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

NCT ID: NCT00057005

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-10-31

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)

Conditions

LEUKEMIA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

CAMPATH-1H

Intervention Type: DRUG

Day-8 through Day-6 according to institutional SOPs

Anti-CD45

Intervention Type: DRUG

Day-5 400 μg/kg

Ara-C

Intervention Type: DRUG

day-7 through day-5 3000 mg/m2 q 12h

Cyclophosphamide

Intervention Type: DRUG

Day-7 through Day-6 45 mg/kg

Mesna

Intervention Type: DRUG

Days -7 and -6 45 mg/kg divided into 5 doses

Total Body Irradiation

Intervention Type: RADIATION

150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)

Interventions

CAMPATH-1H

Day-8 through Day-6 according to institutional SOPs

Intervention Type: DRUG

Anti-CD45

Day-5 400 μg/kg

Intervention Type: DRUG

Ara-C

day-7 through day-5 3000 mg/m2 q 12h

Intervention Type: DRUG

Cyclophosphamide

Day-7 through Day-6 45 mg/kg

Intervention Type: DRUG

Mesna

Days -7 and -6 45 mg/kg divided into 5 doses

Intervention Type: DRUG

Total Body Irradiation

150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)

Intervention Type: RADIATION

Eligibility Criteria

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

• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Robert Krance

Professor, Pediatrics-Hem-Onc Cell & Gene

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malcolm K Brenner, MD

Role: STUDY_CHAIR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

ADVL

Identifier Type: -

Identifier Source: secondary_id

H12870

Identifier Type: -

Identifier Source: org_study_id

NCT00601380

Identifier Type: -

Identifier Source: nct_alias