Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Anti-CD45 Monoclonal Antibody, Cytarabine, Cyclophosphamide, and Total-Body Irradiation With or Without Alemtuzumab in Treating Patients Undergoing a Donor Stem Cell Transplant For Advanced Leukemia or Other Hematologic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	45 and under	Other	BCM-H-12870 H 12870, BCM-ADVL, NCT00601380

Objectives

Primary

1. To evaluate the toxicity and the anti-tumor activity of anti-CD45 monoclonal antibody in patients with relapsed or resistant leukemia or other hematologic malignancy undergoing allogeneic stem cell transplantation.

Secondary

1. To describe the effects of anti-CD45 on normal hematopoiesis and on complement levels.
2. To describe the effects of anti-CD45 on leukemic blast cells.

Entry Criteria

Disease Characteristics:

• Confirmed diagnosis of advanced leukemia or other hematologic malignancy, including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia (CML), or myelodysplastic disease
  • • Advanced features include any of the following:
      • Induction failure, prolonged induction beyond 6 weeks
      • Incomplete response to salvage therapy
      • CML in blast crisis or acute leukemia in chemotherapy resistant relapse
      • Secondary leukemia or secondary myelodysplastic disease



• CD45 present on leukemic blasts at a level of > 95% as documented by flow cytometry



• HLA identical sibling donor or 5/6 matched related donor OR fully matched or 5/6 matched unrelated donor available



• No T-cell lymphoblastic lymphoma

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• Lansky performance status (PS) 70-100%% or Karnofsky PS 70-100%
• Life expectancy > 6 weeks (not limited by diseases other than leukemia)
• No symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
• No liver disease that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
• Creatinine ≤ 2 times upper limit of normal
• No known allergy to rat serum products
• No severe infection that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
• No severe personality disorder or mental illness
• No documented HIV positivity
• Not pregnant or lactating

Expected Enrollment

Outcomes

Toxicity by NCI CTCAE criteria

Effects of anti-CD45 on normal hematopoiesis and on complement levels
Effects of anti-CD45 on leukemic blast cells

Outline

• Preparative regimen: Patients receive treatment based on their relationship to the stem cell donor (related or unrelated).
  • HLA-identical or 5/6 matched related donors: Patients receive anti-CD45 monoclonal antibody IV on days -5 to -2, cytarabine IV twice daily on days -7 to -5, cyclophosphamide IV on days -7 and -6. Patients also undergo total body irradiation twice daily on days -4 to -1.
  • HLA-identical or 5/6 matched unrelated donors: Patients receive anti-CD45 monoclonal antibody, cytarabine, and cyclophosphamide and undergo total-body irradiation therapy as above. Patients also receive alemtuzumab IV on days -8 to -6.



• Allogeneic stem cell transplantation: All patients undergo peripheral blood or bone marrow stem cell infusion on day 0.



• Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV beginning on day -2 and continuing as per the treating physician.

Trial Contact Information

Trial Lead Organizations

Dan L. Duncan Cancer Center at Baylor College of Medicine

Robert Krance, MD, Protocol chair		Ph: 832-824-4599 Email: rkrance@bcm.tmc.edu

U.S.A.
Texas
	Houston
	Methodist Hospital
		Marlen Dinu	Ph:  832-824-4881
	Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
		Marlen Dinu	Ph:  832-824-4881

Registry Information
Official Title		PHASE I/II STUDY OF ANTI-HUMAN CD45 MONOCLONAL ANTIBODIES IN PATIENTS WITH ADVANCED LEUKEMIA PRIOR TO ALLOGENEIC STEM CELL TRANSPLANTATION
Trial Start Date		2003-02-05
Trial Completion Date		2011-04-05 (estimated)
Registered in ClinicalTrials.gov		NCT00601380
Date Submitted to PDQ		2007-12-13
Information Last Verified		2008-11-30