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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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: 10 years ] [ Designated as safety issue: No ]
    T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies


Secondary Outcome Measures:
  • 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


Enrollment: 204
Study Start Date: November 2001
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00683046     History of Changes
Other Study ID Numbers: 11300A
Study First Received: May 21, 2008
Results First Received: February 14, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

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:
Anemia
Anemia, Aplastic
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Hematologic Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Precancerous Conditions
Neoplasms by Site
Melphalan
Fludarabine
Fludarabine monophosphate
Alemtuzumab
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 22, 2014