Auto Stem Cell Transplant for Lymphoma Patients
Auto Stem Cell Transplant for Lymphoma Patients
This is a phase II study of autologous transplant for patients with Hodgkin (HL) and
 non-Hodgkin lymphomas (NHL) including those who are HIV positive.
Inclusion Criteria:

 -  Eligible Diseases

 1. Non-Hodgkin's Lymphoma (NHL)

 -  Patients with chemo-sensitive histologically confirmed NHL will be eligible
 for this treatment protocol contingent on histologic sub-classification.

 -  Patients in partial or complete remission following cell therapy will also
 be eligible.

 -  NHL patients with resistant or refractory lymphoma (no PR following up to
 three cycles of combination chemotherapy) will not be eligible for
 transplant in this trial.

 -  Lymphoblastic Lymphoma:

 1. All patients will be eligible in second or greater complete remission
 (CR) or first or subsequent partial remission (PR)

 2. Patients with any high-risk features will be eligible in first complete
 remission

 3. High risk features include: Stage IV, LDH >2 x upper limit of normal, ≥
 2 extranodal sites

 -  Mature B-cell Lymphoma

 1. Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2

 2. Diffuse Large B-Cell Lymphoma: in ≥ CR2 or ≥ PR1; a high intermediate
 or high IPI (≥ 2 for age-adjusted IPI or ≥3 for IPI) at diagnosis and
 double-hit or triple-hit lymphoma will be eligible in first CR;
 transformed lymphoma from FL (or other indolent lymphoma) or chronic
 lymphocytic leukemia will be eligible if chemosensitive and bone marrow
 is negative

 3. Mantle Cell Lymphoma: in first or greater CR or PR

 4. Burkitt's/Burkitt's like: all patients except localized lymphoma will
 be eligible any time after initial therapy (after achievement of first
 complete remission), or in partial remission if they fail to achieve
 CR; patients with localized (stage I or Ziegler stage A) will be
 eligible only if they fail to achieve CR1 or after relapse

 -  Mature T-Cell Lymphoma

 1. Chemosensitive T-cell lymphomas including Primary T-cell not otherwise
 specified angioimmunoblastic, and ALK-positive anaplastic large cell,
 will be eligible after initial therapy, whether or not CR is achieved.

 2. Mycosis fungoides/Sezary syndrome will be eligible in ≥CR2/PR2

 2. Hodgkin Lymphoma (HL)

 -  Patients with histologically proven HL will be eligible for transplantation
 after failing prior therapy.

 -  Patients with resistant disease (initial or at relapse): those who fail to
 achieve an objective partial response to three cycles of combination
 non-cross resistant chemotherapy will not be eligible for transplant in this
 trial.

 -  For stage I/II patients treated with primary chemotherapy-radiation, they
 must have failed (no CR or progression after CR) at least one salvage
 combination chemotherapy treatment regimen

 -  For advanced (stage III/IV) Hodgkin disease, patients must have failed an
 Adriamycin containing regimen (ABVD) or an alternative non-cross resistant
 regimen (e.g. MOPP)

 -  Patients with any high-risk features will also be eligible, including those
 who:

 1. fail to achieve complete remission with initial combination
 chemotherapy

 2. have bulky disease after initial therapy (chemotherapy or radiation)
 defined as residual mediastinal mass ≥ 5 cm or other residual mass ≥ 10
 cm accompanied by other features of persisting disease (e.g., PET scan
 positive; high LDH; enlarging on serial x-rays or biopsy positive) will
 be eligible - if feasible, persistent disease should be proven by
 biopsy

 -  Patients should receive chemotherapy to attempt to achieve CR or minimal
 disease state for all patients pre-transplantation. The use of up to three
 cycles of non-cross resistant combination chemotherapy is advised.

 -  Residual areas of limited disease should be considered for radiotherapy
 after and not prior to transplantation.

 3. HIV positive patients who are otherwise eligible for this study may be enrolled
 if they meet the following requirements:

 -  Are seen in the infectious disease (ID)/HIV clinic prior to enrollment on
 study for the purpose of determining eligibility and for local coordination
 of HIV care during the peri-transplant period.

 -  Are on maximally active anti-HIV regimen to control disease as determined
 appropriate by the ID/HIV physicians. For the majority of patients, this
 will be a highly active anti-retroviral therapy (HAART)-type therapy
 including a protease inhibitor.

 -  CD4+ ≥ 50/µL

 -  HIV RNA viral load ≤ 100,000 copies per mL on each of samples 4 weeks apart.
 The most recent level must be within 30 days of enrollment.

 -  Performance Status: Karnofsky Performance Status ≥ 80% for patients ≥ 16 years of age
 or Lansky Play Score ≥ 80 for patients < 16 years of age. Note: if poor performance
 status is due to lymphoma - KPS ≥ 60% or LPS ≥ 60 is acceptable

 -  Organ Function

 1. No evidence of serious organ dysfunction that is not attributable to tumor
 including:

 1. Hematologic:

 -  hemoglobin > 8 gm/dL

 -  WBC > 2.5 x 109/L with an ANC > 1.5 x 109/L off G-CSF or GM-CSF for 10 days
 or Neulasta for 21 days

 -  platelets > 100 x 109/L without transfusion

 -  bone marrow cellularity of > 20% with <5% involvement with tumor

 2. Renal: GFR > 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age

 3. Hepatic: no history of severe prior or ongoing chronic liver disease. Total
 bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase <5x upper limit of normal

 4. Cardiac: free of symptoms of uncontrolled cardiac disease including unstable
 angina, decompensated congestive heart failure, or arrhythmia. The ejection
 fraction by gated cardiac blood flow scan (MUGA) or Echocardiogram must be >40%

 5. Pulmonary: no significant obstructive airways disease (FEV1 must be ≥ 50%) and
 must have acceptable diffusion capacity (corrected DLCO > 50% of predicted)

 6. Central Nervous System: Patients with a history of CNS involvement by lymphoma or
 with relapsed primary CNS lymphoma will be eligible for Cy/TBI arm. Patients with
 active CNS disease are eligible if they have completed a standard treatment for
 CNS lymphoma and have no evidence of progressive CNS disease at the time of
 enrollment

 -  Other Inclusion Criteria

 1. At least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas

 2. Women of child bearing potential and sexually active males with partners of child
 bearing potential must agree to use adequate birth control for the duration of
 treatment

 3. Patients who are carriers of Hepatitis B will be included in this study

 4. Voluntary written consent

 Exclusion Criteria:

 -  Pregnant or breastfeeding: Females of childbearing potential must have a blood test or
 urine study within 14 days prior to registration to rule out pregnancy

 -  Eligible for any higher priority transplant protocols

 -  Chemotherapy resistant disease

 -  Unrelated active infection