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CompletedNCT00031668Updated Apr 1, 2020

Radiation Therapy in Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation

An interventional study of radiation therapy in Lymphoma, sponsored by NCIC Clinical Trials Group. Completed at 9 sites in Canada. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by NCIC Clinical Trials Group · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2001, registered Mar 2002).
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy after stem cell transplantation is more effective than stem cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone autologous stem cell transplantation.

Read the detailed description

OBJECTIVES:

  • Compare the 3-year progression-free survival of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation with or without involved-field radiotherapy.
  • Compare the overall survival of patients treated with these regimens.
  • Compare 3-year progression-free disease within and outside radiotherapy fields in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to pre-salvage chemotherapy (primary refractory disease vs relapse), response to post-salvage chemotherapy (complete/unconfirmed complete vs partial), and participating center. Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3-5 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients undergo observation only. Quality of life in arm I is assessed at baseline, on day 1 of IFRT, at weeks 2 and 4 during IFRT, at 1 month, 4 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. Quality of life in arm II is assessed at baseline, 1 month, 2 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 4.2 years.

02

Conditions studied

  • Lymphoma

Keywords

  • Waldenstrom macroglobulinemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • anaplastic large cell lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

NCIC Clinical Trials Group is the lead sponsor of 114 studies on the registry; none are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 7 (26%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma

    • Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma)
    • Previous indolent lymphoma (follicular center cell lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
    • Peripheral T-cell lymphoma
    • Anaplastic large cell lymphoma (T cell or null cell)
    • Small non-cleaved Burkitt-like lymphoma
  • Relapsed or refractory disease after first-line anthracycline-based chemotherapy

    • Bulky disease, nodal or extranodal

      • Clinically or radiographically measurable mass at least 5 cm in diameter OR
    • Non-bulky disease, nodal or extranodal, excluding diffuse organ (lung, liver, kidney, or bone marrow) involvement

      • Clinically or radiographically measurable disease more than 1.5 cm in greatest transverse diameter
  • Biopsy at relapse not required except for transformed lymphomas

    • Patients with transformed lymphoma at diagnosis, but with indolent histology without transformation at relapse, are not eligible
  • No patients with stage IA or IIA disease at initial diagnosis who, at time of relapse or diagnosis of refractory disease prior to salvage therapy, remained in stage IA or IIA, with no new disease sites, without having received radiotherapy
  • Received up to 2 regimens and 4 courses of salvage chemotherapy

    • Monoclonal antibodies (e.g., rituximab) are not considered salvage chemotherapy
    • Achieved complete response (CR), unconfirmed CR, or partial response (PR) if bulky disease OR
    • Achieved PR (but not CR) if non-bulky disease
  • No residual disease involving extranodal organs diffusely (e.g., liver, lung, bone, kidney, or leptomeningeal) after salvage chemotherapy
  • Planned autologous hematopoietic stem cell transplantation (ASCT)

    • ASCT conditioning must be with high-dose BEAM (carmustine, etoposide, cytarabine, and melphalan) chemotherapy
  • No disease progression after ASCT
  • No major organ complication or poor hematologic recovery from ASCT that would preclude initiation of study radiotherapy within 14 weeks after ASCT
  • No more than 2 non-contiguous nodal or extranodal areas of bulky/residual disease requiring more than 2 separate involved-field radiotherapy volume arrangements (e.g., field arrangement covering up to 2 involved lymph node regions or extranodal sites, with or without 1 adjacent nodal/region or extranodal site)
  • No active CNS lymphoma (parenchymal brain and/or leptomeningeal)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior radioimmunotherapy

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior total body irradiation
  • No prior radiotherapy to the site of bulky disease or residual tumor

Surgery:

  • Not specified

Other:

  • No other concurrent anti-cancer therapy unless documentation of disease progression
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

  • Radiationradiation therapy
06

Study locations

9 sites
  • Tom Baker Cancer Center - Calgary
    Calgary, Alberta T2N 4N2, Canada
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
  • Newfoundland Cancer Treatment and Research Foundation
    St. Johns, Newfoundland and Labrador A1B 3V6, Canada
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • Cancer Care Ontario-London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Toronto Sunnybrook Regional Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec H1T 2M4, Canada
  • McGill University
    Montreal, Quebec H2W 1S6, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00031668
Lead sponsor
NCIC Clinical Trials Group
Responsible party
Sponsor
First posted
Jul 1, 2003
Start date
Jan 31, 2001
Primary completion
Feb 10, 2009
Completion
Feb 10, 2009
Last update
Apr 1, 2020

Study contacts

Richard Tsang, MD, FRCPC
study chair · Princess Margaret Hospital, Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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