Primary Central Nervous System Lymphoma Clinical Trial
Official title:
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Verified date | February 2017 |
Source | Trans-Tasman Radiation Oncology Group (TROG) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2013 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Histologically proven primary CNS lymphoma. - Absence of disease outside the CNS. - ECOG performance status 0-3 - Negative HIV status. - Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L. Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit of normal. - Age >18 and <=70 years. - Patients must give written informed consent. - Corticosteroids prior to histological diagnosis are allowed. Exclusion Criteria: - Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised). - Patients who are pregnant or lactating. - NYHA (New York State Heart Association classification) cardiac failure grade 3 - Macroscopic spinal thecal or spinal cord disease. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | The Canberra Hospital | Garran | Australian Capital Territory |
Australia | Andrew Love Cancer Centre, Geelong Hospital | Geelong | Victoria |
Australia | Royal Brisbane Hospital | Herston | Queensland |
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Calvary Mater Newcastle | Newcastle | New South Wales |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Australia | Mater QRI | South Brisbane | Queensland |
Australia | Premion - Tugun | Tugun | Queensland |
Australia | Westmead Hospital | Wentworthville | New South Wales |
Australia | Illawarra Cancer Care Centre | Wollongong | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
New Zealand | Auckland Hospital | Auckland | |
New Zealand | Christchurch Hospital | Christchurch |
Lead Sponsor | Collaborator |
---|---|
Trans-Tasman Radiation Oncology Group (TROG) | Australasian Leukaemia and Lymphoma Group |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the median and 2 year overall survival. | Estimate of survival at 2 years and at 5 years. | ||
Secondary | Assess acute toxicity. | Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients. | ||
Secondary | Assess functional indices of living in patients with PCNSL. | Analysis will be at 5 years. | ||
Secondary | To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. | Analysis at 3 years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04083066 -
Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma
|
Phase 4 | |
Recruiting |
NCT05681195 -
Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
|
Phase 2 | |
Active, not recruiting |
NCT02313389 -
Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma
|
Phase 3 | |
Recruiting |
NCT02836158 -
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL
|
Phase 2/Phase 3 | |
Recruiting |
NCT02657785 -
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
|
Phase 2/Phase 3 | |
Recruiting |
NCT05135858 -
Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma
|
Phase 1 | |
Completed |
NCT01421524 -
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
|
Phase 1 | |
Active, not recruiting |
NCT00863460 -
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
|
Phase 2 | |
Active, not recruiting |
NCT05036577 -
A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL
|
Phase 1 | |
Recruiting |
NCT04514393 -
Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma
|
Phase 2 | |
Not yet recruiting |
NCT04066920 -
IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL
|
Phase 2 | |
Recruiting |
NCT03733327 -
BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT
|
Phase 2/Phase 3 | |
Recruiting |
NCT00455286 -
a Phase II Study in Primary Central Nervous System Lymphoma
|
Phase 2 | |
Completed |
NCT02301364 -
Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)
|
Phase 2 | |
Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
Completed |
NCT02669511 -
PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
|
Phase 2 | |
Not yet recruiting |
NCT04457869 -
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)
|
Phase 2 | |
Recruiting |
NCT02655744 -
Prospective Neurobehavioral Outcomes Follow-up in Primary CNS Lymphoma Patients Treated With Cranial Radiotherapy Combined With or Without MTX-based Chemotherapy According to the Multidisciplinary Treatment Guidelines Implemented at a Single Institute
|
||
Recruiting |
NCT02399189 -
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
|
Phase 2 | |
Recruiting |
NCT04831658 -
A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma
|
Phase 1/Phase 2 |