S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-12-31

Brief Summary

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RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant 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.

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Detailed Description

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OBJECTIVES:

* Determine the 1-year progression-free and overall survival rate in patients with relapsed Hodgkin's or non-Hodgkin's lymphoma after prior autologous stem cell transplantation treated with 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.
* Determine treatment-related mortality in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine engraftment of donor hematopoietic stem cells, as measured by hematopoietic recovery and donor-derived hematopoiesis (determined by T cell and neutrophil specific chimerism) at 2, 3, 6, and 12 months, in patients treated with this regimen.
* Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.

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 7. 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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nonmyeloablative allogeneic stem cell transplant

Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.

Group Type EXPERIMENTAL

fludarabine phosphate

Intervention Type DRUG

30 mg/m\^2 on days -6 to -2 (2-6 days before transplant).

melphalan

Intervention Type DRUG

70 mg/m\^2 on days -3 and -2 (2-3 days before transplant).

methotrexate

Intervention Type DRUG

5 mg/m\^2 on days 1, 3, and 7 post-transplant.

tacrolimus

Intervention Type DRUG

0.03 mg/kg bid on days -3 to 100 post-transplant.

allogeneic bone marrow transplantation

Intervention Type PROCEDURE

if donor bone marrow stem cells are harvested

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

if donor peripheral blood stem cells are harvested

Interventions

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fludarabine phosphate

30 mg/m\^2 on days -6 to -2 (2-6 days before transplant).

Intervention Type DRUG

melphalan

70 mg/m\^2 on days -3 and -2 (2-3 days before transplant).

Intervention Type DRUG

methotrexate

5 mg/m\^2 on days 1, 3, and 7 post-transplant.

Intervention Type DRUG

tacrolimus

0.03 mg/kg bid on days -3 to 100 post-transplant.

Intervention Type DRUG

allogeneic bone marrow transplantation

if donor bone marrow stem cells are harvested

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

if donor peripheral blood stem cells are harvested

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick J. Stiff, MD

Role: STUDY_CHAIR

Loyola University

Scott E. Smith, MD, PhD, FACP

Role: STUDY_CHAIR

Loyola University

Locations

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Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status