Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01511562|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : August 17, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: carmustine Drug: cytarabine Drug: etoposide Drug: thiotepa Procedure: stem cell transplant Drug: G-CSF||Phase 2|
To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide
- To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine
- To determine diffusion MRI metrics (ADCmini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine brain FDG-PET metrics (tumor SUV and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)
- To determine whether reduction in tumor SUV by > 25% on brain FDG-PET/CT after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101)
- To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)
- To determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced)
- To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)
- To determine whether CSF proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 (interleukin 10) and C3 (complement component 3)
- To assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International PCNSL Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||October 2026|
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
Procedure: stem cell transplant
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
- progression free survival [ Time Frame: Up to 10 years ]
- event free survival [ Time Frame: Up to 10 years ]
- number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 10 years ]
- overall survival [ Time Frame: Up to 10 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511562
|Study Chair:||Tracy Batchelor, MD, MPH||Massachusetts General Hospital|
|Responsible Party:||Alliance for Clinical Trials in Oncology|
|Other Study ID Numbers:||
CDR0000721927 ( Registry Identifier: NCI Physician Data Query )
NCI-2012-00110 ( Registry Identifier: NCI Clinical Trial Reporting Program )
|First Posted:||January 18, 2012 Key Record Dates|
|Last Update Posted:||August 17, 2021|
|Last Verified:||August 2021|
primary central nervous system non-Hodgkin lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating