Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01511562
First received: January 13, 2012
Last updated: June 20, 2016
Last verified: June 2016

January 13, 2012
June 20, 2016
September 2012
October 2026   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Two-year PFS [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01511562 on ClinicalTrials.gov Archive Site
  • event free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • EFS and OS estimated for each arm by Kaplan-Meier method, and compared between the two arms using the log-rank test [ Designated as safety issue: No ]
  • Toxicity rate compared between the arms using Fisher's exact method [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.

Primary Objective:

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

Secondary Objectives:

  1. 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
  2. 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
  3. To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine
  4. 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)
  5. 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)
  6. To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)
  7. 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)
  8. To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)
  9. 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)
  10. To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)
  11. 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)
  12. 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)
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: carmustine
    Given IV
  • Drug: cytarabine
    Given IV
  • Drug: etoposide
    Given IV
  • Drug: thiotepa
    Given IV
  • Procedure: stem cell transplant
  • Drug: G-CSF
  • Arm I
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
    Interventions:
    • Drug: carmustine
    • Drug: thiotepa
    • Procedure: stem cell transplant
    • Drug: G-CSF
  • Arm II
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
    Interventions:
    • Drug: cytarabine
    • Drug: etoposide
    • Drug: G-CSF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
Not Provided
October 2026   (final data collection date for primary outcome measure)
  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. Patients must have no isolated ocular lymphoma.
  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. Due to the unknown teratogenic potential of this regimen, pregnant or nursing patients may not be enrolled. 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 due to the teratogenic potential of the therapy utilized in this trial. 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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact: Tracy Batchelor, MD, MPH 617-643-2591
United States
 
NCT01511562
CALGB-51101, CALGB-51101, CDR0000721927
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Tracy Batchelor, MD, MPH Massachusetts General Hospital
Alliance for Clinical Trials in Oncology
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP