Clinical trial · Interventional
Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| stem cell transplant | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm I
- description
- Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
- interventionNames
- Drug: carmustine
- Drug: thiotepa
- Procedure: stem cell transplant
- Drug: G-CSF
- type
- OTHER
- label
- Arm II
- description
- Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
- interventionNames
- Drug: cytarabine
- Drug: etoposide
- Drug: G-CSF
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBatchelor TT, Giri S, Ruppert AS, Geyer SM, Smith SE, Mohile N, Swinnen LJ, Friedberg JW, Kahl BS, Bartlett NL, Hsi ED, Cheson BD, Wagner-Johnston N, Nayak L, Leonard JP, Rubenstein JL. Myeloablative vs nonmyeloablative consolidation for primary central nervous system lymphoma: results of Alliance 51101. Blood Adv. 2024 Jun 25;8(12):3189-3199. doi: 10.1182/bloodadvances.2023011657. PMID 38598710