Trial record 1 of 1 for:
NCT01511562
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.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01511562
First received: January 13, 2012
Last updated: February 2, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Lymphoma |
Drug: carmustine Drug: cytarabine Drug: etoposide Drug: thiotepa Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Two-year PFS [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 160 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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 on days -5 to -4. Beginning on day 4, patients also receive filgrastim subcutaneously (SC) until absolute neutrophil count recovers. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
|
Drug: carmustine
Given IV
Drug: thiotepa
Given IV
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous HSCT
Procedure: peripheral blood stem cell transplantation
Undergo autologous HSCT
|
|
Experimental: Arm II
Beginning at least 8 weeks and no later than 16 weeks after day 1 of induction course 5, patients receive cytarabine IV over 2 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 until absolute neutrophil count recovers.
|
Drug: cytarabine
Given IV
Drug: etoposide
Given IV
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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 or isolated leptomeningeal lymphoma
- At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length)
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years)
- Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted)
- 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)
- Negative human immunodeficiency virus (HIV) serology
- Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative)
- 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
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiation therapy for lymphoma
- No history of organ transplantation or ongoing immunosuppressant therapy
- No concurrent palliative radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511562
Locations
| United States, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Clinical Trials Office 617-724-5200 | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Tracy Batchelor, MD, MPH 617-643-1938 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Borgess Medical Center | Recruiting |
| Kalamazoo, Michigan, United States, 49001 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Raymond S. Lord, MD 269-373-7458 | |
| West Michigan Cancer Center | Recruiting |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Nina D. Wagner-Johnston 314-747-7222 | |
| United States, New York | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Joseph P. Lynch, MD 918-494-8275 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Maciej M. Mrugala 206-667-4692 | |
| Seattle Cancer Care Alliance | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Maciej M. Mrugala 206-598-4100 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Principal Investigator: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01511562 History of Changes |
| Other Study ID Numbers: | CDR0000721927, CALGB-51101 |
| Study First Received: | January 13, 2012 |
| Last Updated: | February 2, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Carmustine Thiotepa Etoposide phosphate Cytarabine Etoposide Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013