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Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation - Article


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Cardiolipin Antibodies


Clinical Trial: Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation

This study is currently recruiting patients.

Sponsors and Collaborators: Baylor College of Medicine
The Methodist Hospital
Texas Children's Hospital
Information provided by: Baylor College of Medicine

Purpose

Participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. Participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The participants donor is a family member. Stem cells are cells in the bone marrow and blood that can form a whole new blood system.

Condition Treatment or Intervention Phase
Leukemia
 Drug: CAMPATH-1H
 Drug: Anti-CD45
 Drug: Cytarabine
 Drug: Cyclophosphamide
 Drug: Mesna
 Procedure: Total Body Irradiation
 Drug: FK506
Phase I

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)

Further Study Details: 

Expected Total Enrollment:  24

Study start: February 2003

Patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. To try and improve on the results of transplants that use high dose chemotherapy alone, we are adding an agent called anti-CD45 to the treatment prior to the stem cell transplant. Anti-CD45 is an antibody that specifically finds and destroys leukemia cells.

Patients will receive the anti-CD45 with high dose chemotherapy (including Ara-C and Cyclophosphamide) and radiotherapy. Patients will also receive Mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. High dose radiotherapy is also known as Total Body Irradiation or TBI.

Patients will receive the anti-CD45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. We expect participation in this study will last 2 years.

A summary of the treatment follows:

  • Day - 7: Ara-C, Cyclophosphamide, Mesna
  • Day - 6: Ara-C, Cyclophosphamide, Mesna
  • Day - 5: Ara-C, Anti-CD45
  • Day - 4: Anti-CD45, TBI
  • Day - 3: Anti-CD45, TBI
  • Day - 2: Anti-CD45, TBI
  • Day - 1: TBI
  • Day 0: Stem Cell Infusion (transplant)

Eligibility

Ages Eligible for Study:  up to  45 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • Patients with advanced leukemia or other hematologic malignancy including AML, ALL, CML, and MDS. Advanced features include: a) Induction failure, prolonged induction beyond 6 weeks b) Incomplete response to salvage therapy c) CML in blast crisis or acute leukemia in chemotherapy resistant relapse d) secondary leukemia or secondary myelodysplastic disease
  • Patients with CD45 present on leukemic blasts at a level of >/= 95% as documented by flow cytometry
  • Patients must have a suitable HLA identical sibling donor or 5/6 matched related donor, or fully matched or 5/6 matched unrelated donor

Exclusion criteria:

  • Patients with a life expectancy (</= 6 weeks) limited by diseases other than leukemia
  • Patients with T-cell lymphoblastic lymphoma
  • Patients with symptomatic cardiac disease or evidence of significant cardiac disease by echocardiogram
  • Patients with liver disease that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
  • Patients with severe renal disease (Creatinine > 2x normal for age)
  • Patients with known allergy to rat serum products
  • Patients with a Lansky score <60% or Karnofsky score <60%
  • Patients with severe infection that on evaluation by the PI precludes ablative radio/chemotherapy or successful transplantation
  • Patients with severe personality disorder or mental illness
  • Patients with documented HIV positivity
  • Pregnant or lactating females

Location and Contact Information


Texas
      The Methodist Hospital, Houston,  Texas,  77030,  United States; Recruiting
Robert K Krance, MD  832-824-4661    rkkrance@bcm.tmc.edu 

      Texas Children's Hospital, Houston,  Texas,  77030,  United States; Recruiting
Robert K Krance, MD  832-824-4661    rkkrance@bcm.tmc.edu 

Study chairs or principal investigators

Malcolm K Brenner, MD,  Study Chair,  Baylor College of Medicine   

More Information

Study ID Numbers:  H12870; ADVL
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 26, 2003
ClinicalTrials.gov Identifier:  NCT00057005
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: June 1, 2005
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