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New treatment option for LGLL - Large Granular Lymphocytic Leukemia
Official title A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
ClinicalTrials.gov ID: NCT05475925
What this study is testing
What is DR-01?
DR-01 is an investigational medicine, being studied as a potential treatment for lgll - large granular lymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (All people):
- ≥18 years of age.
- Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
- Sufficient key organ performance and coagulation.
- Female people of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \<1 year postmenopausal) must agree to...
You likely can't join if
- Disease-specific Exclusion Criteria; LGLL and ANKL:
- A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The...
- Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
- Active or suspected malignant central nervous system involvement.
- Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular...
- Active known second malignancy.
See the full eligibility criteria
- (All people):
- ≥18 years of age.
- Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
- Sufficient key organ performance and coagulation.
- Female people of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \<1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through...
- Male people must agree to use acceptable effective method(s) of contraception. people with LGLL must also meet 6 and 7.
- Must have discontinued at least one prior line of systemic therapy.
- Additional immunophenotypic and symptomatic criteria must be met. Disease-specific (Cytotoxic Lymphomas): people with cytotoxic lymphomas must also meet 8,9, and 10.
- people must have failed at least one prior systemic regimens.
- Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.
- Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification [Swerdlow 2016]).
- For Part A only, evaluable disease is acceptable.
- For Part B2 only, evaluable by the following response criteria as documented during Screening:
- For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - people must have radiographically measurable disease by computed tomography (CT) or CT/positron emission tomography (PET) scan defined as at least one node measuring...
- For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - people with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that...
- For HSTCL, ANKL, SysEBV TCL - people with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a...
- Disease-specific Exclusion Criteria; LGLL and ANKL:
- A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The following exclusion criteria apply to all people:
- Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
- Active or suspected malignant central nervous system involvement.
- Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
- Active known second malignancy.
- Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
- Hepatitis B infection (hepatitis B virus surface antigen [HBsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). people with HCV with undetectable virus after...
- History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
- Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological...
- Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
- Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.
- Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting inclusion criteria).
- Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
- Any immunosuppressive therapy for GVHD for people who are post allogeneic HSCT.
- Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Irvine, California, United States
- Redwood City, California, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Clayton, Victoria, Australia
- Richmond, Victoria, Australia
- Nedlands, Washington, Australia
- Pierre-Bénite, France
- Rennes, France
- Toulouse, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Irvine, California, United States; Redwood City, California, United States; New Haven, Connecticut, United States; Tampa, Florida, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.