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Home > "A" Clinical Trials Conditions > Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation  Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
For Condition: Leukemia
Status: Recruiting
Sponsor(s): Baylor College of Medicine , The Methodist Hospital,Texas Children's Hospital
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /45 Years
Genders: Both
Protocol Entry 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 ( 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
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Study Chair, Baylor College of Medicine
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Robert Krance 832-824-4661
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Robert Krance 832-824-4661
Additional Information:
Study ID Numbers: H12870; ADVL
Study Start Date: February 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057005
Other Leukemia Studies:
1. Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis
2. Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
3. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
5. Evaluating a New Transplant Regimen for High-Risk Leukemia Patients with Partially Matched Related Donors
Related Studies:
Other Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
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