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Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma

Phase 2
59 Years
Not Enrolling
Graft Versus Host Disease, Lymphoma

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Trial Information

Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma


- 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

- 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


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

- 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



- Under 60

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Bilirubin less than 2 mg/dL

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


- Creatinine less than 2 mg/dL


- DLCO at least 40%

- No symptomatic pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative


Biologic therapy:

- No prior bone marrow transplantation


- See Disease Characteristics

- No more than 2 prior chemotherapy regimens

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy


- No concurrent radiotherapy to bulky sites


- See Disease Characteristics

Type of Study:


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:


Principal Investigator

Koen Van Besien, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




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



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