Intensive Induction Therapy Followed by High Dose Chemo and BM Transplant for Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00586755
First received: December 21, 2007
Last updated: December 26, 2008
Last verified: December 2008
  Purpose

Patients with mantle cell lymphoma have a grave prognosis. They usually have an initial response to therapy, however progress early in the course of the disease and have very poor survival. We hypothesize that the emergence of drug resistance is responsible for this early failure of therapy and therefore intensive therapy at induction followed by high dose therapy immediately may produce a better outcome.


Condition Intervention Phase
Mantle Cell Lymphoma
Procedure: High Dose Intensive Induction and BMT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Induction Therapy Followed by Early High Dose Chemotherapy and Bone Marrow Transplantation for Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Evaluate the efficacy in terms of duration of response of intensive induction therapy followed by high dose ablative therapy with autologous progenitor cell support [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the response to the induction regimen [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assess response to the transplant phase of therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Monitor toxicity of the trial [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: February 1998
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Patients will undergo induction regimen and stem cell mobilization with cyclophosphamide. This will be immediately followed by high dose therapy with stem cell support.
Procedure: High Dose Intensive Induction and BMT
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 therapy.

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 protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586755

Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: David Rizzieri, MD Duke University Health Systems
  More Information

No publications provided

Responsible Party: David Rizzieri, Duke University Health Systems
ClinicalTrials.gov Identifier: NCT00586755     History of Changes
Other Study ID Numbers: 2165
Study First Received: December 21, 2007
Last Updated: December 26, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Intensive Induction
High Dose Chemotherapy
Bone Marrow Transplantation
Mantle Cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 17, 2014