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Histone Deacetylase Inhibitor

Gemcitabine Hydrochloride for Non-Hodgkin's Lymphoma

Phase 1
Waitlist Available
Led By Grzegorz S. Nowakowski, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial is testing the side effects of directly injecting drugs into tumors and using FDG-PET to see which drugs are most effective in treating non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Breast Cancer
  • Hodgkin's Lymphoma
  • Mycosis Fungoides
  • Cutaneous T-Cell Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Non-Hodgkin's Lymphoma
  • Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anniversary Reaction
Secondary outcome measures
Cutaneous response rate based upon the modified Severity Weighted Assessment Tool score
Feasibility
Incidence of adverse events
+1 more
Other outcome measures
Apoptosis in response to intratumoral injection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (FDG-PET, direct tumor microinjection)Experimental Treatment15 Interventions
Patients undergo FDG-PET and receive saline intralesionally on day 1. Patients also receive up to five additional injections of gemcitabine hydrochloride, romidepsin, belinostat, carfilzomib, copanlisib hydrochloride, nivolumab, trastuzumab, daratumumab, obinutuzumab, pembrolizumab, or rituximab intralesionally per investigator on day 1. Beginning 5 days later, patients with nodal/extranodal mass undergo restaging FDG-PET and biopsy (if clinically feasible). Within 3-7 days, patients with cutaneous disease undergo restaging photography and biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Positron Emission Tomography
2008
Completed Phase 2
~2240
Trastuzumab
2014
Completed Phase 4
~5190
Daratumumab
2014
Completed Phase 3
~1860
Nivolumab
2014
Completed Phase 3
~4750
Obinutuzumab
2015
Completed Phase 3
~3250
Belinostat
2006
Completed Phase 2
~430
Carfilzomib
2017
Completed Phase 3
~1440
Fludeoxyglucose F-18
2018
Completed Phase 2
~550
Pembrolizumab
2017
Completed Phase 2
~2010
Rituximab
1999
Completed Phase 4
~1880
Romidepsin
2011
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,745 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,114 Total Patients Enrolled
Grzegorz S. Nowakowski, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
138 Total Patients Enrolled

Frequently Asked Questions

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

Is there any prior research involving Gemcitabine Hydrochloride?

"At present, 2884 clinical trials are being conducted to investigate the effects of Gemcitabine Hydrochloride. 501 of these studies have entered Phase 3 and Seattle, Washington is one hub for this research with 126633 other locations running similar experiments globally."

Answered by AI

What sort of sample size is included in this medical research?

"Affirmative. The clinical trial's record on clinicaltrials.gov confirms that, since its first posting of March 27th 2018, the study is still searching for volunteers. 39 participants must be enrolled from just one medical centre."

Answered by AI

Are there any vacancies left in this clinical trial?

"Clinicaltrials.gov confirms that this medical trial is actively in search of participants. It was initially posted on March 27th 2018 and has recently been updated with the last edit being made on December 14 2021."

Answered by AI

In what healthcare scenarios is Gemcitabine Hydrochloride typically employed?

"Gemcitabine Hydrochloride is a medically accepted treatment procedure for refractory and relapsed Mediastinal large B-Cell lymphoma as well as Small cell lung cancer (SCLC)."

Answered by AI

Is Gemcitabine Hydrochloride a viable option for healthcare consumers?

"With minimal data available to evaluate its safety and effectiveness, Gemcitabine Hydrochloride scored a 1 on our team's assessment scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
2018. "Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03432741.
~5 spots leftby Apr 2025
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