Clinical Trial Details
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NCT01182415 : High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

- One of the following clinical criteria:secondary CNS NHL; synchronous CNS NHL;
relapsed PCNSL; relapsed IOL; PCNSL or IOL which has only achieved a PR after
adequate initial therapy

- Must have CNS or intraocular involvement by NHL

- Subjects with secondary CNS NHL, relapsed PCNSL, or relapsed IOL will have received
Salvage therapy for their CNS disease

- Subjects with synchronous CNS NHL will have received primary therapy including
CNS-directed therapy

- Must demonstrate a partial or complete response of the CNS and systemic disease to
pre-enrollment therapy, and must be in PR or CR at the time of enrollment

- Age >/= 18 and
- Life expectancy >/= 3 months

- ECOG performance status
- Must have adequate organ function as defined by the protocol

Exclusion Criteria:

- Stable or progressive CNS or systemic disease (SD orPD) at the time of enrollment

- Systemic or intrathecal chemotherapy or radiotherapy within 2 weeks prior to starting
therapy on study

- Actively receiving any other study agents aimed to treat their disease

- A prior HDT-ASCT or allogeneic stem cell transplant (myeloablative or

- Burkitt's lymphoma or acute lymphoblastic lymphoma

- A history of severe allergic reactions attributed to compounds of similar chemical or
biologic composition to cytarabine, thiotepa, busulfan, cyclophosphamide, or

- Serious uncontrolled concurrent illness

- Any evidence of prior exposure to Hepatitis B virus

- HIV-positive

- Pregnant or lactating

- A history of malignancy other than NHL or PCNSL unless disease-free for at least 5
years and are deemed by the investigator to be at low risk for recurrence of that
malignancy. Individuals with the following cancers are eligible if diagnosed and
treated within the past 5 years: cervical cancer in situ, and basal cell or squamous
cell carcinoma of the skin
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