Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of adding ultra low dose radiation (ULDR) to chemotherapy free-targeted therapy (CTFTT) in contributing to a durable overall response in treated locations by estimating overall response rate (ORR) at 3 months. SECONDARY OBJECTIVES: I. To evaluate if UL...

PRIMARY OBJECTIVES: I. To evaluate the efficacy of adding ultra low dose radiation (ULDR) to chemotherapy free-targeted therapy (CTFTT) in contributing to a durable overall response in treated locations by estimating overall response rate (ORR) at 3 months. SECONDARY OBJECTIVES: I. To evaluate if ULDR can improve progression-free survival and overall survival. II. To evaluate the prognostic factors associated with inferior progression-free survival, including patient related and previous treatment related and if radiation can overcome these prognostic factors. III. To evaluate if radiation helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status. OUTLINE: Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Tracking Information

NCT #
NCT04054167
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bouthaina S Dabaja M.D. Anderson Cancer Center