LymphomaPhase 3NCT00002565
Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma
A Phase 3 study testing bleomycin sulfate, CHOP regimen and cisplatin in people with Lymphoma, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, CHOP regimen and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 May 1994to 5 Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Previously untreated non-Hodgkin's lymphoma (NHL) of one of the following histologies: Diffuse large cell Follicular large non-cleaved cell Diffuse mixed cell Immunoblastic At least 2 of the following poor-prognosis factors required: Age over 60 Performance status greater than 1 Any elevation of LDH More than 1 extranodal site Ann Arbor stage III or IV T- and B-cell NHL eligible if meeting all above criteria No primary CNS lymphoma Brain involvement eligible if not primary
PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Any status Hematopoietic: (unless secondary to tumor) Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Elevation secondary to tumor discussed with study chairman Renal: (unless secondary to tumor) Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 55% by echocardiography Pulmonary: No chronic obstructive or restrictive lung disease Pulmonary consultation required in cases of doubt Other: No HIV infection No prior malignancy with less than a 90% 5-year survival probability No patients unable or unlikely to adhere to treatment because of geographic, economic, emotional, or social factors No unwillingness to accept blood product transfusions or other supportive measures (e.g., antibiotics)
PRIOR CONCURRENT THERAPY: No prior therapy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) versus the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide).
II. Compare the complete response rate achieved with ATT versus standard CHOP.
III. Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support.
IV. Compare the predictive capability of the M.D. Anderson Tumor Score System versus the International Index System.
OUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540
Arm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.
Arm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED.
PROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to this multicenter study. If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures, consideration will be given to early closure.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, CHOP regimen, cisplatin, cyclophosphamide, cytarabine
- Keywords
- stage I grade 3 follicular lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage II grade 3 follicular lymphoma, stage II adult diffuse mixed cell lymphoma, stage II adult diffuse large cell lymphoma, stage II adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
CHOP regimenDrug
cisplatinDrug
cyclophosphamideDrug
cytarabineDrug
etoposideDrug
idarubicinDrug
ifosfamideDrug
mesnaDrug
mitoxantrone hydrochlorideDrug
prednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.
Alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide). Receives: Biological: bleomycin sulfate; Drug: cisplatin; Drug: cyclophosphamide; Drug: cytarabine; Drug: etoposide; Drug: idarubicin; Drug: ifosfamide; Drug: mesna; Drug: methylprednisolone; Drug: mitoxantrone hydrochloride; Drug: vincristine sulfate |
| Arm II | Experimental | 4-Drug Combination Chemotherapy. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone): CTX/DOX/VCR/PRED. Receives: Drug: CHOP regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2004 (estimated)
- Study start25 May 1994
- Primary completion5 Feb 2007
- Study completion5 Feb 2007
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Fernando Cabanillas, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002565
- Sponsor's protocol ID
- CDR0000063574
- Other IDs
- MDA-DM-94017, NCI-T94-0040D, DM94-017
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 1999
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
- ClinicalTrials.gov ID
- NCT00002565
- Acronym / sponsor ID
- CDR0000063574
- Conditions
- Lymphoma
- Keywords
- stage I grade 3 follicular lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage II grade 3 follicular 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
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 May 1994 (actual)
- Primary completion
- 5 Feb 2007 (actual)
- Study completion
- 5 Feb 2007 (actual)
- First posted
- 30 Jun 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. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) versus the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide).
II. Compare the complete response rate achieved with ATT versus standard CHOP.
III. Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support.
IV. Compare the predictive capability of the M.D. Anderson Tumor Score System versus the International Index System.
OUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540
Arm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16.
Arm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED.
PROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to this multicenter study. If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures, consideration will be given to early closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: bleomycin sulfate, Drug: cisplatin, Drug: cyclophosphamide, Drug: cytarabine, Drug: etoposide, Drug: idarubicin, Drug: ifosfamide, Drug: mesna, Drug: methylprednisolone, Drug: mitoxantrone hydrochloride, Drug: vincristine sulfateSequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16. Alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide). |
| Arm II | Experimental | Drug: CHOP regimen, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisone, Drug: vincristine sulfate4-Drug Combination Chemotherapy. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone): CTX/DOX/VCR/PRED. |
Who may qualify
- Ages
- 15 years and older
- 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 |
|---|---|---|
| bleomycin sulfate | Biological | Arm I |
| CHOP regimen | Drug | Arm II |
| cisplatin | Drug | Arm I |
| cyclophosphamide | Drug | Arm I, Arm II |
| cytarabine | Drug | Arm I |
| doxorubicin hydrochloride | Drug | Arm II |
| etoposide | Drug | Arm I |
| idarubicin | Drug | Arm I |
| ifosfamide | Drug | Arm I |
| mesna | Drug | Arm I |
| methylprednisolone | Drug | Arm I |
| mitoxantrone hydrochloride | Drug | Arm I |
| prednisone | Drug | Arm II |
| vincristine sulfate | Drug | Arm I, Arm II |
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 14 Nov 2018.
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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.
Fernando Cabanillas, MD study chair
M.D. Anderson Cancer Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, CHOP regimen and cisplatin in people with Lymphoma, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Brazil, Chile. 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?
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 14 Nov 2018.