Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
This study is currently recruiting patients.
Sponsored by: |
H. Lee Moffitt Cancer Center and Research Institute
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation
therapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of donor bone marrow transplantation in treating patients who have hematologic
cancers.
Condition
|
Treatment or Intervention |
Phase |
acute leukemia atypical chronic myeloid leukemia chronic leukemia chronic myeloproliferative disorders myelodysplastic and myeloproliferative disease plasma cell neoplasm
|
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: etoposide Drug: methotrexate Procedure: allogeneic bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: graft versus host disease prophylaxis/therapy Procedure: radiation therapy Procedure: supportive care/therapy
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Phase II
|
MedlinePlus related topics: Bone Marrow Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Allogeneic Bone Marrow Transplantation in Patients With Hematologic Malignancies
Further Study Details:
OBJECTIVES:
- Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older
allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation
(BMT).
- Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body
irradiation, and allogeneic BMT.
- Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease
prophylaxis in these patients.
- Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.
OUTLINE:
- Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic
disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior
radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT).
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic
bone marrow is infused on day 0.
- Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia
with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide
followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and
etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days
during TBI. Allogeneic bone marrow is infused on day 0. Patients in both regimens receive cyclosporine and methotrexate as
graft versus host disease prophylaxis.
Patients are followed weekly for 3 months and then monthly for 1 year.
PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients
with high risk myeloid disease will be accrued for this study.
Eligibility
Ages Eligible for Study:
15 Years
-
55 Years,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of:
- Acute myelogenous leukemia
- Complete remission (CR) 1 - ALL except good cytogenetics defined as [(inv16, t(8,21), t(15,17)]
- CR2
- Induction failures
- Relapsed OR
- Acute lymphocytic leukemia (ALL)
- CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm^3, at least
4 weeks to CR1, myeloid phenotype)
- CR2
- Induction failures
- Relapsed OR
- Chronic myelogenous leukemia
- Chronic phase (CP) 1
- Accelerated phase (AP)/CP2 OR
- Chronic lymphocytic leukemia
- At diagnosis - RAI stage III/IV or Binet C
- Must undergo 1 induction regimen
- Relapsed - any stage
- Must have received no more than 3 regimens for diagnosis OR
- Multiple myeloma
- At diagnosis - stage II/III (primary refractory or sensitive)
- Relapsed no more than 2 times - sensitive disease
- Plasma cell leukemia OR
- Myelodysplasia
- All subtypes eligible OR
- Myeloproliferative disorders
- Poor response to medical therapy OR
- Cytogenetic abnormalities
- Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match
- Molecular DR matching required
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 3 times upper limit of normal
- PT/PTT normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- LVEF at least 45% by MUGA scan or echocardiography
- No myocardial infarction within the past 6 months
- No arrhythmias controlled by therapy
Pulmonary:
- FEV_1 at least 50% predicted
- DLCO at least 50% predicted
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No diabetes mellitus or thyroid disease that is not medically controlled
- No psychosocial disorder that would preclude study compliance
- No active serious infections
- HIV negative
- Donor must be HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
Radiotherapy:
Surgery:
Location
and Contact
Information
Florida H. Lee Moffitt Cancer Center and Research Institute, Tampa,
Florida,
33612-9497,
United States; Recruiting
Teresa Field, MD, PhD
813-979-7202 ext. 8744
Study chairs or principal investigators
Teresa Field, MD, PhD, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000067767; MCC-11281; MCC-IRB-4188; NCI-G00-1759
Record last reviewed:
July 2004
Record first received:
June 2, 2000
ClinicalTrials.gov Identifier:
NCT00005797Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29