Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: cyclophosphamide; cyclosporine; fludarabine phosphate; gemcitabine hydrochloride; ifosfamide; mechlorethamine hydrochloride; melphalan; methotrexate; mycophenolate mofetil; prednisone; procarbazine hydrochloride; vincristine sulfate; vinorelbine tartrate; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation; nonmyeloablative allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; umbilical cord blood transplantation; total-body irradiation
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Cyclophosphamide; Melphalan; Ifosfamide; Mechlorethamine; Gemcitabine; Methotrexate; Fludarabine; Fludarabine phosphate; Vincristine; Vinorelbine; Procarbazine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 13 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; childhood lymphocyte depletion Hodgkin lymphoma; childhood mixed cellularity Hodgkin lymphoma; childhood nodular sclerosis Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma

Summary:

      RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of
      cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem
      cells. When the healthy stem cells from a donor are infused into the patient they may help
      the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
      Sometimes the transplanted cells from a donor can make an immune response against the body's
      normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after
      transplant may stop this from happening.

      PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor
      stem cell transplant works in treating patients with relapsed or high-risk primary refractory
      Hodgkin lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed classical Hodgkin lymphoma, including CD20+ disease

               -  No lymphocyte predominant histology

          -  Primary refractory or relapsed disease with all 3 risk factors, failed platinum-based
             chemotherapy, or disease relapsed more than 100 days after autologous stem cell
             transplantation, proven by biopsy or fine-needle aspiration (cytology) of an involved
             site

               -  Risk factors are defined as B-symptoms, extranodal sites of disease, and disease
                  remission lasting < 1 year after first-line therapy

          -  Failed doxorubicin hydrochloride or mechlorethamine hydrochloride-containing
             front-line therapy

          -  Fludeoxyglucose F 18-PET scan demonstrating PET-avid disease

          -  No more than 2 prior salvage chemotherapy regimens (for patients proceed to allogeneic
             hematopoietic stem cell transplantation [AHSCT])

          -  Donor available meeting 1 of the following criteria (for patients proceed to AHSCT):

               -  HLA-matched or one allele mismatched related donor

                    -  Genotypically or phenotypically matched at ≥ 9/10 of the A, B, C, DRB1, and
                       DQB1 loci, as tested by high resolution

                    -  Peripheral blood stem cells (PBSC) collected

               -  HLA-matched unrelated donor

                    -  Matched at ≥ 9/10 (allele mismatch only) of the A, B, C, DRB1, and DQB1
                       loci, as tested by high resolution

                    -  PBSC or bone marrow collected

               -  Umbilical cord blood (2 units)

                    -  must be ≥ 4/6 HLA-A, B antigen, and DRB1 allele matched with recipient

        PATIENT CHARACTERISTICS:

          -  Platelet count > 50,000/mm^3

          -  ANC > 1,000/mm^3

          -  Cardiac ejection fraction > 50% (for patients ≥ 18 years of age)

          -  Fractional shortening > 50% by echocardiogram* (for patients < 18 years of age)

          -  Adjusted diffusing capacity > 50% on pulmonary function testing*

          -  Serum creatinine < 1.5 mg/dL

          -  Creatinine clearance ≥ 50 mL/min

          -  Total bilirubin < 2.0 mg/dL in the absence of a history of Gilbert disease

          -  HIV I and II negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Karnofsky performance status (PS) ≥ 70% or Lansky PS ≥ 70% (for patients proceed to
             AHSCT)

          -  No active and uncontrolled infection at time of transplantation including active
             infection with Aspergillus or other mold (for patients proceed to AHSCT) NOTE:
             *measured since last chemotherapy

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior allogeneic transplantation

          -  No more than 1 prior autologous transplantation

          -  No inability to complete planned cytoreduction due to therapy complications