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Chronic Lymphocytic LeukemiaPhase 1NCT02900716

Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas

A Phase 1 study testing DTRMWXHS-12, DTRM-505 and DTRM-555 in people with Chronic Lymphocytic Leukemia and B-Cell Lymphoma, run by Zhejiang DTRM Biopharma at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in combination. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia, B-Cell Lymphoma
What is being tested?
DTRMWXHS-12, DTRM-505 and DTRM-555
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesUnited States
Study dates
Sep 2016to 23 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of chronic lymphocytic leukemia (CLL) or other B-cell neoplasms including small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular B-cell non-Hodgkin's lymphoma (FL) who have no available approved therapies.
  • Age > 18 years.
  • Life expectancy greater than 12 weeks.
  • Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
  • Patients must provide written informed consent.
  • Ability to swallow and retain capsules.
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  • Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
  • Women of child-bearing potential must have a negative serum or urine pregnancy test.
  • Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
  • Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.

Who cannot join

  • Received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days or 5 half-lives for targeted therapies prior to this study entry.
  • Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptable
  • Pregnant or lactating individuals.
  • Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
  • AST or ALT > 2.5 x ULN
  • Total bilirubin > 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)
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  • Alkaline phosphatase > 2.5 x ULN
  • Glomerular filtration rate (GFR) < 50 mL/min, as assessed using the standard methodology at the investigating center (i.e. Cockroft-Gault), or serum creatinine > 1.5 x ULN
  • INR > 1.5 or other evidence of impaired hepatic synthesis function.
  • Persisting (> 8 weeks) severe pancytopenia due to hematologic disorder or due to previous therapy rather than disease (ANC < 0.5 x 109/L or platelets < 30 x 109/L) - to be confirmed via bone marrow biopsy, as part of normal clinical care, prior to signing of consent.
  • Previous allogeneic bone marrow transplant are restricted, unless there is no evidence of acute or chronic graft versus host disease.
  • CNS involvement with malignancy.
  • Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.
  • Known history of HIV, HBV or HCV infection.
  • Documented or known bleeding disorder.
  • Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low molecular weight heparin and heparin line flush allowed).
  • Patient is receiving any azole.
  • Patients with a significant cardiovascular disease or condition, including:
  • Myocardial infarction within 6 months of study entry
  • NYHA Class III or IV heart failure, or reduced LVEF <50%
  • Uncontrolled dysrhythmias or poorly controlled angina.
  • History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase Ia/Ib Study of a Novel BTK Inhibitor, DTRMWXHS-12, and Combination Products, DTRM-505 and DTRM-555, in Patients With Chronic Lymphocytic Leukemia or Other B-cell Lymphomas

This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in combination.

This study will be conducted in two parts: phase Ia and Ib. Both parts will explore escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy. The phase Ib study will evaluate DTRMWXHS-12 combinations.

Being tested
DTRMWXHS-12, DTRM-505, DTRM-555
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTRMWXHS-12Drug

    DTRMWXHS-12

  • DTRM-505Drug

    DTRMWXHS-12 and everolimus

  • DTRM-555Drug

    DTRMWXHS-12 and everolimus and pomalidomide

Study groups in NCT02900716
Study groupRoleWhat they receive
Phase IaExperimentalDTRMWXHS-12: oral capsules, daily x 21 days every 28 days
Receives: Drug: DTRMWXHS-12
Phase Ib, DTRM-505ExperimentalDTRMWXHS-12 oral capsules and everolimus oral tablets: daily x 21 days every 28 days
Receives: Drug: DTRM-505
Phase Ib, DTRM-555ExperimentalDTRMWXHS-12 and pomalidomide oral capsules, everolimus oral tablets: daily x 21 days every 28 days
Receives: Drug: DTRM-555

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Safety and tolerability

    Measured: Starting from date of first dose up to 30 days after last dose

Secondary outcomes (1)

  1. Plasma concentration over time

    Pharmacokinetics

    Measured: Days 1-28 (first treatment cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion23 Nov 2020
  4. Study completion23 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02900716
Sponsor's protocol ID
D15-11094
Status last verified
Apr 2020
First submitted
18 Aug 2016
Last updated
27 Nov 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DTRMWXHS-12, DTRM-505 and DTRM-555 in people with Chronic Lymphocytic Leukemia and B-Cell Lymphoma, run by Zhejiang DTRM Biopharma at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (time frame: Starting from date of first dose up to 30 days after last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02900716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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