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Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

PFS rate at 1 year.

Outcome Time Frame:

1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

Safety Issue:

No

Principal Investigator

Patrick J. Stiff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

CDR0000435930

NCT ID:

NCT00121186

Start Date:

July 2005

Completion Date:

December 2011

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent mantle cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Southwest Medical CenterLiberal, Kansas  67901
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Highland Hospital of RochesterRochester, New York  14620
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529