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DTRM-555 for Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Research Sponsored by Zhejiang DTRM Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a diagnosis of R/R CLL or other B-cell neoplasms (i.e., ABC DLBCL, GCB DLBCL, Richter's transformation and tFL) who have no available approved therapies, or patients with a diagnosis of non-Hodgkin's lymphoma, which has relapsed and/or is refractory to standard therapy.
Ability to swallow and retain capsules and/or tablets.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12 and 24 months
Awards & highlights
Study Summary
This trial will evaluate a new oral combination of targeted drugs, called DTRM-555, for patients with relapsed or refractory chronic lymphocytic leukemia or non-Hodgkin's lymphoma.
Who is the study for?
This trial is for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or non-Hodgkin's lymphoma who've had certain previous treatments but not specific mutations. They must be able to swallow pills, have a life expectancy over 12 weeks, and an ECOG status of 0-1. Women must test negative for pregnancy and use contraception; men must use condoms.Check my eligibility
What is being tested?
The study tests DTRM-555, a novel oral combination therapy for patients with R/R CLL or R/R non-Hodgkin's lymphoma. It aims to improve upon single drug therapies by using a triple combination approach to see if it's more effective.See study design
What are the potential side effects?
While the side effects of DTRM-555 are not explicitly listed here, similar cancer therapies often include fatigue, nausea, diarrhea, liver issues, increased risk of infection, bleeding complications and potential heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of B-cell cancer or non-Hodgkin's lymphoma that hasn't responded to standard treatments.
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I can swallow and keep down pills.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have any uncontrolled illnesses or infections.
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I am 18 years old or older.
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I agree to use a condom during the study and for 4 weeks after, even though I've had a vasectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Responses (CR) and Partial Responses (PR) with DTRM-555 in the five disease-specific cohorts
Secondary outcome measures
Overall Response Rate (ORR) with DTRM-555 in the five disease-specific cohorts
Plasma Exchange
Therapeutic procedure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Disease-specific cohortsExperimental Treatment1 Intervention
Participants will be administered the oral triple-combination therapy, DTRM-555 (comprised of 200mg of DTRMWXHS-12, 5mg of everolimus and 2mg of pomalidomide), once-daily for 21 consecutive days every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DTRM-555
2016
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Zhejiang DTRM BiopharmaLead Sponsor
3 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have CLL and was treated with BTK or BCL2 inhibitors but don't have the Cys481 mutation.I agree to use a condom during the study and for 4 weeks after, even though I've had a vasectomy.My kidney function is reduced, with a filtration rate below 50 mL/min or creatinine levels above normal.I have no other cancers, except possibly treated skin cancer or cervical cancer with no signs for 2+ years.My cancer has spread to my brain or spinal cord.My diabetes is not well-managed despite medication.I do not have active HIV, HCV, or HBV, or if I do, my PCR test results are negative.I need blood thinners that affect my clotting tests.My heart's pumping ability is below 45%.I agree to a safe tumor biopsy or can provide recent tissue samples.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any uncontrolled illnesses or infections.I have a bleeding disorder.I do not have any active infections needing treatment.I have a history of serious irregular heartbeats or risk factors like heart failure.I have severe heart failure.I have a type of B-cell cancer or non-Hodgkin's lymphoma that hasn't responded to standard treatments.I haven't had chemotherapy, immunotherapy, radiotherapy, or any experimental treatments in the last 21 days.My white blood cell and platelet counts are low, but not extremely low.I've had cancer treatment recently.I haven't taken any targeted cancer drugs recently.I am 18 years old or older.My liver or kidney tests are not normal.I have at least one measurable lesion, unless I have relapsed or refractory CLL.I have not had a heart attack in the last 6 months.I had a bone marrow transplant over 3 months ago and do not have graft versus host disease.My blood clotting time is longer than normal, indicating liver issues.I need to take strong medication that affects how my body processes drugs.I am capable of becoming pregnant and have a negative pregnancy test.I can swallow and keep down pills.I do not have serious heart problems.I do not have uncontrolled heart rhythm problems or severe chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: Disease-specific cohorts
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior research efforts have been made with respect to DTRM-555?
"Currently, there are 179 experiments being conducted for DTRM-555. 26 of these trials are in the late stages, Phase 3. Although most studies take place in Hamilton, Ontario, 6803 other clinical sites across the world have also taken part in researching this new treatment option."
Answered by AI
How many individuals have joined the trial thus far?
"Affirmative. Data from clinicaltrials.gov confirms that this research endeavour, initially posted on April 24th 2020, is actively recruiting volunteers. 120 individuals need to be sourced from 8 separate institutions."
Answered by AI
What potential hazards should be taken into account when handling DTRM-555?
"Despite the absence of clinical data backing its efficacy, our team at Power have evaluated DTRM-555 to be moderately safe with a score of 2."
Answered by AI
What ailments has DTRM-555 been clinically proven to help mitigate?
"DTRM-555 is a commonly utilized remedy for dealing with kidney transplant rejection. Additionally, this medication may be of benefit to those suffering from waldenstrom macroglobulinemia, lung issues, and advanced carcinoid tumor."
Answered by AI
Are recruiting efforts underway to include participants in this trial?
"Affirmative. Clinicaltrials.gov confirms that enrollment for this clinical trial is open, with the original post dating back to April 24th 2020 and last updated on April 28th 2022. The research team is looking for 120 individuals across 8 medical centres."
Answered by AI
How many sites are actively engaged in managing this research endeavor?
"This trial is recruiting subjects at institutions such as University of Pennsylvania Abramson Cancer Center in Philadelphia, Duke Cancer Institute in Durham, and Memorial Sloan Kettering Cancer Centre in New york. In addition to these three sites, there are 8 additional locations taking part in the study."
Answered by AI
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