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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

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
13,609 Previous Clinical Trials
40,915,533 Total Patients Enrolled
1,376 Trials studying Lymphoma
381,471 Patients Enrolled for Lymphoma
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,521 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

Carmustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01511562 — Phase 2
Lymphoma Research Study Groups: Arm II, Arm I
Lymphoma Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT01511562 — Phase 2
Carmustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01511562 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues is this remedy typically utilized for?

"Acute lymphoblastic leukemia (ALL) can often be treated with this pharmaceutical intervention. Additionally, glioblastoma, brain stem gliomas and non-Hodgkin's Lymphoma are all ailments that may benefit from the same treatment."

Answered by AI

What is the cap on enrollment for this experiment?

"This particular clinical trial has concluded its recruitment phase. Initially posted on September 1st 2012, the last update was made August 16th 2021. Nevertheless, there are still 1717 medical trials accepting lymphoma patients and 612 studies recruiting for this medication that remain open to new participants."

Answered by AI

Are there any openings for participation in this experiment?

"Sadly, no more participants are being accepted for this trial. It was first posted on September 1st 2012 and the latest update occured on August 16th 2021. If you're seeking out other trials relating to lymphoma, there currently exist 1717 open studies with 612 recruiting patients for that intervention."

Answered by AI

Is enrollment for this research project still open?

"An enrolment of 113 participants has been approved for this medical trial, all aged between 18 and 75. To qualify, patients must have no prior chemotherapy or radiation therapy for lymphoma as well as a confirmed diagnosis from either brain biopsy/resection or cerebrospinal fluid/vitreous fluid; be negative for HIV serology and HCV serology (unless HBsAb positive patient has recently received HBV vaccine); measure Karnofsky Performance Scale ≥ 30 (≥ 50 for those ages 60-70) and possess an ANC ≥ 1500/mcL with AST & ALT < 2 x upper limit of normal"

Answered by AI

Does this study accept applicants aged 70 and above?

"As per the listed inclusion criteria, this study is suitable for individuals between ages 18 and 75. There are 536 clinical trials geared towards minors under 18 years old and 1960 studies that cater to elderly adults over 65."

Answered by AI

Has there been any past research conducted on this particular remedy?

"In 1997, City of Hope Comprehensive Cancer Center initiated the first clinical trial with this particular medication. Since then, 1138 studies have been completed while 612 are still ongoing - notably, a significant number are being conducted in Walla Walla, Washington."

Answered by AI

Is there a multiple-site deployment of this study in Canada?

"The present medical trial is operating out of an extensive network of 100 sites; these include the cities Walla Walla, Franklin and Kettering. To reduce any potential travel burden, it is advised that participants choose their nearest clinical centre."

Answered by AI

Has this remedial protocol been sanctioned by the FDA?

"Despite the lack of clinical evidence that this treatment is effective, there are some safety data points available. Consequently, our team at Power assigned a rating of 2 to its safety profile."

Answered by AI
~20 spots leftby Oct 2026