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

This study has been completed.
Sponsor:
Collaborators:
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00057005
First received: March 26, 2003
Last updated: January 19, 2010
Last verified: November 2009
  Purpose

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

Baylor College of Medicine has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 28 days and 100 days post transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)
  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057005

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Texas Children's Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Study Chair: Malcolm K Brenner, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Robert Krance, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00057005     History of Changes
Obsolete Identifiers: NCT00601380
Other Study ID Numbers: H12870, ADVL
Study First Received: March 26, 2003
Last Updated: January 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
LEUKEMIA

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Antibodies, Monoclonal
Cyclophosphamide
Alemtuzumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 21, 2014