RECRUITING

Ultra Low Dose Radiation Delivered Before or After Chemotherapy-Free Targeted Therapy in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Conditions

Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.

Official Title

Phase II Trial to Assess the Efficacy of Ultra Low Radiation Dose Delivered Prior or After Chemotherapy Free Targeted Therapy for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

Quick Facts

Study Start:2019-06-14

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04054167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy. Biopsy does not need to be done of the lesions to be treated. * Patients can be newly diagnosed or previously treated relapsed and/or refractory MCL. * Understand and voluntarily sign an IRB-approved informed consent form. * Age ≥ 18 years at the time of signing the informed consent. * Patients must have bi-dimensional measurable disease (Measurable disease by CT scan defined as at least 1 lesion that measures =/\>1.5 cm in single dimension.) Patient presenting with lesions in the presence of leukemia phase (peripheral blood involvement), non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible. * Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (see Appendix 1). * Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty. * Females of childbearing potential (FCBP)1 must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 30 days after the last dose of study treatment. * Male patients must use an effective barrier method of contraception during the study and for 30 days following the last dose of study treatment if sexually active with a female of childbearing potential. * Serum bilirubin \<1.5 mg/dl and Cr Clearance ≥ 30 mL/min, platelet count \>25,000/mm3 and absolute neutrophil count (ANC) \> 1,000/mm3, AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present. * Patients who have bone marrow infiltration by MCL are eligible if their ANC is ≥ 1000/mm3 \[growth factor not allowed\] or their platelet level is ≥ 25,000/mm3	* Has had prior radiation therapy to the potential radiation target such that additional radiation therapy is considered unsafe by the treating radiation oncologist * Has a diagnosis of active scleroderma or lupus or any other autoimmune disease that by the opinion of the treating radiation oncologist would put the patient at unacceptable risk of toxicity. * Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, COPD, renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. * Pregnant or breast-feeding females. * All patients with central nervous system lymphoma that needs attention prior to treatment of the lesions. * If the total fields of radiation will include a marrow volume of more than 40%. Physician can include as many fields to respect the 40 % of marrow volume and come back in 4-6 weeks later to address the rest of the disease after insuring that the Blood counts are adequate. Blood counts should be back to back to the numbers prior to starting the first phase of radiation +- 10% variance. * If given radiation prevent them from going through an alternative phase I trial

Inclusion Criteria

Exclusion Criteria

* Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy. Biopsy does not need to be done of the lesions to be treated.
* Patients can be newly diagnosed or previously treated relapsed and/or refractory MCL.
* Understand and voluntarily sign an IRB-approved informed consent form.
* Age ≥ 18 years at the time of signing the informed consent.
* Patients must have bi-dimensional measurable disease (Measurable disease by CT scan defined as at least 1 lesion that measures =/\>1.5 cm in single dimension.) Patient presenting with lesions in the presence of leukemia phase (peripheral blood involvement), non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible.
* Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately.
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (see Appendix 1).
* Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
* Females of childbearing potential (FCBP)1 must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 30 days after the last dose of study treatment.
* Male patients must use an effective barrier method of contraception during the study and for 30 days following the last dose of study treatment if sexually active with a female of childbearing potential.
* Serum bilirubin \<1.5 mg/dl and Cr Clearance ≥ 30 mL/min, platelet count \>25,000/mm3 and absolute neutrophil count (ANC) \> 1,000/mm3, AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present.
* Patients who have bone marrow infiltration by MCL are eligible if their ANC is ≥ 1000/mm3 \[growth factor not allowed\] or their platelet level is ≥ 25,000/mm3

* Has had prior radiation therapy to the potential radiation target such that additional radiation therapy is considered unsafe by the treating radiation oncologist
* Has a diagnosis of active scleroderma or lupus or any other autoimmune disease that by the opinion of the treating radiation oncologist would put the patient at unacceptable risk of toxicity.
* Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, COPD, renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.
* Pregnant or breast-feeding females.
* All patients with central nervous system lymphoma that needs attention prior to treatment of the lesions.
* If the total fields of radiation will include a marrow volume of more than 40%. Physician can include as many fields to respect the 40 % of marrow volume and come back in 4-6 weeks later to address the rest of the disease after insuring that the Blood counts are adequate. Blood counts should be back to back to the numbers prior to starting the first phase of radiation +- 10% variance.
* If given radiation prevent them from going through an alternative phase I trial

Contacts and Locations

Study Contact

Bouthaina S Dabaja

CONTACT

713-792-5132

bdabaja@mdanderson.org

Principal Investigator

Bouthaina S Dabaja

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Bouthaina S Dabaja, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-14

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-06-14

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma