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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057005
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : January 18, 2020
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Robert Krance, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
LEUKEMIA Drug: CAMPATH-1H Drug: Anti-CD45 Drug: Ara-C Drug: Cyclophosphamide Drug: Mesna Radiation: Total Body Irradiation Phase 1

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)
Study Start Date : February 2003
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: 1 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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057005

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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
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Study Chair: Malcolm K Brenner, MD Baylor College of Medicine
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Responsible Party: Robert Krance, Professor, Pediatrics-Hem-Onc Cell & Gene, Baylor College of Medicine Identifier: NCT00057005    
Obsolete Identifiers: NCT00601380
Other Study ID Numbers: H12870
First Posted: March 28, 2003    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Robert Krance, Baylor College of Medicine:
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological