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LAM-002A for Non-Hodgkin's Lymphoma (LAM-002A/NHL Trial)

Phase 1

Waitlist Available

Research Sponsored by OrphAI Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 cycle (28 days) to 6 or more cycles

Awards & highlights

LAM-002A/NHL Trial Summary

This trial is testing a new drug, LAM-002A, to see if it is safe and works well against B-cell NHL.

Eligible Conditions

Non-Hodgkin Lymphoma

LAM-002A/NHL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 cycle (28 days) to 6 or more cycles

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 cycle (28 days) to 6 or more cycles

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 cycle (28 days) to 6 or more cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the MTD of oral LAM-002A

Secondary outcome measures

Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria

Area under the plasma concentration versus time curve (AUC) of LAM-002A

Peak Plasma Concentration (Cmax) of LAM-002A

+1 more

Other outcome measures

Evaluation of genetic alterations and expression in tumor

Evaluation of immune modulatory effects of LAM-002A

Microscopic changes in the internal structure of tumor cells and white blood cells

+1 more

LAM-002A/NHL Trial Design

4Treatment groups

Experimental Treatment

Group I: LAM-002A + rituximabExperimental Treatment1 Intervention

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)

Group II: LAM-002A + atezolizumabExperimental Treatment1 Intervention

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

Group III: Intermittent monotherapyExperimental Treatment1 Intervention

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.

Group IV: Continuous monotherapyExperimental Treatment1 Intervention

All patients will take LAM-002A two times daily by mouth every day until cancer progression or intolerability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LAM-002A

2015

Completed Phase 1

~70

Rituximab

1999

Completed Phase 4

~1880

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OrphAI TherapeuticsLead Sponsor

6 Previous Clinical Trials

214 Total Patients Enrolled

AI Therapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

214 Total Patients Enrolled

Langdon Miller, MDStudy DirectorAI Therapeutics

2 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents for the deployment of LAM-002A in a clinical setting?

"Initially investigated at the National Institutes of Health Clinical Center in 1993, LAM-002A has since been trialled 884 times. Of these studies, 753 are still active and a number of them take place in Lafayette, Indiana."

Answered by AI

Are there still openings available for participants in this clinical investigation?

"Unfortunately, the information on clinicialtrials.gov indicates that this trial is not actively recruiting patients anymore; though it was first posted back in October 1st 2015 and last modified on May 2nd 2022. Nevertheless, there are 2641 other trials currently looking for participants."

Answered by AI

Could you elucidate the safety profiles of LAM-002A?

"The safety of LAM-002A is rated at 1 since it has yet to pass through the preclinical phases and there exists limited evidence for its efficacy."

Answered by AI

Is there a limitation to the number of persons involved in this scientific experiment?

"At present, this clinical trial is not taking on any additional participants. It was initially posted in October 2015 and last updated on May 2nd 2022. If you're looking for alternative studies, there are 1888 trials currently seeking patients with diffuse lymphoma and 753 actively recruiting for LAM-002A."

Answered by AI

What is the scope of this clinical investigation in terms of medical sites?

"Currently, 11 medical centres are recruiting patients for this trial. These clinics can be found in Lafayette, Rochester and Boston amongst other places - picking the one nearest to you is a great way to reduce travel requirements if participating."

Answered by AI

In what clinical scenarios is LAM-002A employed?

"LAM-002A is generally prescribed to treat pharmacotherapy, yet it can also alleviate symptoms of diffuse large b-cell lymphoma (dlbcl), small cell lung cancer (sclc) and other varieties of B-Cell Lymphomas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (LAM-002A/NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02594384.