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

Alternate Title

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	55 and under	NCI	CASE-CWRU-1Y00 NCT00054327, CASE-1Y00

Objectives

1. Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies.
2. Determine the toxicity of this regimen in these patients.
3. Determine the relapse rate and survival rate in patients treated with this regimen.
4. Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• One of the following histologically confirmed diseases:
  • Acute myeloid leukemia (AML)
    • In first, second, or greater remission
    • In early relapse (less than 30% marrow blasts)
  • Acute lymphoblastic leukemia (ALL)
    • In second or greater complete remission
    • High-risk ALL in first complete remission, defined by 1 of the following factors:
      • t(4;11), t(9;22), or t(8;14) translocation
      • Extreme hyperleukocytosis (WBC greater than 500,000/mL) at presentation
      • Failure to achieve a complete remission after standard induction therapy
  • Chronic myelogenous leukemia
  • Myelodysplastic syndromes
    • Evolution to AML included
      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
  • Intermediate or high-grade lymphoma
    • Complete response (CR) or partial response (PR) after first or greater relapse

      OR

    • PR only after first-line therapy

 [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:

Biologic therapy

• At least 1 year since prior stem cell transplantation

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 55 and under

Performance status

• ECOG 0-2

  OR

• Lansky 80-100%

Life expectancy

• At least 3 months

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin less than 2.5 mg/dL
• AST less than 4 times upper limit of normal
• No chronic active hepatitis

Renal

• Creatinine no greater than 2.0 mg/dL
• Creatinine clearance at least 50 mL/min by 24-hour urine collection

Cardiovascular

• Resting ejection fraction at least 50%
• Shortening fraction greater than 28% (for small children)
• No angina requiring treatment
• No congestive heart failure requiring treatment
• No myocardial infarction within the past year

Pulmonary

• FEV₁ at least 50% of predicted
• Arterial partial pressure of oxygen at least 80 mm Hg by pulmonary function testing
• Diffusion capacity at least 50% of predicted

Other

• Not pregnant or nursing
• Negative pregnancy test
• HIV negative
• No uncontrolled diabetes mellitus
• No active infection, including any of the following:
  • Soft tissue infection
  • Sinus infection
  • Dental infection
  • Fungal infection
• No significant psychiatric illness that would preclude study participation
• No medical complication that makes the risk of death during transplantation from nonmalignant causes greater than the risk of relapse

Expected Enrollment

Not specified

Outcomes

Engraftment as measured by bone marrow biopsy days 28-35 after transplant
Toxicity as measured by CTC v2.0 weekly
Relapse rate measured at day 90 after transplantation, and then 1 and 2 years
Survival as measured at day 90 after transplantation, and then 1 and 2 years

Graft-versus-host disease measured weekly

Outline

Patients receive 1 of the following preparative regimens:

• Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1.



• Regimen B: Patients receive cyclophosphamide IV and TBI as in regimen A.



• Regimen B2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1.



• Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2.

All patients undergo stem cell transplantation from a matched, unrelated donor on day 0.

Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Susan Wiersma, MD, Protocol chair		Ph: 216-844-3345 Email: srw3@po.cwru.edu

U.S.A.
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Geauga Regional Hospital
		Susan Wiersma	Ph:  440-285-6000
	Lake/University Ireland Cancer Center
		Susan Wiersma	Ph:  440-205-5755
	Mercy Cancer Center at Mercy Medical Center
		Susan Wiersma	Ph:  330-430-2788 888-293-4673
	Southwest General Health Center
		Susan Wiersma	Ph:  440-816-8000
	UHHS Chagrin Highlands Medical Center
		Susan Wiersma	Ph:  216-292-1783
	UHHS Westlake Medical Center
		Susan Wiersma	Ph:  440-250-2001
	University Suburban Health Center
		Susan Wiersma	Ph:  216-844-3871

Registry Information
Official Title		Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors
Trial Start Date		2000-11-10
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00054327
Date Submitted to PDQ		2002-12-31
Information Last Verified		2009-05-28
NCI Grant/Contract Number		CA43703

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