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
Inactive

ClinicalTrials ID:NCT01511562

Provider View

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

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

  1. 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.
  2. Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.
  3. Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.
  4. Age- Patients must be between the ages of 18 and 75 years.
  5. Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).
  6. 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)
  7. HIV - Patients must have negative HIV serology.
  8. 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.
  9. Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.
  10. 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

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