Comparing Three Chemotherapy Treatments for Newly Diagnosed Mantle Cell Lymphoma
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT04115631
This study is testing three different combinations of chemotherapy drugs to see which works best for patients with newly diagnosed mantle cell lymphoma, a type of blood cancer. The goal is to find out if one combination is more effective or has fewer side effects than the others.
Patient Parameters
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Program Overview
This clinical trial is comparing three different chemotherapy treatments to see how well they work for people with newly diagnosed mantle cell lymphoma. The treatments include a mix of drugs that work in various ways to stop cancer cells from growing and spreading. The study aims to find out if one of these drug combinations is better than the usual treatment for this type of cancer.
Description
The study has two main goals: to see how many patients have no signs of cancer on scans and in their blood after treatment, and to track how long patients live without the cancer getting worse. Researchers will also look at side effects, how well the treatment works overall, and how many patients can successfully collect stem cells for future use.
Patients will be randomly assigned to one of three treatment groups:
- Group A: Patients receive bendamustine and rituximab for the first three cycles, followed by rituximab and cytarabine for the next three cycles.
- Group B: Patients receive acalabrutinib, bendamustine, and rituximab for the first three cycles, followed by acalabrutinib, rituximab, and cytarabine for the next three cycles.
- Group C: Patients receive acalabrutinib, bendamustine, and rituximab for up to six cycles.
After finishing the treatment, patients will have follow-up visits every three months for three years, and then every six months until ten years after treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of mantle cell lymphoma with specific genetic markers.
- Must not have received any previous treatment for mantle cell lymphoma.
- Must have at least one measurable tumor.
- Must have a performance status score of 0-2, indicating good overall health.
- Must have adequate blood counts and organ function based on specific tests.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control during and after the study.
- Men must agree to use birth control during and after the study.
- Must not be taking certain medications that could interfere with the study drugs.
- Must provide a tumor sample or blood sample for research purposes.
- Must not have any other serious medical conditions that could affect participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
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