IRB #

STUDY00018286

Title

[NCI CIRB] A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission

Principal Investigator

Sarah Nagle

Study Purpose

The study compares overall survival in patients with mantle cell lymphoma in complete remission who receive an autologous stem cell transplant then receive maintenance rituximab (rituxan) with patients who receive rituximab (rituxan) without an autologous stem cell transplant and receive rituximab (rituxan), to study outcomes based on disease markers on tumor tissue before treatment. The study will evaluate disease progression and any complications, such as infections, hospitalizations, and need for immune globulin infusions. The study will also evaluate the effects of tobacco on treatment.

Medical Condition(s)

Mantle Cell Lymphoma
MCL
Lymphoma

Eligibility Criteria

- Patients must be at least age 18 to maximum age of 70.
- Patients must have mantle cell lymphoma confirmed by evaluation of tissue.
- Patients must be willing and eligible for an autologous stem cell transplant
- Patients must be receiving or have completed induction chemotherapy within 60 days of the initial pre-registration, with a maximum of 300 days.
- Patients who have completed induction therapy must show partial or complete response, without evidence of disease progression.
- Up to two chemotherapy regimens are allowed if there has been continuous response, at least a partial response from time of diagnosis.
- There must be no history of mantle cell lymphoma involving the central nervous system (radiculopathy symptoms are not considered involvement of central nervous system).
- There must be an acceptable tissue specimen available for testing from original diagnostic biopsy.

After meeting the above criteria, in order to proceed with the next step of the study:
- Results from the tissue testing must identify molecular markers as either MRD Indeterminate or identified.
- Induction therapy must be completed within 120 days before this step, and not more than 300 days since the first dose of chemotherapy. If you are randomized to the transplant arm, your transplant day ("Day 0") must not be more than 365 days after first dose of induction therapy.
- Patients must have received at least four (4) cycles of induction chemotherapy.
- Up to two regimens of chemotherapy are allowed, as long as there has been a continuous response throughout.
- Patients must have achieved a radiologic complete or partial response as defined by Lugano Criteria.
- Patients must meet institutional eligibility requirements for a stem cell transplant, including heart, kidney, liver, and lung function.
- HIV positive patients are not excluded if their HIV is sensitive to antiretroviral therapy and other HIV-specific requirements.
- Patients must not have had prior malignancies for at least 3 years, except non-melanoma skin cancer, low grade, prostate carcinoma managed with observation and stable for at least 6 months.
- Women must not be pregnant or breast-feeding due to potential risks to the fetus or infant.
- Females who can become pregnant must have a negative pregnancy test.
- Females who can become pregnant must use an acceptable method of contraception or use abstinence until 12 months after the end of treatment with the study drug (rituximab).
- Males who are sexually active must use an acceptable method of contraception or use abstinence until 12 months after the end of treatment with the study drug (rituximab).

Age Range

18 - 70

Healthy Volunteers Needed

No

Duration of Participation

3 years treatment period, plus 7 years follow-up for a total of 10 years.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

NCI ECOG-ACRIN
BMT CTN

Recruitment End

04/01/2022

Compensation Provided

No


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