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Alkylating agents
Chemotherapy + Stem Cell Transplant for Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70)
Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by brain biopsy or resection, cerebrospinal fluid, and vitreous fluid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial will compare two types of chemotherapy to see which is more effective in treating primary CNS B-cell lymphoma.
Who is the study for?
This trial is for adults aged 18-75 with primary CNS B-cell lymphoma, no history of other non-Hodgkin lymphomas or prior treatments. Participants must have a Karnofsky score indicating they can care for themselves and not be pregnant or nursing. They should test negative for HIV, hepatitis, and agree to use effective contraception.Check my eligibility
What is being tested?
The study compares the effects of chemotherapy alone versus chemotherapy followed by an autologous stem cell transplant in treating central nervous system B-cell lymphoma. The goal is to determine which treatment approach is more beneficial.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts; and those related to stem cell transplant like graft-versus-host disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly independent but may need assistance for some daily activities.
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My diagnosis of brain lymphoma was confirmed through a biopsy or fluid tests.
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I have not had chemotherapy or radiation for lymphoma.
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I am between 18 and 75 years old.
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My lymphoma is only in my brain or spinal cord, not elsewhere.
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I have never had an organ transplant or been on ongoing immunosuppressant therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression free survival
Secondary outcome measures
event free survival
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
overall survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm IIExperimental Treatment3 Interventions
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
Group II: Arm IExperimental Treatment4 Interventions
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
stem cell transplant
2009
Completed Phase 2
~50
Etoposide
FDA approved
Thiotepa
FDA approved
Carmustine
FDA approved
Filgrastim
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,251 Total Patients Enrolled
1,392 Trials studying Lymphoma
382,349 Patients Enrolled for Lymphoma
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,513 Total Patients Enrolled
54 Trials studying Lymphoma
7,490 Patients Enrolled for Lymphoma
Tracy Batchelor, MD, MPHStudy ChairMassachusetts General Hospital
4 Previous Clinical Trials
435 Total Patients Enrolled
2 Trials studying Lymphoma
12 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly independent but may need assistance for some daily activities.My diagnosis of brain lymphoma was confirmed through a biopsy or fluid tests.I have not had chemotherapy or radiation for lymphoma.I am between 18 and 75 years old.I do not have hepatitis C, and if I had hepatitis B, it's under control or being monitored.I am not pregnant or nursing and will use effective birth control during the study.My lymphoma is only in my brain or spinal cord, not elsewhere.I have never had an organ transplant or been on ongoing immunosuppressant therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II
- Group 2: Arm I
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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