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

LEUKEMIA Clinical Trial

— ADVL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057005
• Other study ID #: H12870
• Secondary ID: ADVL
• Status: Completed
• Phase: Phase 1
• Start date: February 2003
• Est. completion date: October 2009

Study information

• Verified date: January 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Other known NCT identifiers

• NCT00601380

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• LEUKEMIA

Intervention

Drug:
• CAMPATH-1H
Day-8 through Day-6 according to institutional SOPs
• Anti-CD45
Day-5 400 µg/kg
• Ara-C
day-7 through day-5 3000 mg/m2 q 12h
• Cyclophosphamide
Day-7 through Day-6 45 mg/kg
• 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)

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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