Provided
 
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.
Experimental: Drug Intervention
Interventions:
  • Drug: Fludarabine
  • Drug: Melphalan
  • Drug: Stem cells
  • Drug: Campath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
December 2014
December 2014   (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:

Both
up to 100 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00683046
11300A
Yes
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Andrew Artz, MD University of Chicago
University of Chicago
October 2015

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