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 August 2015 by Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: January 13, 2012
Last updated: August 28, 2015
Last verified: August 2015

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.

Condition Intervention Phase
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: thiotepa
Procedure: transplant
Procedure: filgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Two-year PFS [ Time Frame: At 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Toxicity rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • OS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2012
Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (carmustine, thiotepa, filgrastim, transplant)

CONSOLIDATION THERAPY: Beginning 2-4 weeks after stem cell mobilization, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 and thiotepa IV over 2 hours every 12 hours on days -5 to -4. Beginning on day 4, patients also receive filgrastim SC once a day and continuing until absolute neutrophil count recovers.

STEM CELL RESCUE: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

Drug: carmustine
Given IV
Drug: thiotepa
Given IV
Procedure: transplant
Undergo autologous HSCT
Procedure: filgrastim
Given SC
Experimental: Arm II (cytarabine, etoposide and filgrastim)
Beginning at least 8 weeks after completion of induction therapy, patients receive cytarabine IV over 2 hours every 12 hours on days 1-4, and etoposide IV continuously over 96 hours on days 1-4. Beginning on day 14, patients also receive filgrastim SC once a day and continuing until absolute neutrophil count recovers.
Drug: cytarabine
Given IV
Drug: etoposide
Given IV
Procedure: filgrastim
Given SC

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:

    • Brain biopsy or resection
    • Cerebrospinal fluid
    • Vitreous fluid
  • No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS
  • No isolated ocular lymphoma
  • No prior chemotherapy or radiation therapy for lymphoma


  • Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years)
  • 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)
  • Negative human immunodeficiency virus (HIV) serology
  • Patients must have negative hepatitis C virus (HCV) serology (unless hepatitis B virus antibody [HBsAb] positive patient has recently received hepatitis B virus [HBV] vaccine, in this case hepatitis B core antibody [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; primary central nervous system lymphoma (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
  • Patient must have no history of organ transplantation or ongoing immunosuppressant therapy
  • Absolute neutrophil count (ANC) ≥ 1500/mcL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN)
  • Total bilirubin ≤ 3 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Platelet count ≥ 100,000/mcL
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01511562

Contact: Tracy Batchelor, MD, MPH 617-643-1938

  Show 59 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Tracy Batchelor, MD, MPH Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01511562     History of Changes
Other Study ID Numbers: CALGB-51101, CALGB-51101, CDR0000721927
Study First Received: January 13, 2012
Last Updated: August 28, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administratioin

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Lymphoma, B-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Adjuvants, Immunologic
Alkylating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 09, 2015