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Phase I/II Study of CD45 Antibodies and Alemtuzumab Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Hematologic Malignancy

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Trial Information

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.


Inclusion Criteria:



1. Patients with one of the following high risk diseases needing allogeneic hemopoietic
stem cell transplantation:

Acute myeloid leukemia either a) Primary refractory, or b) Beyond first complete
remission(CR1), or c) In CR1 with high risk of relapse

Acute lymphoblastic leukemia either a) Primary refractory, or b) Beyond first
complete remission(CR1), or c) In CR1 with high risk of relapse

Chronic myeloid leukemia, either a) Accelerated phase, or b) Blast crisis, or c)
Chronic phase and not achieving major cytogenetic response despite standard therapy

Chronic lymphocytic leukemia, either a) Primary refractory, or b) Beyond first
complete remission(CR1),

Non Hodgkin's lymphoma, either a) Primary refractory, or b) Beyond first complete
remission(CR1)

Hodgkin's disease, either a) Primary refractory, or b) Beyond first complete
remission(CR1),

Myelodysplastic syndrome with IPSS score > 0. (Appendix A)

Myeloproliferative disorders (with the exclusion of chronic myeloid leukemia) a)
Primary Myelofibrosis with Lile score of 1 or 2 (Appendix B) b) Polycythemia Vera or
Essential Thrombocythemia transformed to AML or Myelofibrosis and PV "spent phase"

Multiple Myeloma with stage II or III disease

Severe aplastic anemia

2. Conditions that increase Treatment Related Mortality (need one or more to be
eligible):

Greater or equal to 35 years of age;

Ejection Fraction of less than 50%;

DLCO less than 50% or FEV1/FVC < 80% of predicted value;

Diabetes Mellitus;

Renal insufficiency (serum creatinine abnormal);

Hepatic dysfunction-transaminases, or alkaline phosphatase, or bilirubin twice the
upper limit of normal;

Prior recent history of systemic fungal infection;

Multiple prior treatment regimens (equal to or more than 3);

Significant Grade III or IV neurologic, cardiac, pulmonary, renal or hepatic toxicity
from previous treatment;

Prior Autologous or Allogeneic Stem Cell transplantation;

3. Available Healthy Donor without any contraindications for donation. 5/6 or 6/6
related or unrelated donor (molecular typing for DRB1);

4. Patient and/or responsible person able to understand and sign consent

Exclusion Criteria:

Pregnant and lactating women, or women unwilling to use contraception.

HIV positive patient

Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

Child's class C cirrhosis

Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months)

Patients with known allergy to rat serum products

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

100 days post transplant

Safety Issue:

Yes

Principal Investigator

Malcolm K Brenner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

12472

NCT ID:

NCT00056966

Start Date:

November 2002

Completion Date:

December 2006

Related Keywords:

  • Hematologic Malignancy
  • Acute myeloid leukemia
  • Acute lymphoblastic leukemia
  • Chronic myeloid leukemia
  • Non-Hodgkin's lymphoma
  • Hodgkin's disease
  • Myelodysplastic syndrome
  • Myeloproliferative disorders
  • Multiple myeloma
  • Severe aplastic anemia
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms

Name

Location

Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030