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Promising combo tackles Hard-to-Treat lymphoma

NCT ID NCT00428142

Disease control Sponsor: NCIC Clinical Trials Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tested whether adding the drug bortezomib to a standard chemotherapy and antibody regimen (BCVP-R) could improve outcomes for 95 patients with advanced follicular lymphoma. The study measured how many patients had a complete response and how often severe nerve side effects occurred. The goal was to find a more effective first-line treatment for this slow-growing blood cancer.

What this could mean

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

Active substance
bortezomib (a drug that blocks cancer cell growth) added to cyclophosphamide, vincristine, prednisone, and rituximab
What this could lead to
If this combination works well, it could offer a more effective first-line treatment option for people with advanced follicular lymphoma, potentially improving response rates and delaying disease progression.
What could go wrong
This is a phase II trial with only 95 participants, so results are preliminary. The added drug bortezomib may cause nerve damage or pain, and the overall benefit over standard therapy is not yet proven in larger studies.

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

95 people

The number who actually took part.

Started

May 2007

Finished

Jan 2012

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 to 120 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.

DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following criteria: * Stage III or IV disease * Grade 1, 2, or 3 disease requiring systemic first-line treatment * No transformation to diffuse large cell lymphoma * At least 1 bidimensionally measurable lesion meeting 1 of the following criteria: * Lymph nodes \> 1.5 cm x 1.0 cm by physical exam or CT scan * Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm (e.g., skin lesions or nodules) by physical exam * Must have a medical indication for treatment, as indicated by 1 of the following: * Presence of constitutional symptoms that are attributed to lymphoma (e.g., B symptoms, including night sweats, fever, weight loss, fatigue, or pain) * Lymphadenopathy that requires treatment based on presence of associated symptoms, potential threat to organ function (e.g., ureteric compromise from retroperitoneal disease), or degree of enlargement (i.e., \> 5 cm) * Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow involvement by lymphoma or from splenomegaly and hypersplenism) * Immune-related complications of lymphoma that require therapy * Rate of disease progression for which observation is deemed inappropriate * No history of any other lymphoproliferative disorder or evidence of transformation to an aggressive histology lymphoma * No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Platelet count ≥ 75,000/mm\^3\* * Absolute neutrophil count ≥ 1,000/mm\^3\* * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma) * Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French * Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study * No history of other malignancies, except for the following: * Adequately treated nonmelanoma skin cancer * Curatively treated in situ cancer of the cervix * Ductal carcinoma in situ of the breast (as long as radiation limitation is not exceeded) * Other solid tumors curatively treated with no evidence of disease for \> 5 years * No history of allergic reactions attributed to compounds containing boron or mannitol * No history of an unusual or severe allergic reaction to rituximab or similar agent * No pre-existing neuropathy ≥ grade 2 * No known HIV infection * No other serious illness or medical condition that would preclude study participation, including any of the following: * Active, uncontrolled bacterial, fungal, or viral infection * Significant cardiac dysfunction * Cardiovascular disease NOTE: \*Exceptions will be allowed for values below these thresholds in patients with marrow involvement by lymphoma or lymphoma-related hypersplenism PRIOR CONCURRENT THERAPY: * No prior systemic therapy for lymphoma * No prior bortezomib, cyclophosphamide, or vincristine * At least 4 weeks since prior radiotherapy that involved ≤ 25% of functioning bone marrow and recovered * Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy or if the irradiated field is not a significant marrow-bearing area * At least 2 weeks since prior major surgery * No other concurrent anticancer therapy, investigational agents, corticosteroids (except for physiologic replacement or antiemesis), cytotoxic chemotherapy, or immunotherapy

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Conditions

The condition(s) this trial relates to.

follicular lymphoma lymphoma

As listed by the trial registrant

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

Lymphoma

Contacts and locations

Locations

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2, Canada

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5, Canada

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1, Canada

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Humber River Regional Hospital

    Toronto, Ontario, M9N 1N8, Canada

  • London Regional Cancer Program

    London, Ontario, N6A 4L6, Canada

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6, Canada

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Regional Cancer Program of the Hopital Regional

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

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