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Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma


Phase 2
N/A
59 Years
Not Enrolling
Both
Graft Versus Host Disease, Lymphoma

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Trial Information

Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma


OBJECTIVES:

- Determine the long term disease-free survival of patients with mantle cell lymphoma
treated with etoposide, carmustine, melphalan, and cytarabine followed by allogeneic
peripheral blood stem cell transplantation.

- Determine the incidence of molecular remissions in these patients treated with this
regimen.

- Correlate the persistence of minimal residual disease with clinical outcome in these
patients treated with this regimen.

- Determine the effect of donor lymphocytes in patients with progressive disease after
treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and
cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and
melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem
cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over
24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV
over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis.
Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and
continuing until blood counts recover.

Patients with no active GVHD who have persistent disease on day 150 or progressive disease
at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients
may receive additional donor lymphocytes at least 8 weeks later if disease persists.

Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma of any stage with at least 1 of the
following:

- Immunophenotype with expression of CD5 and CD19 and absence of CD23

- Cytogenetic analysis with presence of t(11;14)

- Overexpression of cyclin D1

- Rearrangement of BCL1 gene

- Bone marrow biopsy required

- No needle or core biopsy as sole means of diagnosis

- First remission allowed if at least 1 of the following poor prognostic
characteristics present:

- International Prognostic Index (IPI) score higher than 1 defined by the
following risk factors:

- Performance status higher than 1

- Elevated LDH

- Presence of more than 1 extranodal site

- Stage III or IV disease

- Blastic variant of mantle cell lymphoma*

- Complex karyotypes (i.e., cytogenetic abnormalities different from or in
addition to t(11;14)*

- Proliferative index more than 10%*

- Presence of p53 mutations NOTE: *Regardless of IPI score

- Failure of initial therapy with anthracycline-containing regimen allowed

- Failure to achieve clinical complete remission after initial therapy OR

- Recurrent disease after initial therapy

- HLA matched (6/6) sibling donor by serologic typing (A, B, or DR)

- Any age

- No syngeneic (identical twin) donor

- No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age:

- Under 60

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2 mg/dL

- AST and ALT no greater than 3 times upper limit of normal

Renal:

- Creatinine less than 2 mg/dL

Pulmonary:

- DLCO at least 40%

- No symptomatic pulmonary disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow transplantation

Chemotherapy:

- See Disease Characteristics

- No more than 2 prior chemotherapy regimens

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy

Radiotherapy:

- No concurrent radiotherapy to bulky sites

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Koen Van Besien, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000068324

NCT ID:

NCT00006747

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Lymphoma
  • graft versus host disease
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • Graft vs Host Disease
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
University of Illinois at ChicagoChicago, Illinois  60612