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Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)

This study has been completed.
Sponsor:
Collaborators:
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00057005
First received: March 26, 2003
Last updated: January 19, 2010
Last verified: November 2009

March 26, 2003
January 19, 2010
February 2003
October 2009   (final data collection date for primary outcome measure)
To evaluate the toxicity and the anti-tumor activity of anti-human CD45 antibodies (anti-CD45) administered to patients with relapsed/resistant leukemia prior to bone marrow transplantation. [ Time Frame: 28 days and 100 days post transplant ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00057005 on ClinicalTrials.gov Archive Site
To describe the effects of anti-CD45 on normal hematopoiesis and on complement levels and to describe the effects of anti-CD45 on leukemic blast cells. [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)

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.

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)
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: CAMPATH-1H
    Day-8 through Day-6 according to institutional SOPs
  • Drug: Anti-CD45
    Day-5 400 μg/kg
  • Drug: Ara-C
    day-7 through day-5 3000 mg/m2 q 12h
  • Drug: Cyclophosphamide
    Day-7 through Day-6 45 mg/kg
  • Drug: Mesna
    Days -7 and -6 45 mg/kg divided into 5 doses
  • Radiation: Total Body Irradiation
    150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)
Experimental: 1
Interventions:
  • Drug: CAMPATH-1H
  • Drug: Anti-CD45
  • Drug: Ara-C
  • Drug: Cyclophosphamide
  • Drug: Mesna
  • Radiation: Total Body Irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. Patients must have a suitable HLA identical sibling donor or 5/6 matched related donor, or fully matched or 5/6 matched unrelated donor, or haploidentical related donor.

Exclusion Criteria:

1. Patients with a life expectancy (2X normal for age) 7. Patients with known allergy to rat serum products 8. Patients with a Lansky score <60% or Karnofsky score <60%. 9. Patients with severe infection that on evaluation by the PI precludes ablative radio/chemotherapy or successful transplantation. 10. Patients with sever personality disorder or mental illness. 11. Patients with documented HIV positivity 12. Pregnant or lactating females

Both
up to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057005
H12870, ADVL
Yes
Robert Krance, MD, Baylor College of Medicine
Baylor College of Medicine
  • The Methodist Hospital System
  • Texas Children's Hospital
  • Center for Cell and Gene Therapy, Baylor College of Medicine
Study Chair: Malcolm K Brenner, MD Baylor College of Medicine
Baylor College of Medicine
November 2009

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