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DTRM-555 for Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

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.

Must not have

Central nervous system involvement with malignancy.

Documented or known bleeding disorder.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 and 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have a bleeding disorder.

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I need to take strong medication that affects how my body processes drugs.

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I have not had a heart attack in the last 6 months.

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I have severe heart failure.

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I do not have uncontrolled heart rhythm problems or severe chest pain.

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I have a history of serious irregular heartbeats or risk factors like heart failure.

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My diabetes is not well-managed despite medication.

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I do not have active HIV, HCV, or HBV, or if I do, my PCR test results are negative.

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I need blood thinners that affect my clotting tests.

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My heart's pumping ability is below 45%.

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My white blood cell and platelet counts are low, but not extremely low.

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My blood clotting time is longer than normal, indicating liver issues.

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My kidney function is reduced, with a filtration rate below 50 mL/min or creatinine levels above normal.

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My liver or kidney tests are not normal.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Responses (CR) and Partial Responses (PR) with DTRM-555 in the five disease-specific cohorts

Secondary study objectives

Overall Response Rate (ORR) with DTRM-555 in the five disease-specific cohorts

Plasma Exchange

Therapeutic procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 21Eligibility criteria met