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Trial · NCT05025800

ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma

NCT05025800, Phase 1, Phase 2, Active not recruiting, M.D. Anderson Cancer Center

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma. Trials, record NCT05025800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05025800

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
NCT number
NCT05025800
Status
Active not recruiting
Phases
Phase 1, Phase 2
Enrollment
47 participants, estimated
Lead sponsor
M.D. Anderson Cancer Center
Conditions
Aggressive B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma, Ann Arbor Stage III Grade 3 Follicular Lymphoma, Ann Arbor Stage III Marginal Zone Lymphoma, Ann Arbor Stage IV Grade 1 Follicular Lymphoma, Ann Arbor Stage IV Grade 2 Follicular Lymphoma, Ann Arbor Stage IV Grade 3 Follicular Lymphoma, Ann Arbor Stage IV Marginal Zone Lymphoma, Composite Lymphoma, Indolent B-Cell Non-Hodgkin Lymphoma, Refractory Aggressive B-Cell Non-Hodgkin Lymphoma, Refractory Follicular Lymphoma, Refractory Grade 3b Follicular Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Refractory Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, Richter Syndrome
Interventions
CD47 Antagonist ALX148, Lenalidomide, Rituximab
First posted
2021-08-27
Last updated
2026-09-18

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecommended phase II dose (RP2D) and schedule of ALX148 (Phase I)Up to 28 days
PrimaryComplete remission (CR) rate (Phase II)At 6 months
Response will be assessed by the investigator based on the 2014 Cheson Lugano criteria. The number and percentage of subjects with a CR at the end of treatment will be tabulated. The CR rate will be estimated with its exact 95% confidence interval (CI).
SecondaryOverall response rate (ORR) (CR + partial response [PR])After 6 cycles of treatment (At the end of Cycle 1 (each cycle is 28 days)
Will be assessed by the investigator based on Cheson, Lugano 2014. The number and percentage of subjects with an ORR will be tabulated. The best ORR will be recorded and summarized using exact method for 95% CI.
SecondaryDuration of responseFrom the time by which measurement criteria for CR or PR, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 yearsKaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
SecondaryProgression-free survival (PFS)From the date of cycle 1, day 1 (At the end of Cycle 1 (each cycle is 28 days)Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
SecondaryOverall survival (OS)From the date of cycle 1, day 1 (At the end of Cycle 1 (each cycle is 28 days)Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
SecondaryIncidence of treatment-emergent adverse events (AEs)Up to 30 days
Safety summaries will include tabulations in the form of tables and listings. The frequency (number and percentage) of treatment-emergent AEs will be reported. Additional AE summaries will include AE frequency by AE severity and by relationship to study drug. Clinically significant abnormal laboratory values will be summarized.
SecondaryIncidence of treatment-emergent AEs requiring temporary or permanent discontinuation of study drug or dose reductionsUp to 30 days
Safety summaries will include tabulations in the form of tables and listings. The frequency (number and percentage) of treatment-emergent AEs will be reported. Additional AE summaries will include AE frequency by AE severity and by relationship to study drug. Clinically significant abnormal laboratory values will be summarized.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39319495DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05025800

GET https://conductscience.org/api/trials/v1/NCT05025800/registered