Clinical trial Phase 3 Interventional Ages 18 to 70

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

Run by ECOG-ACRIN Cancer Research Group · NCT03267433 · Data updated 2026-11-12

Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2027-01-31.

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…

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment689 (estimated)
SponsorECOG-ACRIN Cancer Research Group
Research network
Drugs / interventionsAutologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspirate, Bone Marrow Biopsy, Computed Tomography, Positron Emission Tomography, Rituximab, Rituximab and Hyaluronidase Human
Locations375 sites (Saudi Arabia, United States)
Trial IDNCT03267433 on ClinicalTrials.gov

What this trial studies

PRIMARY OBJECTIVE: I. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first complete remission (CR) who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (without auto-HCT). SECONDARY OBJECTIVES: I. To compare progression-free survival in MCL patients in MRD-negative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone. II. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. III. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive partial response (PR) patients who undergo auto-HCT followed by 3 years of maintenance rituximab. IV. To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. V. To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab. VI. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT. VII. To determine the …

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
* Age \>= 18 and =\< 70 years
* Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH). If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until step 1 registration; patients may register to step 0 without a documented Ki-67 index
* In the opinion of the enrolling physician, patients must be felt to be a candidate for autologous stem cell transplantation
* Patient may be about to begin, be receiving or have completed induction therapy within 120 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0

  * For patients who have completed induction therapy and have been restaged, restaging evaluation must show status of partial (PR) or complete response (CR); post-induction patients with evidence of clinical disease progression are not eligible for preregistration
  * Up to two regimens of therapy (conventional chemotherapy, antibody therapy, or an oral regimen) are allowed as long as a continuous response was ongoing throughout therapy; overall, a partial response needs to have been achieved (using studies at the time of diagnosis as the baseline)

    * NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen
* Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement
* Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence

  * NOTE: If adequate tumor tissue is not available, peripheral blood collected prior to start of treatment with high disease burden (\> 5%) is acceptable for molecular marker identification (ID) testing

    * Adaptive Biotechnologies will forward results within fourteen (14) days of receipt of any stored (e.g. frozen or FFPE) tumor tissue specimen to the submitting institution and to the ECOG-American College of Radiology Imaging Network (ACRIN) Operations Office
  * NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient's disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment

    * Adaptive Biotechnologies will forward results within ten to fourteen (10-14) days of receipt of fresh peripheral blood specimen to the submitting institution and to the ECOG-ACRIN Operations Office
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have met eligibility criteria for the screening step 0
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): The proliferation rate, using Ki-67 or MIB-1 immunohistochemistry (=\< 30% versus \> 30% versus "indeterminate" Ki-67 index), must be documented for a baseline tumor biopsy specimen
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:

  * Patients are "MRD Indeterminate": ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR
  * ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have completed induction therapy within 150 days prior to registration to step 1, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 \[C1\] day 1 \[D1\]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant ("day 0") must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given

  * Patient must have received at least four (4) cycles of induction therapy
  * Up to two regimens of therapy (conventional chemotherapy, antibody therapy, or an oral regimen) are allowed as long as a continuous response was ongoing throughout therapy

    * NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): In the opinion of the enrolling physician, patients must be felt to be a candidate for autologous stem cell transplantation
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the below criteria:

  * HIV is sensitive to antiretroviral therapy
  * Must be willing to take effective antiretroviral therapy that has minimal overlapping toxicity and pharmacokinetic interactions with protocol therapy
  * No history of HIV-related opportunistic disease or acquired immune deficiency syndrome (AIDS)-defining conditions within past 12 months other than historic CD4+ T-cell counts below 200 cells/mm\^3
  * Expected long-term survival if lymphoma were not present
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patient must be disease-free \>= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, melanoma in situ post wide local excision or Mohs surgery, low grade prostate carcinoma (Gleason grade =\< 6) managed with observation that has been stable for at least 6 months
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patient must not be pregnant or breast-feeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used

  * All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  * A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patient of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months post rituximab treatment

Where it's running

  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama, United States
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska, United States
  • Anchorage Radiation Therapy Center
    Anchorage, Alaska, United States
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska, United States
Show 44 more locations
  • Anchorage Oncology Centre
    Anchorage, Alaska, United States
  • Katmai Oncology Group
    Anchorage, Alaska, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska, United States
  • Fairbanks Memorial Hospital
    Fairbanks, Alaska, United States
  • Kingman Regional Medical Center
    Kingman, Arizona, United States
  • University of Arizona Cancer Center-Orange Grove Campus
    Tucson, Arizona, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona, United States
  • PCR Oncology
    Arroyo Grande, California, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
  • Contra Costa Regional Medical Center
    Martinez, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, United States
  • UC San Diego Medical Center - Hillcrest
    San Diego, California, United States
  • UCSF Medical Center-Parnassus
    San Francisco, California, United States
  • BASS Medical Group - Lennon
    Walnut Creek, California, United States
  • Rocky Mountain Cancer Centers-Aurora
    Aurora, Colorado, United States
  • The Medical Center of Aurora
    Aurora, Colorado, United States
  • Boulder Community Hospital
    Boulder, Colorado, United States
  • Boulder Community Foothills Hospital
    Boulder, Colorado, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado, United States
  • Rocky Mountain Cancer Centers - Centennial
    Centennial, Colorado, United States
  • Cancer Center of Colorado at Sloan's Lake
    Denver, Colorado, United States
  • Denver Health Medical Center
    Denver, Colorado, United States
  • National Jewish Health-Main Campus
    Denver, Colorado, United States
  • The Women's Imaging Center
    Denver, Colorado, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado, United States
  • Rocky Mountain Cancer Centers-Midtown
    Denver, Colorado, United States
  • SCL Health Saint Joseph Hospital
    Denver, Colorado, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado, United States
  • Rose Medical Center
    Denver, Colorado, United States
  • Mountain Blue Cancer Care Center - Swedish
    Englewood, Colorado, United States
  • Rocky Mountain Cancer Centers - Swedish
    Englewood, Colorado, United States
  • Swedish Medical Center
    Englewood, Colorado, United States
  • The Melanoma and Skin Cancer Institute
    Englewood, Colorado, United States
  • National Jewish Health-Western Hematology Oncology
    Golden, Colorado, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado, United States
  • Grand Valley Oncology
    Grand Junction, Colorado, United States
  • Banner North Colorado Medical Center
    Greeley, Colorado, United States
  • Rocky Mountain Cancer Centers-Greenwood Village
    Greenwood Village, Colorado, United States
  • Good Samaritan Hospital - Cancer Centers of Colorado
    Lafayette, Colorado, United States
  • Rocky Mountain Cancer Centers-Lakewood
    Lakewood, Colorado, United States

+325 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Timothy S Fenske — ECOG-ACRIN Cancer Research Group

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.