Tacrolimus |
FK 506; Prograf |
Clinical Trial: Combination Chemotherapy, Tacrolimus, and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant For Hematologic Cancer
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) August 2005
Purpose
RATIONALE: Drugs used in chemotherapy, such as busulfan and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a donor bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. A donor bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body''''s normal cells. Giving cyclophosphamide together with tacrolimus and mycophenolate mofetil after a bone marrow transplant may prevent this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
| Condition | Intervention |
|---|---|
| childhood Hodgkin''''s lymphoma childhood non-Hodgkin''''s lymphoma chronic myeloproliferative disorders Leukemia Lymphoma plasma cell neoplasm | Drug: busulfan Drug: cyclophosphamide Drug: mycophenolate mofetil Drug: tacrolimus 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: supportive care/therapy |
MedlinePlus related topics: Bone Marrow Diseases; Hodgkin''''s Disease; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study of Myeloablative Conditioning Chemotherapy Comprising Busulfan and Cyclophosphamide Followed By Allogeneic Bone Marrow Transplantation and Immunosuppression Comprising High-Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Patients With High-Risk Hematologic Malignancies
OBJECTIVES:
Primary
- Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies.
- Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen.
- Determine other toxic effects of this regimen in these patients.
Secondary
- Determine immune reconstitution in patients treated with this regimen.
- Determine disease control in patients treated with this regimen.
OUTLINE: This is a pilot study. Patients are stratified according to age (≤ 19 years old vs > 19 years old).
- Myeloablative conditioning chemotherapy: Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1.
- Allogeneic bone marrow transplantation: Patients undergo allogeneic bone marrow transplantation on day 0.
- Patients receive 1 of the following immunosuppressive treatment regimens:
- Regimen 1: Patients receive high-dose cyclophosphamide IV over 1 hour on day 3.
- Regimen 2: Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4.
- Regimen 3: Patients receive high-dose cyclophosphamide as in regimen 2 and oral mycophenolate mofetil three times daily on days 5-35.
- Regimen 4: Patients receive high-dose cyclophosphamide as in regimen 2 and mycophenolate mofetil as in regimen 3. Patients also receive tacrolimus IV or orally twice daily on days 5-50.
After completion of study transplantation, patients are followed at 30 and 60 days, 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 30-60 patients (approximately 5 per immunosuppressive treatment regimen) will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- AML beyond first complete remission (CR1)
- Refractory AML
- AML arising from myelodysplastic syndromes (MDS)
- Secondary AML
- MDS
- Refractory anemia with excess blasts with > 10% blasts in bone marrow
- Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- ALL in CR1 with 1 of the following high-risk features:
- Philadelphia chromosome (Ph)-positive disease
- Less than 1 year of age at diagnosis
- Cytogenetic abnormalities involving chromosome 11q23
- ALL beyond CR1
- Refractory ALL
- Chronic myeloid leukemia beyond first chronic phase
- Chronic myelomonocytic leukemia
- Chronic lymphocytic leukemia
- Stage III-IV disease
- Does not meet criteria for other bone marrow transplantation (BMT) studies
- Myeloproliferative disorders
- Ph-negative disease
- Hodgkin''''s or non-Hodgkin''''s lymphoma
- Chemotherapy-resistant disease
- Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
- Multiple myeloma
- Stage II or III disease
- Very high-risk disease
- Having an unrelated donor is considered a high-risk condition
- Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
- Bone marrow donor available, meeting 1 of the following criteria:
- Genotypically HLA-identical sibling
- Phenotypically matched first-degree relative
- Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1
PATIENT CHARACTERISTICS:
Age
- 6 months to 65 years
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent dexamethasone as an antiemetic during immunosuppression therapy
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)
Location and Contact Information
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-1000, United States; Recruiting
Leo Luznik, MD, Principal Investigator, Sidney Kimmel Cancer Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: August 23, 2005
Record first received: August 22, 2005
ClinicalTrials.gov Identifier: NCT00134017
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30

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