Ibrutinib for Relapse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Relapse+7 More
Ibrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ibrutinib is more effective when combined with rituximab.

See full description

Eligible Conditions

  • Relapse
  • Prolymphocytic Leukaemia (PLL)
  • Recurrent Small Lymphocytic Lymphoma
  • chronic, recurrent Lymphocytic Leukemia

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ibrutinib will improve 1 primary outcome and 7 secondary outcomes in patients with Relapse. Measurement will happen over the course of Up to 24 cycles (96 weeks).

Year 5
Changes in immune parameters (lymphocyte subpopulations, immunoglobulin levels)
The changes in immune parameters in the immunoglobulin levels
The changes in the immune parameters in the lymphocyte subpopulations.
Year 2
Progression-free survival rate
Week 96
Quality of life (QOL)
Up to 5 years
Estimated progression-free survival
Incidence of adverse events
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (ibrutinib)
1 of 2
Arm II (ibrutinib, rituximab)
1 of 2
Experimental Treatment

This trial requires 208 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ibrutinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (ibrutinib)Patients receive ibrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (ibrutinib, rituximab)Patients receive ibrutinib as in Arm I beginning on day 1 or 2. Patients also receive rituximab IV over 3-8 hours on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2-6. Cycles 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
Rituximab
FDA approved
Ibrutinib
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

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 7 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:
Patients must have a diagnosis of CLL/small lymphocytic lymphoma (SLL) or prolymphocytic leukemia (PLL) and be previously treated; given the poor outcome of CLL/SLL/PLL patients with 17p deletion (del) or tumor protein (TP)53 mutation to standard frontline chemo-immunotherapy, such patients will be eligible if they are untreated
Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
Patients must be age >= 18 years at the time of signing informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients of childbearing potential must be willing to practice highly effective birth control (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the study and for 30 days after the last dose of study drug; women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participate
Alanine aminotransferase (ALT) =< 2.5 x ULN
Estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation unless disease related
Free of prior malignancies for 3 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast, who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 3 years prior to study enrollment; if patients have another malignancy that was treated within the last 3 years, such patients can be enrolled, after consultation with the principal investigator, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center
A urine pregnancy test (within 7 days of enrollment date) is required for women with childbearing potential

Patient Q&A Section

What causes leukemia?

"As stated, leukemia can result from a number of factors, such as genetics, exposure to certain chemicals and the environment, or exposure through medical treatment.\n" - Anonymous Online Contributor

Unverified Answer

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

"The estimated number of new cases of acute myeloid leukemia or acute lymphocytic leukemia will peak in 2016, reaching 1.7-3.6 million cases, respectively. The cumulative number of cases of AML or ALL will peak in 2018, reaching 4.3-4.9 million cumulative cases, respectively. However a substantial portion of these cases will be diagnosed during the first 5 years of adulthood, which could potentially delay treatment of people with leukemias. We recommend that the US Preventive Services Task Force recommends that people under the age of 50 receive screening for leukemia and recommend that the screening includes both peripheral blood and bone marrow tests." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"It is known that leukemia cannot be cured and remission is just a period with no signs of disease. However, patients can have a remission, which can extend the time they live before dying." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"This is the most common type of blood cancer which is a cancer of cells in the blood, bone marrow or other parts of the body. A single cell in the body may become cancerous; this is called leukemias, as they occur in the blood and are often called blood cancers. The leukemia is one of the most dangerous types of blood cancer, as there is no cure for it yet." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"In the past year, an increasing number of patients received allogeneic stem cell transplants as treatment for leukemia, especially chronic lymphocytic leukemia (CLL). Most common indications for autologous stem cell transplantations (ASCTs) in patients with CLL are as a part of frontline therapy, although they may be lifesaving. ASCT is the initial treatment option when there are a few weeks left to live. The aim of ASCT before the onset of a progression to refractory disease is to improve the patient prognosis. At the same time patients treated with allosensitizing agents such as alemtuzumab should be carefully observed in order to detect any potential treatment-related adverse events." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"Many people with leukemia have no obvious symptoms. In the United States, leukemia is the most common blood cancer. Other forms of blood cancer are typically detected through screening of high-risk populations such as individuals with family history of the disease, or people with certain heredity, such as BRCA1 genes. Symptoms and signs of leukemia are very common and may appear suddenly, with symptoms including fever, swollen lymph nodes, loss of appetite, anemia, vomiting, diarrhea, and a mass or blister on the surface of the skin. In addition to symptoms, signs can be identified at diagnosis by signs such as red and painful bumps (masses) throughout the body, and a change in the shape of the spleen or liver." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia?

"A variety of factors contribute more than 10% to causation of adult leukemia. The genetic predisposition and/or environmental factors play a part in childhood leukemia. The environmental factors include: ionizing radiation, infections (HIV), metabolic, and dietary factors. Leukemia is diagnosed and treated differently depending on diagnosis. What is a diagnosis? There are different definitions of diagnosis, including the US Food and Drug Administration's definition. It is based on the ICD-10 and can be divided into five components based on: medical causes, anatomical or pathological findings, clinical courses, or laboratory markers as a means of classification." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia?

"The following research is of interest to most doctors, as they often get asked for details about the disease's specific treatments, how to diagnose, how to prevent it or how to fight it, and who suffers most.\n" - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"Overall, the average age the patient was diagnosed with leukemia in Poland is 59 years old. Median age is 58.5. The mean age of patients who survived was 66.5. Younger patients are under 50 years old and they are usually female (median age 56, mean age 57)." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia?

"The odds of developing leukemia are highest if a person is a man, is younger than 45, has been or is currently overweight, has not had an acute illness during the preceding 12 months or has a family history of the disease. The odds of developing leukemia as an adult may increase if the person has been in the Navy for 12 months or in the Air Force for one year or more. The disease becomes less common as people age and the risk of developing leukemia decreases as does the risk of getting a bone marrow transplant from a relative." - Anonymous Online Contributor

Unverified Answer

Is ibrutinib safe for people?

"Ibrutinib is well tolerated at a dose of 50/mg twice per day, with an improved appetite, good quality of life and no significant changes in hematological parameters assessed at baseline, week 24 or 52. This finding is comparable to that previously reported regardless of first-line treatment (ibrutinib or CHOP plus rituximab). The low incidence of drug-related adverse effects is, as expected of an inhibitor of the protein Bruton's tyrosine kinase (Btk) and the protein phosphatase SHP-1/2, and is compatible with clinical development of ibrutinib." - 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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