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Alkylating agents

Chemo + Radiation for Nasal NK Cell Lymphoma

Phase 2
Recruiting
Led By Bouthaina Dabaja, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with newly diagnosed stage I and II nasal NK cell lymphoma
Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to disease progression or death due to disease, up to 5 years
Awards & highlights

Study Summary

This trial is studying if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma and the safety of the radiation and chemotherapy combination.

Who is the study for?
This trial is for adults with newly diagnosed stage I or II nasal NK cell lymphoma. Participants need normal blood counts, kidney and liver function, heart efficiency (ejection fraction ≥50%), and must not be pregnant or breastfeeding. They should agree to use contraception if of childbearing potential and have no active infections like Hepatitis B/C, HIV, severe heart conditions, or psychiatric issues that affect compliance.Check my eligibility
What is being tested?
The study tests the effectiveness of combining radiation therapy with chemotherapy drugs Etoposide phosphate, Ifosfamide, Carboplatin, Dexamethasone, and Mesna in controlling early-stage nasal NK cell lymphoma. The safety of this concurrent treatment approach is also being evaluated.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss; radiation may cause skin irritation at the site of treatment. There's a risk of lowered blood counts leading to infection or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with early-stage nasal NK cell lymphoma.
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I am using two forms of birth control or am not having sex to avoid pregnancy, or I cannot get pregnant due to menopause or surgery.
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My liver is functioning well, based on recent tests.
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I agree to use contraception or abstain from sex during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to disease progression or death due to disease, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to disease progression or death due to disease, up to 5 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 (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemotherapy + Radiation TherapyExperimental Treatment6 Interventions
Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles. DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide phosphate
1996
Completed Phase 2
~300
Ifosfamide
2010
Completed Phase 4
~2980
Carboplatin
2014
Completed Phase 3
~6670
Radiation Therapy
2017
Completed Phase 3
~7250
Dexamethasone
2007
Completed Phase 4
~2590
Mesna
2003
Completed Phase 2
~1380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
253 Trials studying Lymphoma
32,517 Patients Enrolled for Lymphoma
Bouthaina Dabaja, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
45 Total Patients Enrolled
2 Trials studying Lymphoma
5 Patients Enrolled for Lymphoma

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02106988 — Phase 2
Lymphoma Research Study Groups: Chemotherapy + Radiation Therapy
Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02106988 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02106988 — 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 applications is radiation therapy commonly utilized for?

"Radiation Therapy has demonstrated efficacy at treating synovitis, and is also commonly used to treat ophthalmia, sympathetic disorders, and prostate cancer."

Answered by AI

Are there any other precedents for using Radiation Therapy in medical research?

"As of now, 1427 clinical trials are ongoing that aim to evaluate the effectiveness and safety of Radiation Therapy. 395 studies have reached Phase 3 while 69353 research centres around the world are studying this therapy modality. Shanghai is a particularly popular destination with numerous sites involved in investigating Radiation Therapy."

Answered by AI

What is the current recruitment rate for this clinical trial?

"Affirmative. According to the data on clinicaltrials.gov, this medicinal trial is actively recruiting participants. This study was first posted on January 16th 2015 and last updated June 27th 2022 with a goal of forty patients from one medical facility."

Answered by AI

Are there still open slots available for enrolment in this experiment?

"Affirmative. According to clinicaltrials.gov, recruitment for the trial is still in progress since its initial posting on January 16th 2015 and most recent update on June 27th 2022. 40 volunteers are needed from a single research site."

Answered by AI

To what extent are people exposed to risks when undergoing Radiation Therapy?

"While there has been limited evidence of its efficacy, radiation therapy was assigned a safety rating of 2 as it had garnered some clinical data indicating that it is relatively safe."

Answered by AI
~21 spots leftby Jan 2034