Phase I/II Study of CD45 Antibodies and Alemtuzumab Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases
CAMPATH-1H will be given as a daily IV infusion for three days. Fludarabine will be given as
a daily IV infusion for four days. Anti-CD45 will be given as a daily IV infusion for 4
days. Patients will then receive radiotherapy (also known as Total Body Irradiation or TBI)
for one day. A summary of the treatment follows:
- Day - 8: CAMPATH-1H and Fludarabine
- Day - 7: CAMPATH-1H and Fludarabine
- Day - 6: CAMPATH-1H and Fludarabine
- Day - 5: Anti-CD45 and Fludarabine
- Day - 4: Anti-CD45
- Day - 3: Anti-CD45
- Day - 2: Anti-CD45
- Day - 1: TBI
- Day 0: Stem Cell Infusion (transplant)
To help prevent the body from developing GVHD, patients will also receive the drug FK506,
starting two days before the transplant and continuing for at least one month.
Both the CAMPATH-1H and the Anti-CD45 can cause allergic reactions so patients will be given
drugs to help prevent those reactions before receiving daily doses.
To see how CAMPATH-1H works in patients with hematologic malignancies, some patients will be
asked to participate in pharmacokinetic studies. For this, approximately 13 blood samples
will be taken from the central line scheduled before each infusion on Day -8 to Day -6,
daily thereafter until Day 0, and then approximately once per week on days 7, 14, 21 and 28
post transplant. No more than 5 teaspoonfuls total will be drawn.
To see how Anti-CD45 works in patients with hematologic malignancies some patients will be
asked to participate in pharmacokinetic studies. Approximately 22 blood samples will be
taken from the central line scheduled before, during and after each infusion and after the
end of the last infusion of Anti-CD45. No more than 10 teaspoonfuls total will be drawn over
the course of the four anti-CD45 infusions.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess safety and feasibility of monoclonal abs directed to CD45 and CD52 antigens, Fludarabine and low dose TBI, as a non-myeloablative preparatory regimen for allo HSCT. This will be determined by 100d Non-relapse mortality and 100d Graft rejection
100 days post transplant
Yes
Malcolm K Brenner, MD
Study Chair
Baylor College of Medicine
United States: Food and Drug Administration
12472
NCT00056966
November 2002
December 2006
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |
The Methodist Hospital | Houston, Texas 77030 |