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Fludarabine and Melphalan Followed by Tacrolimus and Methotrexate in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Relapsed Lymphoma - Article


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Tacrolimus

FK 506; Prograf



Clinical Trial: Fludarabine and Melphalan Followed by Tacrolimus and Methotrexate in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Relapsed Lymphoma

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: A peripheral stem cell transplant or 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 fludarabine together with melphalan followed by tacrolimus and methotrexate may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.

Condition Intervention Phase
adult Hodgkin''''s lymphoma
adult non-Hodgkin''''s lymphoma
 Drug: fludarabine
 Drug: melphalan
 Drug: methotrexate
 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: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Hodgkin''''s Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of a Nonmyeloablative Conditioning Regimen Comprising Fludarabine and Melphalan Followed by Allogeneic Bone Marrow Or Peripheral Blood Stem Cell Transplantation and Immunosuppression Comprising Tacrolimus and Methotrexate in Patients with Relapsed Hodgkin''''s Or Non-Hodgkin''''s Lymphoma After Prior Autologous Stem Cell Transplantation

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (Hodgkin''''s lymphoma vs non-Hodgkin''''s lymphoma).

Patients receive fludarabine IV over 1 hour on days -6 to -2 and melphalan IV over 15-20 minutes on days -3 and -2. Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0. Patients receive oral tacrolimus twice daily beginning on day -3 and continuing until day 100 followed by a taper to day 180. Patients also receive methotrexate IV on days 1, 3, and 5. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study transplantation, patients are followed at 1 and 3 months, 1 year, and then annually for up to 4 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of lymphoma of 1 of the following types:
  • Diffuse large B-cell lymphoma
  • Follicular lymphoma
  • Grades 1, 2, or 3
  • Primary mediastinal lymphoma
  • Mantle cell lymphoma
  • Small lymphocytic lymphoma
  • Hodgkin''''s lymphoma
  • Transformed lymphoma
  • Relapsed after prior autologous bone marrow transplantation (BMT)
  • More than 180 days post BMT
  • Received ≥ 1 course of chemotherapy after BMT relapse
  • Achieved a complete response OR a partial response to chemotherapy
  • Largest residual tumor dimension ≤ 2 cm
  • No clinical or laboratory evidence of CNS involvement by lymphoma
  • HLA-identical donor available, meeting 1 of the following criteria:
  • Sibling donor with 5/6 or 6/6 alleles matching by genotyping
  • No monozygotic identical twins
  • Unrelated donor with 10/10 alleles matching by genotyping

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • LVEF ≥ 40% by MUGA or 2-D echocardiogram (2-D ECHO)
  • No significant cardiac abnormalities by MUGA or 2-D ECHO
  • No uncompensated coronary artery disease by ECG or physical exam
  • None of the following within the past 6 months:
  • Myocardial infarction
  • Unstable angina
  • Uncontrolled atrial fibrillation
  • None of the following within the past 3 months:
  • Severe peripheral vascular disease
  • Venous stasis ulcers
  • Deep venous or arterial thrombosis
  • No uncontrolled hypertension

Pulmonary

  • DLCO (corrected) and total lung capacity ≥ 40% of predicted
  • No requirement for continuous supplemental oxygen

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS
  • No active bacterial, viral, or fungal infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of uncontrolled seizures
  • No diabetic ulcers within the past 3 months

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics
  • No more than 1 prior bone marrow transplantation

Chemotherapy

  • See Disease Characteristics
  • More than 21 days since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery except placement of a venous access device

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00121186


Study chairs or principal investigators

Patrick J. Stiff, MD,  Loyola University   
Scott E. Smith, MD, PhD,  Study Chair,  Loyola University   

More Information

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

Study ID Numbers:  CDR0000435930; SWOG-S0501
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121186
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26

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Page Updated: June 1, 2005
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