Phase II Trial of Hihg-Dose Thiotepa, Busulfan, Cyclophosphamide, and Rituximab With Autologous Stem Cell Transplantation for Patients With CNS Involvement by Non-Hodgkin's Lymphoma or Primary CNS Lymphoma
18 Years
75 Years
Both
Non-Hodgkin's Lymphoma, CNS Lymphoma
Trial Information
Phase II Trial of Hihg-Dose Thiotepa, Busulfan, Cyclophosphamide, and Rituximab With Autologous Stem Cell Transplantation for Patients With CNS Involvement by Non-Hodgkin's Lymphoma or Primary CNS Lymphoma
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 days to prepare you to donate
your stem cells for your autologous transplant. The drugs cytarabine, rituximab and
Neupogen (G-CSF) will be given. You will be in the hospital for 2 days to receive the
cytarabine infusions (and the 1st rituximab infusion of day 1 of stem cell mobilization).
Then you will be discharged. You will receive the Neupogen injections as an outpatient.
Stem cell collection (leukapheresis) - When your doctor determines that your stem cell count
is high enough you will have your stem cells collected by a procedure called leukapheresis.
Leukapheresis is performed by collecting blood from a vein and processing it through a
machine that removes the stem cells that are needed to produce bone marrow. The rest of the
blood is returned to you through another vein. The harvested stem cells will be frozen and
stored. These cells will be returned to you after you complete the conditioning regimen
with high dose chemotherapy.
Conditioning regimen (high dose chemotherapy) - You will enter the hospital for the
conditioning regimen and stay for about 30 days after you receive your stem cell transplant.
The conditioning regimen to help kill cancer cells before your stem cell transplant will
take place over 9 days. All drugs will be given intravenous (through an IV).
Infusion of stem cells (stem cell transplant) - Your cells will be given to you through your
vein, similar to an IV infusion. The infusion usually takes several hours.
After you are discharged, you will be asked to return at about 4 weeks, 8 weeks, 12 weeks
and 14 weeks after the stem cell transplant. At each visit you will have a physical exam,
questions to measure your mental functioning, blood tests. About 14 weeks after the stem
cell transplant you will have an eye exam, echocardiogram, lung function tests, whole body
PET-CT scan, brain MRI or CT scan, MRI or CT of spinal cord (for patients who may have
lymphoma in the spinal cord), collection of cerebral spinal fluid, and bone marrow
aspiration.
You will have follow-up visits for 6 month to up to 4 years after the stem cell transplant.
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients with CNS involvement by B-cell NHL, relapsed PCNSL, or relapsed PIOL who are alive and progression-free at one year
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Yi-Bin A Chen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
09-444
NCT ID:
NCT01182415
Start Date:
June 2010
Completion Date:
March 2015
Related Keywords:
- Non-Hodgkin's Lymphoma
- CNS Lymphoma
- CNS involvement
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
