Status:
COMPLETED
High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genentech, Inc.
Otsuka America Pharmaceutical
Conditions:
Non-Hodgkin's Lymphoma
CNS Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Current standard treatments for lymphoma involving the central nervous system include chemotherapy or whole brain radiation therapy (WBRT). However, many patients do not respond to this treatment, and...
Detailed Description
If the screening procedures confirm that you are eligible to participate in the research study you will have the following procedures. Stem cell mobilization - this will take place over at least 9 da...
Eligibility Criteria
Inclusion
- 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 \</= 75 years
- Life expectancy \>/= 3 months
- ECOG performance status \</= 2
- Must have adequate organ function as defined by the protocol
Exclusion
- 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 nonmyeloablative)
- 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 rituximab
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01182415
Start Date
June 1 2010
End Date
December 1 2016
Last Update
April 6 2023
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115