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A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL


OBJECTIVES:

- Compare the 1-year overall survival rate of patients with relapsed low-grade
non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and
total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic
peripheral blood stem cell transplantation and donor lymphocyte infusions.

- Compare the toxic effects of these regimens in these patients.

- Compare the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with these regimens.

- Compare the 1-year treatment-related mortality and infectious complications in patients
treated with these regimens.

- Compare the efficacy of these treatment regimens, in terms of 1-year disease-free
survival, of these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease, age (less than 55 vs over 55), and participating transplantation center. Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body
irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT)
on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral
cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral
mycophenolate mofetil twice daily on days 0-28.

- Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on
days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis
comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and
then orally on days -2 to 90 followed by a taper on days 90-150.

At approximately day 180, patients with persistent disease, evidence of T-cell chimerism,
and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.

Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every
6 months for 1 year.

Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia OR

- Diagnosis of non-Hodgkin's lymphoma

- Lymphoplasmacytic lymphoma

- Grade I follicular small cleaved cell lymphoma

- Grade II follicular mixed cell lymphoma

- Diffuse small cleaved cell lymphoma

- Small lymphocytic lymphoma

- Relapsed after at least 1 course of prior therapy

- Availability of a 6/6 HLA A, B, and DR identical sibling donor

- Nonmyeloablative transplantation candidate

- No clinically significant effusions or ascites that would preclude administration of
methotrexate

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- At least 6 months

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 3 mg/dL

Renal:

- Creatinine no greater than 2 mg/dL

Cardiovascular:

- LVEF at least 40% on MUGA scan or echocardiogram

Pulmonary:

- DLCO at least 50% of predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled bacterial, viral, fungal, or parasitic infection

- HIV1 and HIV2 negative

- No other active malignancy except basal cell skin cancer

- No recent history of drug or alcohol abuse

- No other primary disease or comorbid illness that would severely limit life
expectancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- Prior autologous bone marrow transplantation allowed if disease has progressed after
transplantation

- No entry on study as part of a tandem autologous transplantation followed by
nonmyeloablative allograft protocol

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Robert H. Collins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069462

NCT ID:

NCT00041288

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Waldenstrom macroglobulinemia
  • refractory chronic lymphocytic leukemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Medical College of WisconsinMilwaukee, Wisconsin  53226
Massey Cancer CenterRichmond, Virginia  23298-0037
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Hackensack University Medical CenterHackensack, New Jersey  07601
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Florida Hospital Cancer InstituteOrlando, Florida  32804
James P. Wilmot Cancer CenterRochester, New York  14642
Oregon Cancer InstitutePortland, Oregon  97201-3098
Rocky Mountain Cancer CentersThornton, Colorado  80260
Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342-1601
University of Missouri Kansas City School of MedicineKansas City, Missouri  64111
Delaware Clinical & Laboratory PhysiciansNewark, Delaware  19713
Texas Transplant InstituteSan Antonio, Texas  78229