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

Phase 1
45 Years
Not Enrolling

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Trial Information

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

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

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)

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

28 days and 100 days post transplant

Safety Issue:


Principal Investigator

Malcolm K Brenner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

October 2009

Related Keywords:

  • Leukemia
  • Leukemia



Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030