Non-Hodgkin’s Lymphoma Clinical Trial

Summary

Clinical trials on Non Hodgkin’s Lymphoma (NLH) are also required to determine new therapeutic drugs and treatment options for patients. NHL clinical trials are required to acquire more information about the representativeness of patients included in clinical trials in order to judge the appropriateness of therapeutic protocols for NHL patients.

Clinical Trials

A clinical trial is a study performed in humans in order to evaluate medical, surgical, or behavioural interventions. Clinical trials are essential for researchers to determine whether a new treatment, a new drug, medical device or diet, is safe and effective in humans.

In other words, new treatments go through several phases in clinical trials. But, the cancer trials primarily include 4 phases. However, these trials are conducted for different purposes:

  • Initially, Phase 1 trials tests whether a new treatment is safe and finds out procedures to provide the treatment in the best possible way. Additionally, doctors also look for signs that cancer is responding to new treatments.
  • Later, For Phase 2, trials look at whether a particular cancer type is responding to the new treatment.
  • Subsequently, Phase 3 trials examine whether a new treatment works better than the conventional treatment.
  • Lastly, Phase 4 trials examine the detailed information on long-term side effects and benefits and on patients.

Need for NHL Clinical Trial

A majority of patients with Non-Hodgkin’s lymphoma (NHL) are older adults, with a median age at diagnosis of 66 years and 9.1% of patients over 85 years. However, the problem of the under-representation of older adults in cancer trials is well known. Undoubtedly, there is an increase in the number of older cancer patients. However, they remain under-represented in clinical trials. Moreover, clinical trials on NLH are also required to determine new therapeutic drugs and treatment options for patients. However, the NHL clinical trials must gather more information about the representativeness of patients enrolled in clinical trials in order to assess the appropriateness of therapeutic protocols for NHL patients​1​. Below mentioned are some NHL studies:

Name of the Clinical trialClinicalTrials.gov identifierPurpose of the Study
A Phase 1b/2 Open-label Study to Evaluate the Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapy in Subjects With Relapsed or Refractory Aggressive B-cell LymphomasNCT02271945To evaluate the tolerability, safety,  and clinical activity of MEDI-551/MEDI0680 (AMP-514) among patients with NHL​2​.
Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin’s LymphomaNCT00310128To determine the efficacy of combination chemotherapy with rituximab and yttrium Y90 ibritumomab tiuxetane in the treatment of patients with AIDS-related non-Hodgkin’s lymphoma related or refractory​3​.
Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™NCT03263026Approximately 235 patients with previously untreated high-risk large B-cell lymphoma (DLBCL) are expected to be included in this placebo-controlled randomized Phase 3 study. Subjects would be randomized R CHOP or 1:1  R-CHOP + enzastaurine or (+ during placebo induction)​4​.
A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination With Brentuximab Vedotin in Subjects With Relapsed Refractory Non Hodgkin Lymphomas With CD30 ExpressionNCT02581631The aim of this study was to determine whether brentuximab vedotin in combination with nivolumab is effective and safe in patients with certain NHL subtypes with CD30 expression who have not responded to treatment​5​.
A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCTNCT02038933The aim of this study was to determine whether nivolumab is effective for the treatment of DLBCL in patients ineligible or unsuccessful for ASCT​6​.
IELSG37: A Randomized, Open-label, Multicentre, Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)NCT01599559

The trial was designed according to a non-abnormality regimen that aims to demonstrate that survival without disease progression after experimental treatment (observation) is no worse than after standard comparison (mediastinal irradiation)​7​.

References

  1. 1.
    Bellera C, Praud D, Petit-Monéger A, McKelvie-Sebileau P, Soubeyran P, Mathoulin-Pélissier S. Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin’s lymphoma: a systematic review. Cancer Treat Rev. 2013;39(7):812-817. doi:10.1016/j.ctrv.2013.01.007
  2. 2.
    Goswami T, Canelos P, Parikh R. A Phase Ib/II open-label study to evaluate the safety and efficacy of MEDI-551 in combination with immunomodulating therapy in patients with relapsed or refractory aggressive B cell lymphomas. Journal for ImmunoTherapy of Cancer. 2014;2(3):1-2. doi:10.1186/2051-1426-2-S3-P73
  3. 3.
    Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin’s Lymphoma. Published online 2006. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT00310128
  4. 4.
    Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1TM. Published online 2017. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT03263026
  5. 5.
    A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination With Brentuximab Vedotin in Subjects With Relapsed Refractory Non Hodgkin Lymphomas With CD30 Expression. Published online 2015. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT02581631
  6. 6.
    A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT. Published online 2017. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT02038933
  7. 7.
    IELSG37: A Randomized, Open-label, Multicentre, Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL). Published online 2012. Accessed March 2022. https://clinicaltrials.gov/ct2/show/NCT01599559