Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Gemcitabine; Ifosfamide; Mechlorethamine; Melphalan; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Procarbazine; Vincristine; Vinorelbine

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