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

NCT00057005 | Completed Phase 1 DMC

• 2 other identifiers: H12870ADVL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

LEUKEMIA

Keywords

LEUKEMIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: CAMPATH-1H; Drug: Anti-CD45; Drug: Ara-C; Drug: Cyclophosphamide; Drug: Mesna; Radiation: Total Body Irradiation

Interventions

CAMPATH-1H DRUG

Day-8 through Day-6 according to institutional SOPs

1

Anti-CD45 DRUG

Day-5 400 μg/kg

1

Ara-C DRUG

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

1

Cyclophosphamide DRUG

Day-7 through Day-6 45 mg/kg

1

Mesna DRUG

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

1

Total Body Irradiation RADIATION

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

1

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Alemtuzumab; Cytarabine; Cyclophosphamide; Mesna; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Malcolm K Brenner, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics-Hem-Onc Cell & Gene

Study Record Dates

• First Submitted: March 26, 2003
• First Posted: March 28, 2003
• Study Start: February 1, 2003
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (2)