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NCT01919619

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies

Completed Phase 2 Results posted Last updated 3 December 2024
What this trial tests

Phase 2 trial testing Ipilimumab in B-Cell Non-Hodgkin Lymphoma in 41 participants. Completed in 3 May 2024.

Timeline
4 November 2013
Primary endpoint
3 May 2024
3 May 2024

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment41
Start date4 November 2013
Primary completion3 May 2024
Estimated completion3 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 80, any sex, with B-Cell Non-Hodgkin Lymphoma or Hematopoietic and Lymphoid Cell Neoplasm. 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.

Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant Primary · Up to 30 days following the last dose of study drugs

Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.

GroupValue95% CI
Autologous -Treatment (Lenalidomide and Ipilimumab)10
Allogeneic - Treatment (Lenalidomide and Ipilimumab)2
Number of Participants Achieved Complete Remission Secondary · Up to 30 days following the last dose of study drug

CR is defined as a complete resolution of all target lesions by CT scans with complete normalization of FDG-PET uptake in all areas, and bone marrow biopsy negativity.

GroupValue95% CI
Autologous -Treatment (Lenalidomide and Ipilimumab)22
Allogeneic - Treatment (Lenalidomide and Ipilimumab)5
Progression-free Survival Secondary · Up to 36 months

Number of participants that are alive and disease free 36 months long post transplant

GroupValue95% CI
Autologous -Treatment (Lenalidomide and Ipilimumab)18
Allogeneic - Treatment (Lenalidomide and Ipilimumab)4

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Autologous -Treatment (Lenalidomide and Ipilimumab)
Serious: 10/28 (36%)
Deaths: 7/28
Allogeneic - Treatment (Lenalidomide and Ipilimumab)
Serious: 2/13 (15%)
Deaths: 5/13

Serious adverse events (3 terms)

ReactionSystemAutologous -Treatment (Len…Allogeneic - Treatment (Le…
Low granulocyteBlood and lymphatic system disorders
Low plateletInvestigations
ViralInfections and infestations
Other adverse events (64 terms — click to expand)

ReactionSystemAutologous -Treatment (Len…Allogeneic - Treatment (Le…
Low plateletInvestigations
AnemiaInvestigations
Low granulocyteBlood and lymphatic system disorders
Wbc decreasedInvestigations
DiarrheaGastrointestinal disorders
ALT increasedInvestigations
AST increasedInvestigations
ALK increasedInvestigations
RashSkin and subcutaneous tissue disorders
OtherGeneral disorders
FatigueGeneral disorders
Creatinine increasedInvestigations
NauseaGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
LDH increasedInvestigations
Flu like syndromeGeneral disorders
Oral mucositisGastrointestinal disorders
Fluid overloadGeneral disorders
NE OTHNervous system disorders
T bilirubin increasedInvestigations
ViralInfections and infestations
DizzinessNervous system disorders
EN OTHEndocrine disorders
FeverGeneral disorders
GI OTHGastrointestinal disorders
HyperglycemiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
IN FECInfections and infestations
Nasal congestionRespiratory, thoracic and mediastinal disorders
Abdominal distensionGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Blurred visionEye disorders
BacterialInfections and infestations
Blurred visionEye disorders
ConstipationGastrointestinal disorders
DysrhythmiaCardiac disorders
EdemaGeneral disorders
HeadacheNervous system disorders
HypocalcemiaMetabolism and nutrition disorders

Most-reported serious reactions: Low granulocyte, Low platelet, Viral.

Data from ClinicalTrials.gov NCT01919619 adverse events section.

Sponsor's own description

This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies.

Publications & conference data

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

  1. Targeting the Immune Microenvironment in Acute Myeloid Leukemia: A Focus on T Cell Immunity.
    Lamble AJ, Lind EF. · · 2018 · cited 95× · PMID 29951373 · DOI 10.3389/fonc.2018.00213
  2. Trial Watch: Immunostimulatory monoclonal antibodies in cancer therapy.
    Aranda F, Vacchelli E, Eggermont A, Galon J, et al · · 2014 · cited 92× · PMID 24701370 · DOI 10.4161/onci.27297
  3. Trial Watch: Immunomodulatory monoclonal antibodies for oncological indications.
    Buqué A, Bloy N, Aranda F, Castoldi F, et al · · 2015 · cited 79× · PMID 26137403 · DOI 10.1080/2162402x.2015.1008814
  4. Immune cell constitution in bone marrow microenvironment predicts outcome in adult ALL.
    Hohtari H, Brück O, Blom S, Turkki R, et al · · 2019 · cited 60× · PMID 30635636 · DOI 10.1038/s41375-018-0360-1
  5. Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.
    Griggio V, Perutelli F, Salvetti C, Boccellato E, et al · · 2020 · cited 54× · PMID 33312177 · DOI 10.3389/fimmu.2020.594556
  6. Immune checkpoint blockade for hematologic malignancies: a review.
    Pianko MJ, Liu Y, Bagchi S, Lesokhin AM. · · 2017 · cited 48× · PMID 28529947 · DOI 10.21037/sci.2017.03.04
  7. Checkpoint Inhibitors and Other Immune Therapies for Hodgkin and Non-Hodgkin Lymphoma.
    Matsuki E, Younes A. · · 2016 · cited 40× · PMID 27193488 · DOI 10.1007/s11864-016-0401-9
  8. Immune-Checkpoint Inhibitors in B-Cell Lymphoma.
    Armengol M, Santos JC, Fernández-Serrano M, Profitós-Pelejà N, et al · · 2021 · cited 38× · PMID 33430146 · DOI 10.3390/cancers13020214

Verify or expand the search:

Other trials of Ipilimumab

Trials testing the same drug.

Other recruiting trials for B-Cell Non-Hodgkin Lymphoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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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/NCT01919619.

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