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Combination Chemotherapy, Tacrolimus, and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant For Hematologic Cancer - Article


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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

Sponsors and Collaborators: Sidney Kimmel Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00134017

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

Further Study Details: 

OBJECTIVES:

Primary

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).

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

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both
Criteria

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

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00134017


Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-1000,  United States; Recruiting
Leo Luznik, MD  410-502-7732    luznile@jhmi.edu 

Study chairs or principal investigators

Leo Luznik, MD,  Principal Investigator,  Sidney Kimmel Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000440164; JHOC-03121504; JHOC-J0373
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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Page Updated: June 1, 2005
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