We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057005
First Posted: March 28, 2003
Last Update Posted: January 21, 2010
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.
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
  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 Intervention Phase
Leukemia Drug: CAMPATH-1H Drug: Anti-CD45 Drug: Ara-C Drug: Cyclophosphamide Drug: Mesna Radiation: Total Body Irradiation Phase 1

Baylor College of Medicine has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: February 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00057005


Locations
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
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Study Chair: Malcolm K Brenner, MD Baylor College of Medicine
  More Information

Responsible Party: Robert Krance, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00057005     History of Changes
Obsolete Identifiers: NCT00601380
Other Study ID Numbers: H12870
ADVL
First Submitted: March 26, 2003
First Posted: March 28, 2003
Last Update Posted: January 21, 2010
Last Verified: November 2009

Keywords provided by Baylor College of Medicine:
LEUKEMIA

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Alemtuzumab
Antibodies
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists


To Top