Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors
N/A
55 Years
Both
Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors
OBJECTIVES:
- Determine a standard approach to hematopoietic stem cell transplantation with matched
unrelated donors in patients with hematologic malignancies.
- Determine the toxicity of this regimen in these patients.
- Determine the relapse rate and survival rate in patients treated with this regimen.
- Correlate incidence and severity of graft-versus-host disease with relapse and survival
in patients treated with this regimen.
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.
PROJECTED ACCRUAL: 50
Inclusion 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.
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
- FEV_1 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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rates of durable engraftment
Outcome Time Frame:
at day 42
Safety Issue:
No
Principal Investigator
Kenneth Cooke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU1Y00
NCT ID:
NCT00054327
Start Date:
November 2000
Completion Date:
September 2011
Related Keywords:
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- adult acute myeloid leukemia in remission
- childhood acute myeloid leukemia in remission
- recurrent adult acute myeloid leukemia
- recurrent childhood acute myeloid leukemia
- adult acute lymphoblastic leukemia in remission
- childhood acute lymphoblastic leukemia in remission
- refractory anemia with excess blasts in transformation
- refractory anemia with excess blasts
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 3 follicular lymphoma
- secondary acute myeloid leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent mantle cell lymphoma
- refractory anemia with ringed sideroblasts
- refractory anemia
- chronic myelomonocytic leukemia
- refractory cytopenia with multilineage dysplasia
- previously treated myelodysplastic syndromes
- de novo myelodysplastic syndromes
- secondary myelodysplastic syndromes
- relapsing chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- juvenile myelomonocytic leukemia
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- childhood myelodysplastic syndromes
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
