Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

Central Nervous System Lymphoma Clinical Trial

Official title:
Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma

Status Completed

Clinical Trial Summary

This is a multicenter open label randomized phase II trial.

Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy:

- Arm A: Methotrexate (MTX) + Cytarabine (Ara-C)

- Arm B: MTX + Ara-C + rituximab

- Arm C: MTX + Ara-C + rituximab + thiotepa.

Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed.

Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy.

Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows:

- Arm D: WBRT 36 Gy +/- boost 9 Gy

- Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician's preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01011920
Study type	Interventional
Source	International Extranodal Lymphoma Study Group (IELSG)
Contact
Status	Completed
Phase	Phase 2
Start date	November 2009
Completion date	March 2017

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04516655` - A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients	Phase 2
Recruiting	`NCT05054426` - Intermediate Dose of IV MTX as CNS Prophylaxis for High Risk DLBCL	Phase 3
Recruiting	`NCT02623010` - Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma	Phase 2
Recruiting	`NCT04548648` - A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas	Phase 2
Active, not recruiting	`NCT00293475` - Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma	Phase 1/Phase 2
Completed	`NCT03342586` - Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity
Terminated	`NCT02420795` - Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma	Phase 1/Phase 2
Completed	`NCT00967200` - Study of Tissue Samples From Patients With Glioma or Other Brain Tumors	N/A
Recruiting	`NCT03684980` - LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma	Early Phase 1
Not yet recruiting	`NCT06213636` - Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).	Phase 1/Phase 2
Recruiting	`NCT04938297` - Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma	Phase 2
Recruiting	`NCT04792489` - DALY II USA/ MB-CART2019.1 for DLBCL	Phase 2
Completed	`NCT01458730` - Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma	Phase 2
Completed	`NCT00153530` - Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)	Phase 4
Recruiting	`NCT04186520` - CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies	Phase 1/Phase 2
Recruiting	`NCT05816746` - Decitabine and Anti-PD-1 in R/R DLBCL	Phase 2
Recruiting	`NCT06031194` - Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
Active, not recruiting	`NCT03962127` - MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
Completed	`NCT03690895` - Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy
Recruiting	`NCT05114330` - Secondary Central Nervous System Lymphoma Registry - Charité

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.