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

Alternate Title

Cytarabine, Cyclophosphamide, Alemtuzumab, and Total Body Irradiation Followed By a Donor Stem Cell Transplant and Donor T-cell Infusions in Treating Patients With Leukemia or Other Hematologic Disorders

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active Any age Other BCM-H-9033 H-9033, NCT00586547

Objectives

1. To determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of grade III/IV graft-versus-host disease ≤ 25%.
2. To analyze immune reconstitution in these patients.
3. To measure their overall and disease-free survival at 100 days and at 1 year.

Entry Criteria

Disease Characteristics:

• Confirmed diagnosis of one of the following:
  • Acute lymphoblastic leukemia meeting the following criteria:
    • Stage III or IV disease
    • Relapsed disease or primary refractory disease
  • Stage III or IV high-grade non-Hodgkin lymphoma meeting 1 of the following criteria:
    • Relapsed disease
    • Primary refractory disease
  • Myelodysplastic syndromes
  • Acute myeloid leukemia after first relapse or with primary refractory disease
  • Chronic myelogenous leukemia hemophagocytic lymphohistiocytosis
  • Familial hemophagocytic lymphohistiocytosis
  • Viral-associated hemophagocytic syndrome
  • X-linked lymphoproliferative disease with severe, chronic, active Epstein-Barr virus infection with predilection for T- or NK-cell malignancy



• Lack of suitable conventional donor (i.e., 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor

 [Note: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• Life expectancy > 6 months (not limited by disease other than leukemia)
• No symptomatic cardiac disease or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
• Creatinine clearance ≥ 40 mL/min
• No pre-existing severe restrictive pulmonary disease
• FVC ≥ 40% of predicted
• Direct bilirubin ≤ 3 μg/dL
• AST ≤ 500 μg/dL
• No severe personality disorder or mental illness that would preclude compliance with the study
• No severe infection that would precluded ablative chemotherapy or successful transplantation
• No HIV positivity

Expected Enrollment

Outcomes

Number of donor lymphocytes given to patients

Immune reconstitution
Overall survival at 100 days and 1 year
Disease-free survival at 100 days and 1 year

Outline

• Preparative regimen: Patients receive cytarabine IV every 12 hours on days -8 to -5, cyclophosphamide IV on days -7 to -6, and alemtuzumab IV on days -3 to -1. Patients also undergo total body irradiation twice daily on days -4 to -1.



• Stem cell infusion: Patients undergo allogeneic stem cell transplantation.



• Allogeneic T-cell infusion: Patients undergo allogeneic T- cell transplantation.

Trial Contact Information

Trial Lead Organizations

Dan L. Duncan Cancer Center at Baylor College of Medicine

Malcolm Brenner, MD, PhD, Protocol chair		Ph: 832-824-4671 Email: mbrenner@bcm.tmc.edu

U.S.A.
Texas
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor College of Medicine	Ph:  713-798-1297
	Methodist Hospital
		Yu-Feng Lin	Ph:  832-824-4258
	Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
		Yu-Feng Lin	Ph:  832-824-4258

Registry Information
Official Title		A PHASE I TRIAL EVALUATING THE USE OF RFT5-DGA TO DEPLETE ALLOREACTIVE CELLS PRIOR TO HAPLOIDENTICAL STEM CELL TRANSPLANTATION
Trial Start Date		2000-07-25
Trial Completion Date		2028-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00586547
Date Submitted to PDQ		2007-12-14
Information Last Verified		2008-04-13