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Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma

Phase 2
18 Years
Not Enrolling
Mantle Cell Lymphoma

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Trial Information

Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma

Patients will undergo an induction regimen consisting of 1 cycle of cytarabine (3 gm/m2
Intravenously over 1 hour every 12 hours for 8 total doses) and mitoxantrone (10 mg/m2/d
intravenously over 30 minutes daily on days 1, 2, and 3). This will be combined with
Alemtuzumab (anti-CD52 antibody) for 6-8 weeks. If, after this one cycle, patients have not
had progression of disease as noted on physical exam or radiographic scans, they will
proceed to stem cell mobilization with cyclophosphamide. This will be immediately followed
by high dose therapy with stem cell support. Following count recovery, rituximab will be
used for 8 total doses as consolidation therapy. Involved field irradiation may be given
post-transplant to those with localized bulky disease as well. Day -6: Carmustine (BCNU): 15
mg/kg (or 550 mg/m2) IV over 2 hrs. Day -4: Etoposide Day -2: Cyclophosphamide 100 mg/kg in
1 liter D5W over 2 hours.

Inclusion Criteria:

- Must have biopsy proven mantle cell lymphoma confirming mantle cell lymphoma. (Flow
cytometry, and cyclin D1 or t (11;14) tests of disease site should be done if
available at some time in the patient's course before this therapy)

- Radiologic staging studies may be performed up to 6 weeks prior to starting therapy
and not be repeated if the treating physician feels it unnecessary

- No other prior malignancy is permitted except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease-free for one year.

- Age > or = to 18 years of age

- For patients who are in first remission from a prior regimen, at least 3 weeks must
elapse from a prior chemotherapy and at least 1 week from radiation or antibody

Exclusion Criteria:

- Significant medical and/or psychiatric illness which, in the opinion of the
investigators, may compromise any aspect of the planned treatment.

- The patient cannot have been exposed to chemotherapy to treat any of these diseases
(other than mantle cell lymphoma) for at least 3 years prior to entry on this

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate the efficacy in terms of duration of response of intensive induction therapy followed by high dose ablative therapy with autologous progenitor cell support

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David Rizzieri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health Systems


United States: Institutional Review Board

Study ID:




Start Date:

February 1998

Completion Date:

November 2008

Related Keywords:

  • Mantle Cell Lymphoma
  • Intensive Induction
  • High Dose Chemotherapy
  • Bone Marrow Transplantation
  • Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell