Tag: lymphoma cancer

ASCO2015: A phase I/II Trial of the Combination of Romidepsin and Lenalidomide in Patients with Relapsed/Refractory Lymphoma and Myeloma: Activity in T-cell Lymphoma.

Picture2By Dr. Jia Ruan 

Romidepsin, a histone deacetylase inhibitor, and lenalidomide, an immunomodulatory agent, have previously shown efficacy and a lack of cumulative toxicity in the treatment of patients with relapsed/refractory lymphoma and myeloma. Results from phase I of this trial were previously reported in ASCO 2014. The maximum tolerated dose in cycle 1 for romidepsin was 14 mg/m2 IV on days 1, 8, and 15, while lenalidomide was 25 mg oral on days 1-21 of a 28-day cycle. In this trial patients were treated to progression or intolerance.  Results of patients with t-cell lymphoma were reported at the 2015 ASCO meeting.

21 patients (10 CTCL, 11 PTCL) with a median age of 64 were enrolled in this trial. 15 of these patients were treated at the maximum tolerated dose. 19 of these patients were evaluable for efficacy with an overall response rate of 53%. For patients the median time of response was 7.3 weeks, median event free survival was 15.5 weeks, and median overall survival was not reached. 10 out of 21 patients remained on therapy with 7 discontinued for disease progression, 3 for toxicity, and 1 for stem cell transplant. Side effects were generally expected and manageable.

Results from this study confirm that the romidepsin and lenalidomide combination has significant activity in relapsed and refractory T-cell lymphoma. This study demonstrated that novel biologic agent and combinations can be effective and well-tolerated treatment options for patients with T-cell lymphoma, who may be poor candidates for intensive therapy or have chemotherapy-resistant disease.

New Clinical Trial: A Phase II Trial of PET-Directed Therapy for Limited Stage DLBCL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with Diffuse Large B-cell Lymphoma (DLBCL). The study sponsor is the Southwest Oncology Group, 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

  • Men and women age 18 years and older
  • Patient must have biopsy proven diffuse large B-cell lymphoma
  • Patient cannot have received prior chemotherapy, radiation, or antibody therapy for lymphoma
  • Detailed eligibility reviewed when you contact the study team

Study Details 

This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient’s response to treatment and help plan the best treatment.

Primarily, this study will assess the 5 year progression- free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).

Patients will be stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).

  • Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.
  • FDG/PET – Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.
  • Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.
  • Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.
  • After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.

ASCO 2015 – WCMC Related Abstracts

In two weeks the 2015 meeting of the American Society of Clinical Oncology (ASCO) will take place in Chicago, bringing oncology professionals together from around the world. Below are the abstracts Lymphoma Program team members were involved in whole or in part to be presented at ASCO 2015:

CLL
Long-term follow-up of a phase Ib trial of idelalisib (IDELA) in combination with chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory (R/R) CLL including pts with del17p/TP53 mutation

Dose adherence and baseline exposure analysis of the ibrutinib 420 mg dose administered to patients with previously treated chronic lymphocytic leukemia (CLL).

Follicular Lymphoma
A phase III study of ibrutinib in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously treated follicular lymphoma or marginal zone lymphoma

Non-Hodgkin Lymphoma
AUGMENT: A randomized, phase 3 trial in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) to compare efficacy and safety of lenalidomide plus rituximab (R2) versus placebo plus rituximab 

Bendamustine and rituximab and lenalidomide (BRR) in the treatment of relapsed and refractory low grade non-Hodgkin lymphoma (NHL): Final results of phase 1 study NCCTG N1088/ALLIANCE 

Safety of idelalisib in B-cell malignancies: Integrated analysis of eight clinical trials

A phase I/II trial of the combination of romidepsin and lenalidomide in patients with relapsed/refractory lymphoma and myeloma: Activity in T-cell lymphoma 

Waldenstrom’s Macroglobulinemia
Idelalisib monotherapy and durable responses in patients with relapsed or refractory Waldenstroms Macroglobulinemia (WM)

Please look to this space for further updates about developments in ASCO 2015.