Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054327

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 Procedure: radiation therapy	Phase II

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Engraftment as measured by bone marrow biopsy days 28-35 after transplant [ Designated as safety issue: No ]
Toxicity as measured by CTC v2.0 weekly [ Designated as safety issue: Yes ]
Relapse rate measured at day 90 after transplantation, and then 1 and 2 years [ Designated as safety issue: No ]
Survival as measured at day 90 after transplantation, and then 1 and 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Graft-versus-host disease measured weekly [ Designated as safety issue: No ]

Study Start Date:	November 2000
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Regimen A: Experimental 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 Procedure: radiation therapy Patients undergo radiation therapy
Regimen B: Experimental Patients receive cyclophosphamide IV and TBI as in regimen A.	Drug: cyclophosphamide Given IV Procedure: radiation therapy Patients undergo radiation therapy
Regimen B2: Experimental 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 Procedure: radiation therapy Patients undergo radiation therapy
Regimen C: Experimental 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: Not specified

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 Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
Geauga Regional Hospital	Recruiting
Cleveland, Ohio, United States, 44024
Contact: Susan Wiersma 440-285-6000
Lake/University Ireland Cancer Center	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Susan Wiersma 440-205-5755
Mercy Cancer Center at Mercy Medical Center	Recruiting
Cleveland, Ohio, United States, 44708
Contact: Susan Wiersma 330-430-2788
University Suburban Health Center	Recruiting
Cleveland, Ohio, United States, 44121
Contact: Susan Wiersma 216-844-3871
UHHS Chagrin Highlands Medical Center	Recruiting
Cleveland, Ohio, United States, 44122
Contact: Susan Wiersma 216-292-1783
UHHS Westlake Medical Center	Recruiting
Cleveland, Ohio, United States, 44145
Contact: Susan Wiersma 440-250-2001
Southwest General Health Center	Recruiting
Cleveland, Ohio, United States, 44130
Contact: Susan Wiersma 440-816-8000

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Susan Wiersma, MD

Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000270380, CASE-CWRU-1Y00, CASE-1Y00
Study First Received:	February 5, 2003
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00054327
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Juvenile myelomonocytic leukemia
Blast Crisis
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Refractory anemia
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Acute myeloid leukemia, adult
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Myeloproliferative Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Hematologic Neoplasms
Precancerous Conditions
Lymphoma, Follicular

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009