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
You will have follow-up visits for 6 month to up to 4 years after the stem cell transplant.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with CNS involvement by B-cell NHL, relapsed PCNSL, or relapsed PIOL who are alive and progression-free at one year
Yi-Bin A Chen, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|