Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00054327
First received: February 5, 2003
Last updated: February 1, 2012
Last verified: February 2012
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Purpose
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Cancer
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Rates of durable engraftment [ Time Frame: at day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Graft-versus-host disease [ Time Frame: measured weekly ] [ Designated as safety issue: No ]
- Incidence of recurrent disease [ Time Frame: at day 100 post transplant ] [ Designated as safety issue: No ]
- Toxicity as measured by CTC v2.0 [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
| Enrollment: | 34 |
| Study Start Date: | November 2000 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV
Radiation: radiation therapy
Patients undergo radiation therapy
|
|
Experimental: Regimen B
Patients receive cyclophosphamide IV and TBI as in regimen A.
|
Drug: cyclophosphamide
Given IV
Radiation: radiation therapy
Patients undergo radiation therapy
|
|
Experimental: 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.
|
Drug: cyclophosphamide
Given IV
Radiation: radiation therapy
Patients undergo radiation therapy
|
|
Experimental: 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.
|
Drug: busulfan
Given orally
Drug: cyclophosphamide
Given IV
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | up to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054327
Locations
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Kenneth Cooke, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00054327 History of Changes |
| Other Study ID Numbers: | CWRU1Y00, P30CA043703, CASE-CWRU-1Y00 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Busulfan Cyclophosphamide Cytarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013