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

Sponsor:	Baylor College of Medicine
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

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 I

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:

MedlinePlus related topics: Cancer Leukemia

Drug Information available for: Cyclophosphamide Cytarabine hydrochloride Mesna Campath Alemtuzumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

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:

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.

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

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
Campath 1G
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 February 12, 2012