LymphomaPhase 3NCT00003639
Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
A Phase 3 study testing recombinant interferon alfa, chlorambucil and dexamethasone in people with Lymphoma, run by Scotland and Newcastle Lymphoma Group at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells and slow the growth of non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- recombinant interferon alfa, chlorambucil and dexamethasone
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 1993to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed B cell low grade non-Hodgkin's lymphoma Stage II, III or IV Measurable disease No chronic lymphatic leukemia, prolymphocytic leukemia and hairy cell leukemia, angioimmunoblastic lymphadenopathy, mycosis fungoides, Sezary's syndrome and T-zone lymphoma, plasmacytoma, T cell lymphomas, or centroblastic lymphoma No CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.96 mg/dL AST/ALT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.65 mg/dL OR Creatinine clearance no greater than 40 mL/min Cardiovascular: No history of myocardial infarction in the past 12 months No severe or uncontrolled cardiac failure Other: No history of malignant disease except basal cell carcinoma or carcinoma in situ of the cervix No active peptic ulceration, significant dyspepsia, or history of hematemesis or melena No concurrent medical or psychological condition that may preclude study participation Not pregnant Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy for any malignant disease Prior radiotherapy for localized disease that subsequently relapses permitted Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
About this study
Official title: Randomised Controlled Trial of CID (Chlorambucil, Idarubicin, Dexamethasone) Versus CD (Chlorambucil, Dexamethasone) for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma (Kiel Classification) Followed by Randomised Controlled Assessment of Standard Dose Interferon Versus Low Dose Interferon Versus No Further Therapy as Maintenance Treatment After Remission Induction
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES: I. Compare the remission induction rates and toxicity of chlorambucil plus dexamethasone with or without idarubicin in patients with stage II-IV low grade non-Hodgkin's lymphoma. II. Assess the additional value of a period of consolidation/maintenance treatment utilizing low dose interferon alfa or standard dose interferon alfa versus no further treatment in relationship to the duration of event-free survival in these patients.
OUTLINE: This is a randomized, open label, controlled, multicenter study. Patients are randomized into one of two arms for induction chemotherapy. Arm I: Patients receive oral chlorambucil three times daily for 3 consecutive days, oral idarubicin daily for 3 consecutive days, and oral dexamethasone twice daily for 5 consecutive days every 21 days. Arm II: Patients receive oral chlorambucil three times daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days. Treatment for both arms continues for up to 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses of chemotherapy, patients are reassessed. If they have achieved maximal complete response or good partial response, patients are randomized into one of three arms. Arm I: Patients receive no further treatment until disease progresses. Arm II: Patients receive low dose interferon alfa subcutaneously three times per week for a maximum of 3 years in the absence of disease progression. Arm III: Patients receive standard dose interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of disease progression. Patients are followed every 8-12 weeks for 3 years.
PROJECTED ACCRUAL: There will be 200 patients accrued into this study with approximately 150 patients entering the second phase of this study.
- Conditions
- Lymphoma
- Being tested
- recombinant interferon alfa, chlorambucil, dexamethasone, idarubicin
- Keywords
- stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
chlorambucilDrug
dexamethasoneDrug
idarubicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startNov 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scotland and Newcastle Lymphoma Group
- Sponsor type
- University, hospital or other
- Investigators
- Stephen J. Proctor, MD, FRCP, FRCPath, Study chair, Newcastle-upon-Tyne Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003639
- Sponsor's protocol ID
- CDR0000066724
- Other IDs
- SNLG-NHL-VIII, EU-98034
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of CID (Chlorambucil, Idarubicin, Dexamethasone) Versus CD (Chlorambucil, Dexamethasone) for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma (Kiel Classification) Followed by Randomised Controlled Assessment of Standard Dose Interferon Versus Low Dose Interferon Versus No Further Therapy as Maintenance Treatment After Remission Induction
- ClinicalTrials.gov ID
- NCT00003639
- Acronym / sponsor ID
- CDR0000066724
- Conditions
- Lymphoma
- Keywords
- stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Scotland and Newcastle Lymphoma GroupUniversity, hospital or other
- Study start
- Nov 1993
- First posted
- 16 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: I. Compare the remission induction rates and toxicity of chlorambucil plus dexamethasone with or without idarubicin in patients with stage II-IV low grade non-Hodgkin's lymphoma. II. Assess the additional value of a period of consolidation/maintenance treatment utilizing low dose interferon alfa or standard dose interferon alfa versus no further treatment in relationship to the duration of event-free survival in these patients.
OUTLINE: This is a randomized, open label, controlled, multicenter study. Patients are randomized into one of two arms for induction chemotherapy. Arm I: Patients receive oral chlorambucil three times daily for 3 consecutive days, oral idarubicin daily for 3 consecutive days, and oral dexamethasone twice daily for 5 consecutive days every 21 days. Arm II: Patients receive oral chlorambucil three times daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days. Treatment for both arms continues for up to 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses of chemotherapy, patients are reassessed. If they have achieved maximal complete response or good partial response, patients are randomized into one of three arms. Arm I: Patients receive no further treatment until disease progresses. Arm II: Patients receive low dose interferon alfa subcutaneously three times per week for a maximum of 3 years in the absence of disease progression. Arm III: Patients receive standard dose interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of disease progression. Patients are followed every 8-12 weeks for 3 years.
PROJECTED ACCRUAL: There will be 200 patients accrued into this study with approximately 150 patients entering the second phase of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| chlorambucil | Drug | – |
| dexamethasone | Drug | – |
| idarubicin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J. Proctor, MD, FRCP, FRCPath study chair
Newcastle-upon-Tyne Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant interferon alfa, chlorambucil and dexamethasone in people with Lymphoma, run by Scotland and Newcastle Lymphoma Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.