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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00057005
• Collaborator: The Methodist Hospital Research Institute (Other), Center for Cell and Gene Therapy, Baylor College of Medicine (Other)
• Enrollment: 6
• Locations: 2
• Arm: 1
• Duration (Months): 80
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
LEUKEMIA	Drug: CAMPATH-1H; Drug: Anti-CD45; Drug: Ara-C; Drug: Cyclophosphamide; Drug: Mesna; Radiation: Total Body Irradiation	Phase 1

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030
2	The Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

• Study Chair: Malcolm K Brenner, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Krance, Professor, Pediatrics-Hem-Onc Cell & Gene, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00057005
• Other Study ID Numbers: H12870; ADVL; NCT00601380
• First Posted: Mar 28, 2003
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Robert Krance, Professor, Pediatrics-Hem-Onc Cell & Gene, Baylor College of Medicine: LEUKEMIA
• Additional relevant MeSH terms: Leukemia; Cyclophosphamide; Alemtuzumab

Study Results

No Results Posted as of Jan 18, 2020