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Completed

NCT Number: NCT00683046

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.

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Key information

Conditions

Acute Myelogenous Leukemia Anemia Anemia, Aplastic Blast Crisis Bone Marrow Diseases Bone Marrow Failure Disorders Bone Marrow Neoplasms Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoid Leukemia Lymphoma Lymphoproliferative Disorders Malignant Lymphoma Myelodysplastic Syndromes Myeloproliferative Disorder Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Primary Myelofibrosis Recurrence

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.

melphalan

Drug

Melphalan 140 mg/m2 IV on day -2.

stem cells

Drug

Stem cell infusion on day 0.

Campath

Drug

Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Primary outcomes

  1. 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;

    • Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
    • Melphalan 140mg/m2 IV on day -2
    • Stem cell infusion on day 0
    • Campath 20mg IV on day -7,-6,-5,-4, and -3

Secondary outcomes

  1. 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;

    • Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
    • Melphalan 140mg/m2 IV on day -2
    • Stem cell infusion on day 0
    • Campath 20mg IV on day -7,-6,-5,-4, and -3

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2001
Primary completion
2014
Study completion
2014
First posted
May 23, 2008
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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