Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral
      stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and
      kill more cancer cells.

      PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation
      with that of autologous peripheral stem cell transplantation in treating patients who have
      non-Hodgkin's lymphoma or Hodgkin's disease.
    

Detailed description: 
      OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in
      patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic
      vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of
      these 2 regimens in these patients.

      OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g.,
      dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone,
      high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone
      (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic
      peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical
      sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous
      PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised
      of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and
      etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed
      weekly for 3 months, then monthly for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.
    

Intervention name(s): cyclophosphamide; etoposide; BCNU
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cyclophosphamide will be given at a dose of 1500 mg/m2/day IV over 1.0 hour on days -6, -5, -4, and -3.; Etoposide will be given at a dose of 600 mg/m2/day over 3.0 hours on days -6, -5, and -4.; BCNU will be given at a dose of 150 mg/m2/day in 500 cc D5W over 3.0 hours on days -6, -5, and -4
Other intervention name(s): vp-16; Carmustine
Intervention MeSH terms: Cyclophosphamide; Carmustine; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma