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Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. 11 versions Re-verified since Sep 15, 2025, no change to tracked fieldsv15-v25
  2. Site details revised at 1 of 375 sitesv14
  3. Primary endpoint revisedv13 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 374 to 375
    • Study completion date: Jan 31, 2032 to Jan 31, 2027
    • Start date: Mar 6, 2018 to Nov 27, 2017
    • Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Laboratory Biomarker Analysis (Other), Rituximab (Biological) to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspirate (Procedure), Bone…
    • Eligibility criteria expanded, about 313 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 244 words
  4. Study sites: 319 to 374v12
  5. Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Start date: Aug 29, 2017 to Mar 6, 2018v10
  2. Study description revisedv9
  3. Re-verified, no change to tracked fieldsv8
  4. Eligibility criteria expanded, about 23 wordsv7
  5. Re-verified, no change to tracked fieldsv6
  6. Study sites: 1 to 319v5
  7. Re-verified, no change to tracked fieldsv4
  8. Primary completion date: Jan 31, 2021 to Jan 31, 2027
    • Study completion date: Jan 31, 2026 to Jan 31, 2032
    v3
  9. Enrollment target: 640 to 689v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.
Trial Details
NCT Number NCT03267433
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Mantle Cell Lymphoma
Related terms Lymphoma, Mantle-Cell
Enrollment 689 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov