T-cell Non-Hodgkin LymphomaPhase 2NCT01746173
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
A Phase 2 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with T-cell Non-Hodgkin Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T-cell Non-Hodgkin Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin and Vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital
- Measurable disease
- Candidate for Autologous Stem Cell Transplant
Who cannot join
- Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP)
- Pregnant or breastfeeding
- Alk-positive ACL
- Significant neuropathy precluding vincristine administration
- Known hypersensitivity to any of the agents used in the treatment
- Uncontrolled intercurrent illness
Show all 9Show fewer
- Receiving other investigational agents
- History of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin
- HIV positive on anti-retroviral therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.
Read the detailed description
Objectives:
Primary
- To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy
Secondary
- To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT
- To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM)
- To estimate the toxicity (grade 3 and above)
- To estimate the rate of successful stem cell mobilization after CHOEP in responding patients
- To estimate the proportion of patients who can successfully complete the entire treatment regimen
- To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
- To determine whether tumor DNA can be detected in peripheral blood of patients before therapy
- To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT
- Conditions
- T-cell Non-Hodgkin Lymphoma
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, Prednisone
- Keywords
- T Cell lymphoma
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called cytoxan
DoxorubicinDrug
Also called adriamycin
VincristineDrug
Also called oncovin
EtoposideDrug
Also called Etopophos, Toposar, Etoposide phosphate
PrednisoneDrug
FilgrastimDrug
Also called neupogen, G-CSF
PlerixaforDrug
Also called mozobil
Stem Cell CollectionProcedure or surgery
Also called Leukapheresis
PaliferminDrug
Also called KGF, kepivance
GemcitabineDrug
Also called gemzar
BusulfanDrug
Also called busulfex
MelphalanDrug
Stem Cell TransplantProcedure or surgery
Also called Stem Cell Infusion
| Study group | Role | What they receive |
|---|---|---|
| CHOEP + High Dose Therapy + Auto SCT | Experimental | Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol). Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Etoposide; Drug: Prednisone; Drug: Filgrastim; Drug: Plerixafor; Procedure: Stem Cell Collection; Drug: Palifermin; Drug: Gemcitabine; Drug: Busulfan; Drug: Melphalan; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-month Progression-Free Survival Rate
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).
Measured: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
Secondary outcomes (1)
Induction Response
Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.
Measured: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Slow accrual and futility
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 T-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Philippe Armand, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746173
- Sponsor's protocol ID
- 12-388
- Status last verified
- Jan 2023
- First submitted
- 4 Dec 2012
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01746173
- Acronym / sponsor ID
- 12-388
- Conditions
- T-cell Non-Hodgkin Lymphoma
- Keywords
- T Cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and futility
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.
Detailed description
Objectives:
Primary
- To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy
Secondary
- To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT
- To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM)
- To estimate the toxicity (grade 3 and above)
- To estimate the rate of successful stem cell mobilization after CHOEP in responding patients
- To estimate the proportion of patients who can successfully complete the entire treatment regimen
- To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
- To determine whether tumor DNA can be detected in peripheral blood of patients before therapy
- To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHOEP + High Dose Therapy + Auto SCT | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Etoposide, Drug: Prednisone, Drug: Filgrastim, Drug: Plerixafor, Procedure: Stem Cell Collection, Drug: Palifermin, Drug: Gemcitabine, Drug: Busulfan, Drug: Melphalan, Procedure: Stem Cell TransplantPatients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital
- Measurable disease
- Candidate for Autologous Stem Cell Transplant
Key exclusion criteria (9 listed)
- Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP)
- Pregnant or breastfeeding
- Alk-positive ACL
- Significant neuropathy precluding vincristine administration
- Known hypersensitivity to any of the agents used in the treatment
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 |
|---|---|---|
| CyclophosphamideAlso: cytoxan | Drug | CHOEP + High Dose Therapy + Auto SCT |
| DoxorubicinAlso: adriamycin | Drug | CHOEP + High Dose Therapy + Auto SCT |
| VincristineAlso: oncovin | Drug | CHOEP + High Dose Therapy + Auto SCT |
| EtoposideAlso: Etopophos, Toposar, Etoposide phosphate | Drug | CHOEP + High Dose Therapy + Auto SCT |
| Prednisone | Drug | CHOEP + High Dose Therapy + Auto SCT |
| FilgrastimAlso: neupogen, G-CSF | Drug | CHOEP + High Dose Therapy + Auto SCT |
| PlerixaforAlso: mozobil | Drug | CHOEP + High Dose Therapy + Auto SCT |
| Stem Cell CollectionAlso: Leukapheresis | Procedure or surgery | CHOEP + High Dose Therapy + Auto SCT |
| PaliferminAlso: KGF, kepivance | Drug | CHOEP + High Dose Therapy + Auto SCT |
| GemcitabineAlso: gemzar | Drug | CHOEP + High Dose Therapy + Auto SCT |
| BusulfanAlso: busulfex | Drug | CHOEP + High Dose Therapy + Auto SCT |
| Melphalan | Drug | CHOEP + High Dose Therapy + Auto SCT |
| Stem Cell TransplantAlso: Stem Cell Infusion | Procedure or surgery | CHOEP + High Dose Therapy + Auto SCT |
Primary outcome
24-month Progression-Free Survival Rate
Time frame: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).
1 secondary outcome
Induction Response
Time frame: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Philippe Armand, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with T-cell Non-Hodgkin Lymphoma, run by Dana-Farber Cancer Institute at 2 sites 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 3 inclusion and 9 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 11 Jan 2017). 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?
24-month Progression-Free Survival Rate (time frame: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.). 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 30 Jan 2023.