Study on Chemotherapy With or Without Stem Cell Transplant for Treating Central Nervous System B-Cell Lymphoma
Sponsor: Alliance for Clinical Trials in Oncology
Sponsor score: 0
ClinicalTrials ID:NCT01511562
This clinical trial is exploring whether adding a stem cell transplant to chemotherapy is more effective than chemotherapy alone for treating primary CNS B-cell lymphoma, a type of brain cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to determine the effects of combining chemotherapy with a stem cell transplant compared to using chemotherapy alone in treating primary CNS B-cell lymphoma. Researchers are trying to find out which treatment approach is better for patients with this type of brain cancer.
Description
The study has several goals:
- The main goal is to compare how long patients live without the cancer getting worse when treated with chemotherapy and a stem cell transplant versus chemotherapy alone.
- Researchers will also compare how long patients live without any major health events and overall survival between the two treatment groups.
- The study will look at the side effects of each treatment approach.
- Researchers will use advanced imaging techniques like MRI and PET scans to see how well the treatments are working and predict outcomes.
- They will also study specific biological markers in the tumor and spinal fluid to see if they can predict how well patients will do.
- The study will assess patients' brain function and quality of life after treatment to understand long-term effects.
Eligibility Criteria
- Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid.
- Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.
- Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.
- Age- Patients must be between the ages of 18 and 75 years.
- Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).
- Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
- HIV - Patients must have negative HIV serology.
- Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation.
- Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.
- Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT < 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | 91505 | Burbank | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
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