New Clinical Trial: Phase 3 Study of Ibrutinib in Combination with Either Bendamustine and Rituximab or R-CHOP in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular and marginal zone lymphoma. The study sponsor is Janssen Research & Development LLC., and the principal investigator at Weill Cornell is Peter Martin, M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Open to men and women age 18 and older.
  • Follicular or Marginal Zone, non-Hodgkin lymphoma.
  • Relapsed or Refractory after receiving at least one prior chemotherapy regimen.
  • At least one site of measurable disease.
  • Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with follicular or marginal zone lymphoma who have been previously treated.

The purpose of this study is to compare whether adding ibrutinib to the standard chemotherapy options for this population bendamustine/rituximab (BR) or R-CHOP result in a longer progression-free survival than BR or R-CHOP alone.

The type of chemotherapy received will be dependent on refractory versus relapsed disease, type of indolent non-Hodgkin lymphoma, and number of prior lines of therapy.

All participants will be randomized in a one to one ratio to receive the study drug, ibrutinib, or placebo.

Randomization arms: This study is comparing BR or R-CHOP in combination with ibrutinib or placebo. This is a double blind study so neither the patient or the physician will know if you’re receiving the study medication, ibrutinib or placebo. Placebo is a blank pill that will look similar to ibrutinib but contains no medicine. The physicians will decide whether patients will receive BR or R-CHOP chemotherapy depending on prior treatments.

Patients will receive the standard 6 cycles of BR or R-CHOP and will continue taking ibrutinib or placebo as long as they are responding to therapy and not experiencing unacceptable side effects.

New Clinical Trial: Phase 2 Study of High Dose Chemotherapy with Autologous Stem Cell Transplant followed by Maintenance Therapy with Romidepsin for the Treatment of T-cell Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with T-cell lymphoma. The study sponsor is Memorial Sloan Kettering Cancer Center, and the principal investigator at Weill Cornell is Jia Ruan, M.D., Ph.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 16 and older.
  • T-cell non-Hodgkin lymphoma (NHL).
  • Complete or partial response to prior therapy.
  • Eligible for stem cell transplant.
  • No prior autologous or allogenic transplant.

Study Details

This clinical trial is for men and women with T-cell non-Hodgkin lymphoma. The purpose of the study is to test the benefit of a chemotherapy drug called romidepsin in men and women who have undergone autologous stem cell transplant.

Romidepsin has been FDA-approved for treating relapsed T-cell lymphoma. It is possible that in people who are at risk of their disease coming back (relapse), romidepsin could be used to prevent or delay the T-cell lymphoma from returning. The study will determine if giving romidepsin after the autologous stem cell transplant is safe and will prevent or delay the T-cell lymphoma from returning.

Participants will receive high dose chemotherapy followed by the stem cell transplant. Between 42 and 80 days after the transplant, participants will receive their first dose of romidepsin via infusion. Participants will continue to receive romidepsin every other week until 1 year after the stem cell transplant. If a participant’s disease has not progressed 1 year after the transplant, he/she will continue on romidepsin for another year.

World Health Organization Says Herbicide May Cause Non-Hodgkin Lmyphoma

Glysophosate is a herbicide with the highest production volume of all herbicides. In the United States it is currently marketed under the trade name Roundup, and use has increased with the introduction of genetically modified crops resistant to glysophosate. Recently experts from the International Agency for Research on Cancer of the World Health Organization met and assessed the carcinogenicity of different herbicides. In glysophosate they found an increased risk for non-Hodgkin lymphoma:

Case-control studies of occupational exposure in the USA,14 Canada,6 and Sweden7 reported increased risks for non-Hodgkin lymphoma that persisted after adjustment for other pesticides. The AHS cohort did not show a significantly increased risk of non-Hodgkin lymphoma. In male CD-1 mice, glyphosate induced a positive trend in the incidence of a rare tumour, renal tubule carcinoma. A second study reported a positive trend for haemangiosarcoma in male mice.15 Glyphosate increased pancreatic islet-cell adenoma in male rats in two studies. A glyphosate formulation promoted skin tumours in an initiation-promotion study in mice.

Glyphosate has been detected in the blood and urine of agricultural workers, indicating absorption…Glyphosate and glyphosate formulations induced DNA and chromosomal damage in mammals, and in human and animal cells in vitro. One study reported increases in blood markers of chromosomal damage (micronuclei) in residents of several communities after spraying of glyphosate formulations.16 Bacterial mutagenesis tests were negative. Glyphosate, glyphosate formulations, and AMPA induced oxidative stress in rodents and in vitro. The Working Group classified glyphosate as “probably carcinogenic to humans”.

We will continue to follow this story as more information becomes available and update guidelines accordingly.