Non-Hodgkin's LymphomaPhase 2NCT00809341
R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Non-Hodgkin's Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide and Doxorubicin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma
- Diffuse large B-cell lymphoma
- Mediastinal (thymic) B-cell lymphoma
- Any stage (I through IV) as defined by the Ann Arbor staging system
- ECOG performance status of 0 to 2
- Radiographically measurable disease
Show all 12Show fewer
- No more than 3 cycles of chemotherapy for lymphoma
- Greater than or equal to 18 years
- Adequate pulmonary, cardiac, hepatic, or renal function
- HIV antibody negative
- Women- Not pregnant or breastfeeding
- Men of reproductive potential must agree to use contraception
Who cannot join
- Patients with the following aggressive lymphomas are not eligible:
- Mantle cell
- Lymphoblastic
- Burkitt's
- Mycosis fungoides/Sezary's syndrome
- HTLV-1 associated T-cell leukemia/lymphoma
Show all 14Show fewer
- Primary CNS lymphoma
- HIV-associated lymphoma
- Transformed lymphomas
- Immunodeficiency-associated lymphomas
- Previous diagnosis of another hematologic malignancies
- Progressive disease on CHOP or Rituximab-CHOP
- Active CNS involvement by lymphoma
- Serious co-morbid disease that could preclude full participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.
The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.
Read more
We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.
The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.
Read the detailed description
Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT. Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be designated as negative or positive. Based on the results, patients will either complete standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide and rituximab.
A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Keywords
- B-Cell, non-Hodgkin's, Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Also called Rituxan
375 mg/m^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m^2 on Days 1, 30, and 37 as part of HiCy.
CyclophosphamideDrug
Also called Cytoxan
750 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
DoxorubicinDrug
Also called Adriamycin, Hydroxydaunorubicin
50 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
VincristineDrug
Also called Oncovin
1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP.
PrednisoneDrug
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
IfosfamideDrug
Also called Ifex
2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
CarboplatinDrug
Also called Paraplatin
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
EtoposideDrug
Also called VP-16
100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP.
High-dose cyclophosphamideDrug
Also called HiCy
50 mg/kg/day on Days 2-5 of HiCy.
PET scanProcedure or surgery
Also called FDG-PET
Performed once between Days 16-20 of cycle 3 of R-CHOP.
| Study group | Role | What they receive |
|---|---|---|
| PET Negative | Active comparator | R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist. Receives: Biological: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Procedure: PET scan |
| PET Positive | Active comparator | R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide). Receives: Biological: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: High-dose cyclophosphamide; Procedure: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
Measured: 2 years
Secondary outcomes (1)
Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Lode Swinnen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809341
- Sponsor's protocol ID
- J0802
- Other IDs
- NA_00013656, J0802
- Status last verified
- Sep 2018
- First submitted
- 16 Dec 2008
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning
- ClinicalTrials.gov ID
- NCT00809341
- Acronym / sponsor ID
- J0802
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- B-Cell, non-Hodgkin's, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.
The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.
We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.
The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.
Detailed description
Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT. Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be designated as negative or positive. Based on the results, patients will either complete standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide and rituximab.
A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET Negative | Active comparator | Biological: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Procedure: PET scanR-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist. |
| PET Positive | Active comparator | Biological: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Ifosfamide, Drug: Carboplatin, Drug: Etoposide, Drug: High-dose cyclophosphamide, Procedure: PET scanR-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma
- Any stage (I through IV) as defined by the Ann Arbor staging system
- ECOG performance status of 0 to 2
- Radiographically measurable disease
- No more than 3 cycles of chemotherapy for lymphoma
Key exclusion criteria (14 listed)
- Patients with the following aggressive lymphomas are not eligible:
- Previous diagnosis of another hematologic malignancies
- Progressive disease on CHOP or Rituximab-CHOP
- Active CNS involvement by lymphoma
- Serious co-morbid disease that could preclude full participation in study
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 |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m^2 on Days 1, 30, and 37 as part of HiCy. | Biological | PET Negative, PET Positive |
| CyclophosphamideAlso: Cytoxan750 mg/m^2 on Day 1 of each cycle as part of R-CHOP. | Drug | PET Negative, PET Positive |
| DoxorubicinAlso: Adriamycin, Hydroxydaunorubicin50 mg/m^2 on Day 1 of each cycle as part of R-CHOP. | Drug | PET Negative, PET Positive |
| VincristineAlso: Oncovin1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP. | Drug | PET Negative, PET Positive |
| Prednisone100 mg/day on Days 1-5 of each cycle as part of R-CHOP. | Drug | PET Negative, PET Positive |
| IfosfamideAlso: Ifex2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP. | Drug | PET Positive |
| CarboplatinAlso: ParaplatinGiven on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function. | Drug | PET Positive |
| EtoposideAlso: VP-16100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP. | Drug | PET Positive |
| High-dose cyclophosphamideAlso: HiCy50 mg/kg/day on Days 2-5 of HiCy. | Drug | PET Positive |
| PET scanAlso: FDG-PETPerformed once between Days 16-20 of cycle 3 of R-CHOP. | Procedure or surgery | PET Negative, PET Positive |
Primary outcome
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
Time frame: 2 years
1 secondary outcome
Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lode Swinnen, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Non-Hodgkin's Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. 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: stopped early, as of the sponsor's last update on 25 Sep 2018. 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 States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 25 Sep 2018.