Lenalidomide for recurrent Burkitt's Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
recurrent Burkitt's Lymphoma+22 More
Lenalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat patients with lymphoma.

See full description

Eligible Conditions

  • recurrent Burkitt's Lymphoma
  • Grade 3a Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Refractory Burkitt Lymphoma
  • Refractory Follicular Lymphoma
  • Recurrent Follicular Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Recurrent Grade 1 Follicular Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Waldenstrom's Macroglobulinemia Recurrent

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Lenalidomide will improve 2 primary outcomes and 4 secondary outcomes in patients with recurrent Burkitt's Lymphoma. Measurement will happen over the course of Up to 28 days.

Year 5
Overall Survival (OS)
Year 5
Progression free survival (PFS)
Up to 28 days
Maximum tolerated dose (MTD) defined as the dose level at which no more than one of 6 patients experiences a dose-limiting toxicity summarized by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Up to 5 years
Complete response rate (CR) in patients
Incidence of adverse events summarized by NCI CTCAE version 4
Overall Response Rate (ORR)

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Treatment (lenalidomide, nivolumab)
1 of 1
Experimental Treatment

This trial requires 102 total participants across 1 different treatment group

This trial involves a single treatment. Lenalidomide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (lenalidomide, nivolumab)Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 60 minutes on days 1 and 15 of courses 1-4 and on day 1 of courses 5-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for recurrent Burkitt's Lymphoma or one of the other 22 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
PHASE I: Histologically confirmed B-cell NHL with any of the following subtypes: DLBCL, mantle cell lymphoma (MCL), FL, marginal zone lymphoma (MZL) and lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia (LL/WM), Burkitt's lymphoma (BL); patients with histological transformation to DLBCL from indolent lymphoma, primary mediastinal lymphoma and grey zone lymphoma are eligible
PHASE I: Histologically confirmed classical or lymphocyte predominant Hodgkin's disease that is relapsed or refractory after at least one prior chemotherapy
PHASE I: Patients must have received at least one prior therapy; prior autologous stem cell transplant is permitted; patients with DLBCL who have not had prior high-dose therapy (HDT)/autologous stem cell transplant (ASCT) must be ineligible for transplant; prior lenalidomide is not permitted if patients have progressed on therapy
PHASE IB DOSE EXPANSION: Histologically confirmed classical or lymphocyte predominant Hodgkin's disease
PHASE IB DOSE EXPANSION: Patients must have received at least one prior therapy; prior autologous stem cell transplant is permitted; patients who have not had prior HDT/ASCT must be ineligible for transplant; prior lenalidomide is not permitted if patients have progressed on therapy
Cohort 1: with only de novo DLBCL or transformed indolent Non-Hodgkin's lymphoma (excludes Richter's syndrome).
Cohort 2: with only FL of grade 1, 2 or 3a
PHASE II: Patients must have received at least one prior therapy (in patients with transformed DLBCL must have received at least one prior therapy; prior autologous stem cell transplant is permitted; patients with DLBCL who have not had prior HDT/ASCT must be ineligible for transplant; prior lenalidomide is not permitted if patients have progressed on therapy
Be willing and able to provide written informed consent/assent for the trial
Have evaluable disease

Patient Q&A Section

How many people get lymphoma a year in the United States?

"It is estimated that 25,600 people will be diagnosed with lymphoma in 2030. The high number of cases at the time of diagnosis emphasizes the need for improved diagnostic accuracy and development of sensitive, specific and rapid diagnostic technologies for detection of this form of cancer and for its related clinical management." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"Lymphoma is a neoplasm (a tumor) that belongs to the category of blood cell tumors. It can occur in almost every organ that generates lymphoid cells, such as the bone marrow, the spleen, lymph nodes, and the brain. Lymphoma consists of a group of blood cancer cells that can infiltrate the bone marrow or lymph nodes, grow outside of the bone marrow, or be spread along the bloodstream to other parts of the body. Lymphoma can result in a rapid deterioration of lymph node and bone marrow cells, with symptoms of fever, weight loss, pain, swelling, and feeling tired. It is not necessarily related to cancer, although it may be. It is also not necessarily cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma?

"While lymphoma treatment seems to be evolving in a manner similar to other malignant neoplasms, with an increasing number of effective treatments and chemotherapy regimens, the long-term prognosis for these patients still remains poor. Furthermore, the survival rate, if any, from aggressive lymphoma has not really changed over the past few decades." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"Signs are frequently vague. Some of their characteristics are as follows: tender lymph nodes, swollen lymph nodes, lump in the neck, painless swelling in the mouth/cheeks, and unexplained weight loss. It is not only a symptom but the symptoms can be the first signs of lymphoma. Symptoms can be vague in lymphoma, so a good diagnosis and treatment in these cases are necessary\n" - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"Most lymphomas are highly curable (95%). However, certain lymphomas are more easily cured, such as stage 0 or 1 follicular and marginal zone lymphomas, lymphomas with a high B-symptom index, indolent low-grade lymphomas, and stage 0 or 1 small lymphocytic lymphoma of MALT type (SLLT). The most feared disease, Hodgkin's disease, is not curable. Patients should therefore be informed regularly that if a lymphoma recurs after a remission of <2 yr it has a bad prognosis." - Anonymous Online Contributor

Unverified Answer

What causes lymphoma?

"This is one of the largest case series examining the possible risks factors for lymphoma. It does not support the hypothesis that lymphoma is related to, or a consequence of alcohol consumption." - Anonymous Online Contributor

Unverified Answer

Has lenalidomide proven to be more effective than a placebo?

"Lenalidomide did not prove to be more effective than a placebo for patients with previously treated relapsed/refractory indolent B-cell non-Hodgkin's lymphoma who had received 2 or more prior lines of therapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma?

"Clinical trials could potentially help by providing high quality evidence for effective treatment but they also have the potential to fail by creating high expectations of benefit which may then lead to the abandonment of treatments and poor adherence. We propose that a thorough consultation of a clinician and patient is of great importance before clinical trials are contemplated." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"The survival rates in cases of high-grade NHL are lower than low-grade NHL. The survival rates in cases of diffuse-type NHL and anaplastic-type NHL are lower, while survival rates of cases with non-Hodgkin lymphoma are higher. Survival rate is higher in males than in females irrespective of NHL type. Survival rate of cases with NHL is higher than in the general population. Survival rate of cases with NHL is lower than the survival rate of the general population. Survival rate in cases of B-cell lymphoma is higher than that of T-cell lymphoma. Survival rate of cases with aggressive NHL is lower than that of late-stage NHL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"Until recently, there has been little research published in the English language in the areas of lymphoma. Researchers have identified two major areas of research for lymphoma: (1) the biologic and genetic mechanisms of lymphomas; and (2) new approaches to treatment of lymphoma." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in lenalidomide for therapeutic use?

"Lenalidomide has evolved as a therapeutic option for the treatment of relapsed, refractory and refractory-indeterminate multiple myeloma. In a recent study, findings of ongoing trials evaluating the safety and efficacy of lenalidomide in patients with multiple myeloma are encouraging with an excellent safety profile and tolerability. summary: This article discusses the use of lenalidomide for treatment of multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma?

"The treatment of lymphoma has not evolved since the early 1930s. Chemotherapeutic agents used to treat cancers have not been improved; therefore, we had to change our standard approach to treating cancers by using more sophisticated techniques than those used to treat lymphoma as we did. What has changed is the understanding of cancers and the new drugs and techniques for treating them have increased the quality of life for patients with cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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