A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (LAM-002A/NHL) (LAM-002A/NHL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02594384 |
Recruitment Status :
Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : May 3, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic | Drug: LAM-002A Drug: Rituximab Drug: Atezolizumab | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | March 9, 2020 |
Estimated Study Completion Date : | March 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Continuous monotherapy
All patients will take LAM-002A two times daily by mouth every day until cancer progression or intolerability.
|
Drug: LAM-002A
25 mg capsules or 50 mg capsules
Other Name: apilimod dimesylate |
Experimental: Intermittent monotherapy
All patients will receive LAM-002A at escalating dose levels two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability.
|
Drug: LAM-002A
25 mg capsules or 50 mg capsules
Other Name: apilimod dimesylate |
Experimental: LAM-002A + rituximab
All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab 375 mg/m2 by vein every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions)
|
Drug: Rituximab
375 mg/m2 by vein
Other Name: rituxan |
Experimental: LAM-002A + atezolizumab
All patients will receive LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability
|
Drug: Atezolizumab
1200 mg by vein
Other Name: Tecentriq |
- Determination of the MTD of oral LAM-002A [ Time Frame: 28 days ]Dose escalation until determination of DLTs
- Peak Plasma Concentration (Cmax) of LAM-002A [ Time Frame: 28 days ]Evaluation of LAM-002A and its metabolites in plasma
- Area under the plasma concentration versus time curve (AUC) of LAM-002A [ Time Frame: 28 days ]Evaluation of LAM-002A and its metabolites in plasma
- Type and frequency of adverse events and serious adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 cycle (28 days) to 6 or more cycles ]Identify toxicities
- Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria [ Time Frame: 1 cycle (28 days) to 6 or more cycles ]Evaluation of the ability of LAM-002A to shrink tumors
- Microscopic changes in the internal structure of tumor cells and white blood cells [ Time Frame: 1 cycle (28 days) to 2 cycles ]Determine the effect of LAM-002A on tumor cells and blood samples
- Evaluation of genetic alterations and expression in tumor [ Time Frame: 1 cycle (28 Days) to 2 cycles ]Determine potential genetic make-up of NHL tumors
- Evaluation of immune modulatory effects of LAM-002A [ Time Frame: 1 cycle (28 days) to 2 cycles ]Determine immune modulation activity of LAM-002A
- Plasma identification of analytes [ Time Frame: 1 cycle (28 days) ]Preliminary assessment of anti-lymphoma activity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to understand and comply with the protocol requirements and has signed the informed consent document.
- 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.
- 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
- 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)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
- Adequate organ and marrow function.
- Able to swallow oral capsules without difficulty.
- Acceptable birth control.
- Women of childbearing potential : negative pregnancy test
- Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.
Exclusion Criteria:
- 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.
- Not recovered from toxicity due to all prior therapies.
- Other uncontrolled significant illness.
- History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of LAM-002A
- Major surgery within 28 days prior to first dose of study drug.
- Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Lactation or breast feeding.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594384
United States, Alabama | |
Clearview Cancer Institute | |
Huntsville, Alabama, United States, 35805 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Georgia | |
Winship Cancer Institute at Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Indiana | |
Horizon Oncology Research, Inc. | |
Lafayette, Indiana, United States, 47905 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
Weill Cornell Medical College | |
New York, New York, United States, 10021 | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Study Director: | Langdon Miller, MD | AI Therapeutics |
Responsible Party: | AI Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02594384 |
Other Study ID Numbers: |
LAM-002A-NHL-CLN01 |
First Posted: | November 3, 2015 Key Record Dates |
Last Update Posted: | May 3, 2022 |
Last Verified: | May 2022 |
Phase 1 Safety Apilimod dimesylate |
Pharmacokinetics Non-Hodgkin Lymphoma Chronic lymphocytic leukemia |
Lymphoma Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia |
Leukemia, B-Cell Leukemia, Lymphoid Rituximab Atezolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |