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NCT02529852

A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

Completed Phase 1, PHASE2 Results posted Last updated 19 September 2024
What this trial tests

Phase 1, PHASE2 trial testing Lenalidomide in Lymphoma in 59 participants. Completed in 31 October 2022.

Timeline
4 November 2015
Primary endpoint
31 October 2022
31 October 2022

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment59
Start date4 November 2015
Primary completion31 October 2022
Estimated completion31 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety of LO-CHOP Primary · up to 42 days

Assessing the participant's characteristics and clinical outcomes after 2 cycles/42 days of LO-CHOP. The safety evaluation is defined as the lack of any grade ≥3 nonhematologic toxicity unmanageable with aggressive supportive care or toxicity, resulting in a delay of over 7 days of cycle 2.

Grade 3 to 4 AE
GroupValue95% CI
Phase1b/Phase 270
DLTs
GroupValue95% CI
Phase1b/Phase 20
Overall Survival Secondary · up to 126 days

estimate overall survival

GroupValue95% CI
Phase1b/Phase 291.383.5 – 99.9
Progression Free Survival Secondary · up to 4.5 years

Progression free survival

GroupValue95% CI
Phase1b/Phase 287.478.4 – 97.5

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 4.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase1b/Phase2
Serious: 21/53 (40%)
Deaths: 4/53

Serious adverse events (11 terms)

ReactionSystemPhase1b/Phase2
NeutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
FatigueGeneral disorders
Febrile NeutropeniaBlood and lymphatic system disorders
InfectionInfections and infestations
PainGeneral disorders
NauseaGastrointestinal disorders
ConstipationGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
Peripheral sensory neuropathyNervous system disorders
DiarrheaGastrointestinal disorders
Other adverse events (12 terms — click to expand)

ReactionSystemPhase1b/Phase2
FatigueGeneral disorders
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
Peripheral sensory neuropathyNervous system disorders
NeutropeniaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
PainGeneral disorders
ThrombocytopeniaBlood and lymphatic system disorders
InfectionInfections and infestations
Febrile NeutropeniaBlood and lymphatic system disorders
Venous thromboembolismBlood and lymphatic system disorders

Most-reported serious reactions: Neutropenia, Thrombocytopenia, Fatigue, Febrile Neutropenia, Infection, Pain, Nausea, Constipation.

Data from ClinicalTrials.gov NCT02529852 adverse events section.

Sponsor's own description

There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma. The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Vincristine in Combination Therapy of Cancer: Emerging Trends in Clinics.
    Škubník J, Pavlíčková VS, Ruml T, Rimpelová S. · · 2021 · cited 86× · PMID 34571726 · DOI 10.3390/biology10090849
  2. A phase 1/2 study of lenalidomide and obinutuzumab with CHOP for newly diagnosed DLBCL.
    Cherng HJ, Alig SK, Oki Y, Nastoupil LJ, et al · · 2023 · cited 13× · PMID 36375046 · DOI 10.1182/bloodadvances.2022008174
  3. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma.
    Roschewski M, Kurtz DM, Westin JR, Lynch RC, et al · · 2025 · cited 10× · PMID 40802906 · DOI 10.1200/jco-25-01534

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02529852.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing