LymphomaPhase 3NCT00002576
Combination Chemotherapy in Treating Older Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
A Phase 3 study testing cyclophosphamide, doxorubicin hydrochloride and mitoxantrone hydrochloride in people with Lymphoma, run by Cancer Research Campaign Clinical Trials Centre at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- cyclophosphamide, doxorubicin hydrochloride and mitoxantrone hydrochloride
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 1992to Jan 2001
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS: Histologically confirmed intermediate- or high-grade non- Hodgkin's lymphoma of the following types: Diffuse centroblastic Diffuse immunoblastic B- and T-cell lymphoblastic Peripheral T-cell (mixed or large cell) and Ki-1 No Stage IA (nonbulky) disease suitable for radiotherapy alone
PATIENT CHARACTERISTICS: Age: 65 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe ischemic heart disease No cardiomyopathy that would restrict doxorubicin use Other: No other serious medical conditions that would affect treatment outcome No prior malignancy except: Nonmelanomatous skin cancer Adequately treated in situ cervical cancer Sufficiently fit to receive treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
About this study
Official title: A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES: I. Assess the treatment-related neurologic and hematologic toxicities of patients aged 65 years and over with intermediate- or high-grade non-Hodgkin's lymphoma randomized to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) vs. MCOP (mitoxantrone, cyclophosphamide, vincristine, prednisolone). II. Compare the survival rate in these patients.
OUTLINE: Randomized study. The following acronyms are used: CHOP CTX/DOX/VCR/PRDL CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 MCOP DHAD/CTX/VCR/PRDL PRDL Prednisolone, NSC-9900 VCR Vincristine, NSC-67574 Arm I: 4-Drug Combination Chemotherapy. CHOP. Arm II: 4-Drug Combination Chemotherapy. MCOP.
PROJECTED ACCRUAL: A total of 200 patients will be entered over approximately 5 years.
- Conditions
- Lymphoma
- Being tested
- cyclophosphamide, doxorubicin hydrochloride, mitoxantrone hydrochloride, prednisolone, vincristine sulfate
- Keywords
- stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage II adult diffuse mixed cell lymphoma, stage II adult diffuse large cell lymphoma, stage II adult immunoblastic large cell lymphoma, stage II adult lymphoblastic lymphoma, stage II adult Burkitt lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
mitoxantrone hydrochlorideDrug
prednisoloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2004 (estimated)
- Study startNov 1992
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cancer Research Campaign Clinical Trials Centre
- Sponsor type
- University, hospital or other
- Investigators
- Eric Michael Bessell, MD, PhD, FRCP, FRCR, Study chair, Nottingham City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002576
- Sponsor's protocol ID
- CRC-TU-NH3003
- Other IDs
- CDR0000063660, EU-93028, ISRCTN39268693
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Sattler FR, Mert M, Sankaranarayanan I, Mack WJ, Galle-Treger L, Gonzalez E, Baronikian L, Lee K, Jahani PS, Hodis HN, Dieli-Conwright C, Akbari O. Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity. PLoS One. 2020 Sep 3;15(9):e0237496. doi: 10.1371/journal.pone.0237496. eCollection 2020.
PubMed 32881912
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER)
- ClinicalTrials.gov ID
- NCT00002576
- Acronym / sponsor ID
- CRC-TU-NH3003
- Conditions
- Lymphoma
- Keywords
- stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage II adult diffuse mixed cell lymphoma, stage II adult diffuse large cell lymphoma, stage II adult immunoblastic large cell lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Research Campaign Clinical Trials CentreUniversity, hospital or other
- Study start
- Nov 1992
- Study completion
- Jan 2001 (actual)
- First posted
- 24 May 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 tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of cyclophosphamide, vincristine, and prednisolone, with either mitoxantrone or doxorubicin in treating patients with intermediate- or high-grade non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: I. Assess the treatment-related neurologic and hematologic toxicities of patients aged 65 years and over with intermediate- or high-grade non-Hodgkin's lymphoma randomized to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) vs. MCOP (mitoxantrone, cyclophosphamide, vincristine, prednisolone). II. Compare the survival rate in these patients.
OUTLINE: Randomized study. The following acronyms are used: CHOP CTX/DOX/VCR/PRDL CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 MCOP DHAD/CTX/VCR/PRDL PRDL Prednisolone, NSC-9900 VCR Vincristine, NSC-67574 Arm I: 4-Drug Combination Chemotherapy. CHOP. Arm II: 4-Drug Combination Chemotherapy. MCOP.
PROJECTED ACCRUAL: A total of 200 patients will be entered over approximately 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
| prednisolone | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 32881912Sattler FR, Mert M, Sankaranarayanan I, Mack WJ, Galle-Treger L, Gonzalez E, Baronikian L, Lee K, Jahani PS, Hodis HN, Dieli-Conwright C, Akbari O. Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity. PLoS One. 2020 Sep 3;15(9):e0237496. doi: 10.1371/journal.pone.0237496. eCollection 2020.
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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.
Eric Michael Bessell, MD, PhD, FRCP, FRCR study chair
Nottingham City Hospital
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 cyclophosphamide, doxorubicin hydrochloride and mitoxantrone hydrochloride in people with Lymphoma, run by Cancer Research Campaign Clinical Trials Centre 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: finished, as of the sponsor's last update on 7 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00002576, which also lists 1 linked publication.
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 7 Aug 2013.