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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683046
First Posted: May 23, 2008
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose

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.

Condition Intervention Phase
Acute Myelogenous Leukemia Lymphoid Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Myeloproliferative Disorder Anemia, Aplastic Myelodysplastic Syndromes Drug: Fludarabine Drug: Melphalan Drug: Stem cells Drug: Campath Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 up to 10 years ]

    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


Secondary Outcome Measures:
  • 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 up to 10 years ]

    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


Enrollment: 204
Study Start Date: November 2001
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Intervention 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683046


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Andrew Artz, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00683046     History of Changes
Other Study ID Numbers: 11300A
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: February 14, 2014
Results First Posted: March 31, 2014
Last Update Posted: November 22, 2016
Last Verified: October 2016

Keywords provided by University of Chicago:
Relapsed or refractory acute myelogenous or lymphoid leukemia.
Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis.
Chronic myelogenous leukemia in chronic phase
Chronic myelogenous leukemia in accelerated phase or blast-crisis
Recurrent or refractory malignant lymphoma or Hodgkin's disease.
Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
Severe aplastic anemia after failure of immunosuppressive therapy.
Myelodysplastic syndromes (including PNH)
Multiple myeloma at high risk for disease recurrence.

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Hodgkin Disease
Myeloproliferative Disorders
Lymphoma
Anemia, Aplastic
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Anemia
Fludarabine
Fludarabine phosphate
Alemtuzumab
Melphalan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites