A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (LAM-002A/NHL)



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:October 2015
End Date:December 2019
Contact:Henri Lichenstein, PhD
Email:hlichens@ai-thera.com
Phone:2034587100

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A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A (Apilimod Dimesylate Capsules) Administered Orally in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with
relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.

LAM-002A is supplied as 25-mg or 50-mg capsules and will be administered two times daily or
three times daily by mouth in repeated 28-day cycles. Patients will be advised to take the
doses at the same time each day.

A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The MTD is defined
as the highest dose at which no more than 1 of 6 patients (i.e., < 33%) experiences a
dose-limiting toxicity (DLT) in the dose cohort.

Once the dose and schedule are established, additional patients will be treated to better
characterize the safety, tolerability,PK, PD, and anti-tumor activity of LAM-002A when
administered alone or in combination with rituximab or atezolizumab.

Inclusion Criteria:

1. Able to understand and comply with the protocol requirements and has signed the
informed consent document.

2. Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma
(FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone
lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) that has progressed and for which
standard curative measures do not exist or are no longer effective. Prior therapy must
have included a rituximab-based regimen.

3. Patients with DLBCL: Cancer progression after transplant, or be unwilling, unable or
not an appropriate candidate for an autologous stem cell or bone marrow transplant

4. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of 1 or more lesions that measure at least 2.0 cm in the longest
dimension (as assessed radiographically)

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.

6. Adequate organ and marrow function.

7. Able to swallow oral capsules without difficulty.

8. Acceptable birth control.

9. Women of childbearing potential : negative pregnancy test

10. Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral
blood) for analysis of potential predictive biomarkers.

Exclusion Criteria:

1. Patients with central nervous system (CNS) lymphoma are not eligible for the trial
unless the disease had been treated and the subject remains without symptoms with no
active CNS lymphoma.

2. Not recovered from toxicity due to all prior therapies.

3. Other uncontrolled significant illness.

4. History of malabsorption or other gastrointestinal (GI) disease that may significantly
alter the absorption of LAM-002A

5. Major surgery within 28 days prior to first dose of study drug.

6. Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency
virus (HIV), hepatitis B or hepatitis C.

7. Lactation or breast feeding.

8. Unable or unwilling to abide by the study protocol or cooperate fully with the
Investigator or designee.

This is a shortened list and additional criteria may apply.
We found this trial at
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Loretta Nastoupil, MD
Phone: 713-792-1044
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jeremy Abramson, MD
Phone: 617-643-9607
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Taimur Sher, MD
Phone: 904-953-7563
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Jonathan Cohen, MD
Phone: 404-778-4449
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Dipti Patel-Donnelly, MD
Phone: 703-208-3192
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Huntsville, Alabama 35805
Principal Investigator: Marshall Schreeder, MD
Phone: 256-705-4283
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Lafayette, Indiana
Principal Investigator: Wael A Harb, MD
Phone: 765-446-5111
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New York, New York 10021
Principal Investigator: Sarah Rutherford, MD
Phone: 646-962-8232
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Catherine Diefenbach, MD
Phone: 646-501-7920
New York University School of Medicine NYU School of Medicine has a proud history that...
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Rochester, Minnesota 55905
Principal Investigator: Stephen Ansell, MD
Phone: 507-266-3784
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: David Aboulafia, MD
Phone: 206-287-5671
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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