LEUKEMIA
Conditions
Keywords
LEUKEMIA
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.
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)
Interventions
DRUGCAMPATH-1H
Day-8 through Day-6 according to institutional SOPs
DRUGAnti-CD45
Day-5 400 μg/kg
DRUGAra-C
day-7 through day-5 3000 mg/m2 q 12h
DRUGCyclophosphamide
Day-7 through Day-6 45 mg/kg
DRUGMesna
Days -7 and -6 45 mg/kg divided into 5 doses
RADIATIONTotal Body Irradiation
150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)
Sponsors
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 28 days and 100 days post transplant |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 100 days post transplant |
Countries
United States
Outcome results
None listed