Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo may keep rare lymphoma at bay after transplant

NCT ID NCT00310037

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether giving the drug bortezomib after intensive chemotherapy, immunotherapy, and a stem cell transplant can help prevent mantle cell lymphoma from coming back. 151 patients were randomly assigned to receive bortezomib either as maintenance (long-term) or consolidation (short-term) therapy. The goal was to see how many patients remained cancer-free 18 months after treatment. Results suggest this approach may improve outcomes, but more research is needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bortezomib
What this could lead to
If successful, this approach could help keep mantle cell lymphoma from coming back after intensive treatment, potentially extending the time patients live without their cancer progressing.
What could go wrong
This is a phase 2 trial with a moderate number of participants, so results are not definitive. Bortezomib can cause side effects like nerve damage, fatigue, and low blood counts, and it may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

151 people

The number who actually took part.

Started

Jun 2006

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Documentation of Disease A. Histologic Documentation: * Histologically documented mantle cell lymphoma with co-expression of CD20 (or CD19) and CD5 and lack of CD23 expression by immunophenotyping AND at least one of the following confirmatory tests: * positive immunostaining for cyclin D1; OR * the presence of t(11;14) on cytogenetic analysis; OR * molecular evidence of bcl-1/IgH rearrangement. * Cases that are CD5-negative and/or CD23-positive will be eligible provided that the histopathology is consistent with mantle cell lymphoma AND positive for cyclin D1, t(11;14), or bcl-1/IgH rearrangement.A tissue block should be submitted to the CALGB Pathology Coordinating Office for central pathology review. * A diagnosis based on peripheral blood or bone marrow is allowed. If the diagnosis is based only on blood, in addition to the immunophenotype and molecular confirmation above, a peripheral blood smear must be available for central pathology review. If the diagnosis is based on a bone marrow biopsy, the tissue block should be submitted. * Note: Failure to submit pathology materials within 60 days of patient registration will be considered a major protocol violation. B. Extent of Disease: * Stage I-IV. Patients with nodular histology mantle cell lymphoma must have Ann Arbor stage III or IV disease to be eligible. Patients with mantle zone histology will not be eligible because of their relatively favorable prognosis. Patients with other mantle cell histologies are eligible regardless of stage. * No active CNS disease defined as symptomatic meningeal lymphoma or known CNS parenchymal lymphoma. A lumbar puncture demonstrating mantle cell lymphoma at the time of registration to this study is not an exclusion for study enrollment. 2. Prior Treatment: A. Patients must be previously untreated or have received no more than one prior cycle of chemotherapy and/or rituximab treatment. B. No prior radiation therapy for mantle cell lymphoma. C. ≥ 2 weeks since major surgery. D. ≥ 3 weeks since prior chemotherapy. 3. Age Eligibility: Age ≥ 18 years and \< 70 years 4. Murine Products Hypersensitivity Eligibility: No known hypersensitivity to murine products. 5. Use of Systemic Corticosteroids Eligibility: No medical condition requiring chronic use of systemic corticosteroids. 6. Eligibility Criteria on HIV Infection: No HIV infection. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk. 7. Non-pregnant and non-nursing: Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. 8. HepBSAg or HepC Ab Eligibility: Patients who test positive for HepBSAg or HepC Ab are eligible provided all of the following criteria are met: A. bilirubin ≤ 2 x upper limit of normal; AND B. AST ≤ 3 x upper limit of normal; AND C. liver biopsy demonstrates ≤ grade 2 fibrosis and no cirrhosis. Hepatitis B surface Ag(+) patients will be treated with lamivudine (3TC) throughout protocol therapy and for 6-12 months thereafter. 9. Secondary Malignancy Eligibility: Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. This includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis. Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse. 10. Initial Required Laboratory Values: * LVEF by MUGA or ECHO ≥ 45% * Creatinine ≤ 2.0 mg/dL * Total Bilirubin ≤ 2.0 mg/dL (Unless attributable to Gilbert's Disease) * u-HCG or serum HCG Negative (If patient of childbearing potential).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mantle cell lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mantle cell lymphoma

Contacts and locations

Locations

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240, United States

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761, United States

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615, United States

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Community Cancer Center

    Normal, Illinois, 61761, United States

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350, United States

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115, United States

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Eureka Community Hospital

    Eureka, Illinois, 61530, United States

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401, United States

  • Graham Hospital

    Canton, Illinois, 61520, United States

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701, United States

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520, United States

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761, United States

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644, United States

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462, United States

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603, United States

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354, United States

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356, United States

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362, United States

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354, United States

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295, United States

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040, United States

  • Mason District Hospital

    Havana, Illinois, 62644, United States

  • McDonough District Hospital

    Macomb, Illinois, 61455, United States

  • Memorial Hospital

    Carthage, Illinois, 62321, United States

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636, United States

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042, United States

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002, United States

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462, United States

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350, United States

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615, United States

  • Perry Memorial Hospital

    Princeton, Illinois, 61356, United States

  • Proctor Hospital

    Peoria, Illinois, 61614, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001, United States

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210, United States

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110, United States

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115, United States

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470, United States

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.