LymphomaPhase 2NCT01390584
Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
A Phase 2 study testing Doxorubicin, Bleomycin and Vinblastine in people with Lymphoma, run by ECOG-ACRIN Cancer Research Group at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Doxorubicin, Bleomycin and Vinblastine
- 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
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2013to 18 May 2018
- 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
- Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)
- Patients must have clinical stage IA, IB, IIA, or IIB disease
- Patients with "E" extensions will be eligible if all other criteria have been met
- Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images
- Bone marrow biopsy is required
- ECOG performance status 0-2
Show all 20Show fewer
- ANC ≥ 1,000/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 2 mg/dL
- Direct bilirubin ≤ 2 mg/dL
- AST/ALT ≤ 2 times upper limit of normal
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- LVEF by ECHO or MUGA normal unless thought to be disease related
- DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related
- Patients with a history of intravenous drug abuse, or any behavior associated with an increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol
- HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on concurrent antiretrovirals
- Patient HIV status must be known prior to registration
- HIV-positive patients must not have multi-drug resistant HIV infections; CD4 counts < 400/mm³; or other concurrent AIDS-defining conditions
- Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed
Who cannot join
- Nodular lymphocyte-predominant Hodgkin lymphoma
- Pregnant or nursing
- "Currently active" second malignancy other than non-melanoma skin cancers
- Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
- Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Stanford Cancer Center
Stanford, California, 94305-5824
About this study
Official title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the progression-free survival (PFS) at 36 months following registration for patients who are positron emission tomography (PET) negative after 2 courses of ABVD, and receive 4 additional courses of doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) followed by involved-nodal radiotherapy [INRT] of 30-30.6 Gy.
Secondary
- To evaluate the PET-negative rate after 2 courses of ABVD chemotherapy in patients with stage I/II Hodgkin lymphoma with bulky mediastinal disease.
- To evaluate the PFS at 36 months for patients who are PET positive after 2 courses of chemotherapy and receive 4 courses of escalated bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, procarbazine hydrochloride, and prednisone (BEACOPP) followed by INRT of 30-30.6 Gy.
- To evaluate the complete response (CR) rate and overall survival (OS) for PET-positive and PET-negative patients after 2 courses of ABVD.
- To identify sites of relapse following combined-modality therapy (CMT) for patients with large mediastinal adenopathy and correlate with RT fields.
- To assess toxicity on both arms of study.
- To assess reproductive function at baseline and at 3 years after ABVD or escalated BEACOPP with specific serum markers.
- To bank serum and plasma at baseline and selected time points to assess the prognostic value of various markers such as, but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.
- To create tissue microarrays (TMAs) from patient tumor blocks for future biomarker assessment including, but not limited to, bcl-2, FOXP3, and macrophage content.
- To measure serum TARC levels pre-treatment and post two courses of ABVD and correlate with PET-CT findings (performed at same time points) and 3 year PFS.
Tertiary
- To assess the predictive value of fludeoxyglucose F 18 (18FDG) uptake, as measured by semi-quantitative measurements including standard uptake variables (SUVs), with respect to response at the end of chemotherapy and PFS.
- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with CT size change information.
- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with available serum and tissue molecular biomarkers.
- To compare the results of the secondary imaging objectives with the corresponding CALGB 50801 results (contingent on reaching agreement with CALGB on the combined analysis of the two studies).
OUTLINE: This is a multicenter study.
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are then assigned to an intervention arm according to fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT) results (negative vs positive).
- ABVD (18FDG-PET/CT negative): Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
- Escalated or standard BEACOPP* (18FDG-PET/CT positive): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
NOTE: *HIV-positive patients whose 18FDG-PET/CT scans are positive after two courses of induction ABVD receive 4 courses of standard BEACOPP followed by INRT.
Patients undergo 18FDG-PET scans at baseline, and within 8-10 days after 2 courses of ABVD induction chemotherapy. Patients also undergo 18FDG-PET/CT** scan within 3-8 weeks after completion of 4 courses of BEACOPP and 6 courses of ABVD, and 3 months after completion of INRT.
NOTE: **If PET/CT remains positive, then a biopsy may be performed if medically appropriate or clinically feasible at the discretion of the treating physician. If biopsy is positive, patients will be followed for survival and secondary malignancies or new primaries.
Patients may undergo blood sample collection for correlative studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.
- Conditions
- Lymphoma
- Being tested
- Doxorubicin, Bleomycin, Vinblastine, PET, INRT
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin R, Rubex R, Adriamycin RDF R, Adriamycin PFS R
IV
BleomycinDrug
Also called Blenoxane R, BLM, Bleo
IV
VinblastineDrug
Also called Velban R, vinblastine sulfate, vincaleukoblastine, VLB
IV
PETDiagnostic test
Also called PET/CT
fludeoxyglucose F 18 Imaging exam
INRTRadiation
selective external radiation therapy
DacarbazineDrug
Also called DTIC, DTIC-Dome®, DIC, imidazole carboxamide
IV
EtoposideDrug
Also called VP-16, VePesidÒ, VP-16-213, EPEG
IV
CyclophosphamideDrug
Also called CytoxanÒ, NeosarÒ, CTX, CPM
May be given orally, IV push, or by IV infusion
VincristineDrug
Also called Oncovin R, Vincasar PFS R, vincristine sulfate, VCR
IV
ProcarbazineDrug
Also called MatulaneR, Ibenzmethyzin, Natulanar, N-Methylhydrazine
PO
PrednisoneDrug
Also called Deltasone, Orasone, Medicorten, Panasol-S
PO
| Study group | Role | What they receive |
|---|---|---|
| ABVD + INRT | Experimental | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.
ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. Receives: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Diagnostic Test: PET; Radiation: INRT; Drug: Dacarbazine |
| ABVD + BEACOPP + INRT | Experimental | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.
BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. Receives: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Diagnostic Test: PET; Radiation: INRT; Drug: Dacarbazine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Measured: Assessed at 36 months
Secondary outcomes (8)
Proportion of Patients Who Are PET Negative After Induction Treatment
Measured: Assessed at end of Cycle 2
Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Measured: Assessed at 36 months
Complete Response (CR) Rate After Induction Treatment
Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
Measured: Assessed at end of Cycle 2
Overall Survival
Overall survival is defined as the time from study entry to death or date last known alive.
Measured: Assessed at 36 months
Sites of Relapse Following Combined Modality Treatment
Measured: Assessed at 3, 12, 18, 24 and 36 months after INRT
Serum and Plasma Banking
To bank serum and plasma at baseline and follow-up time point to assess the prognostic value of various markers, such as but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.
Measured: Baseline and post cycle 2
Biomarker Assessment Using Tissue Microarrays (TMAs)
To create TMAs from patient tumor blocks for future biomarker assessment including but not limited to bcl-2, FOXP3, and macrophage content.
Measured: Baseline and relapse/progression
The Association Between Thymus and Activation-related Chemokine (TARC) Levels and PET-CT Findings as Well as 3-year PFS
To measure serum TARC levels pre-treatment and after two cycles of ABVD and evaluate the associations between TARC levels and PET-CT findings as well as 3-year PFS.
Measured: Baseline and cycle 2 for TARC assessments; 3 years for PFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study start24 May 2013
- Primary completion9 Apr 2015
- Study completion18 May 2018
Why it stopped: slow 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 LymphomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ranjana Advani, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390584
- Sponsor's protocol ID
- E2410
- Other IDs
- NCT01390584, U01CA079778, U01CA080098
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2011
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)
- ClinicalTrials.gov ID
- NCT01390584
- Acronym / sponsor ID
- E2410
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 May 2013 (actual)
- Primary completion
- 9 Apr 2015 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 22 Dec 2020
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, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.
Detailed description
OBJECTIVES:
Primary
- To evaluate the progression-free survival (PFS) at 36 months following registration for patients who are positron emission tomography (PET) negative after 2 courses of ABVD, and receive 4 additional courses of doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) followed by involved-nodal radiotherapy [INRT] of 30-30.6 Gy.
Secondary
- To evaluate the PET-negative rate after 2 courses of ABVD chemotherapy in patients with stage I/II Hodgkin lymphoma with bulky mediastinal disease.
- To evaluate the PFS at 36 months for patients who are PET positive after 2 courses of chemotherapy and receive 4 courses of escalated bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, procarbazine hydrochloride, and prednisone (BEACOPP) followed by INRT of 30-30.6 Gy.
- To evaluate the complete response (CR) rate and overall survival (OS) for PET-positive and PET-negative patients after 2 courses of ABVD.
- To identify sites of relapse following combined-modality therapy (CMT) for patients with large mediastinal adenopathy and correlate with RT fields.
- To assess toxicity on both arms of study.
- To assess reproductive function at baseline and at 3 years after ABVD or escalated BEACOPP with specific serum markers.
- To bank serum and plasma at baseline and selected time points to assess the prognostic value of various markers such as, but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.
- To create tissue microarrays (TMAs) from patient tumor blocks for future biomarker assessment including, but not limited to, bcl-2, FOXP3, and macrophage content.
- To measure serum TARC levels pre-treatment and post two courses of ABVD and correlate with PET-CT findings (performed at same time points) and 3 year PFS.
Tertiary
- To assess the predictive value of fludeoxyglucose F 18 (18FDG) uptake, as measured by semi-quantitative measurements including standard uptake variables (SUVs), with respect to response at the end of chemotherapy and PFS.
- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with CT size change information.
- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG uptake in combination with available serum and tissue molecular biomarkers.
- To compare the results of the secondary imaging objectives with the corresponding CALGB 50801 results (contingent on reaching agreement with CALGB on the combined analysis of the two studies).
OUTLINE: This is a multicenter study.
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are then assigned to an intervention arm according to fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT) results (negative vs positive).
- ABVD (18FDG-PET/CT negative): Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.
- Escalated or standard BEACOPP* (18FDG-PET/CT positive): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks.
NOTE: *HIV-positive patients whose 18FDG-PET/CT scans are positive after two courses of induction ABVD receive 4 courses of standard BEACOPP followed by INRT.
Patients undergo 18FDG-PET scans at baseline, and within 8-10 days after 2 courses of ABVD induction chemotherapy. Patients also undergo 18FDG-PET/CT** scan within 3-8 weeks after completion of 4 courses of BEACOPP and 6 courses of ABVD, and 3 months after completion of INRT.
NOTE: **If PET/CT remains positive, then a biopsy may be performed if medically appropriate or clinically feasible at the discretion of the treating physician. If biopsy is positive, patients will be followed for survival and secondary malignancies or new primaries.
Patients may undergo blood sample collection for correlative studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABVD + INRT | Experimental | Drug: Doxorubicin, Drug: Bleomycin, Drug: Vinblastine, Diagnostic Test: PET, Radiation: INRT, Drug: DacarbazineInduction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment. ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. |
| ABVD + BEACOPP + INRT | Experimental | Drug: Doxorubicin, Drug: Bleomycin, Drug: Vinblastine, Diagnostic Test: PET, Radiation: INRT, Drug: Dacarbazine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Procarbazine, Drug: PrednisoneInduction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment. BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)
- Patients must have clinical stage IA, IB, IIA, or IIB disease
- Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images
- Bone marrow biopsy is required
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- Nodular lymphocyte-predominant Hodgkin lymphoma
- Pregnant or nursing
- "Currently active" second malignancy other than non-melanoma skin cancers
- Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
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 |
|---|---|---|
| DoxorubicinAlso: Adriamycin R, Rubex R, Adriamycin RDF R, Adriamycin PFS RIV | Drug | ABVD + BEACOPP + INRT, ABVD + INRT |
| BleomycinAlso: Blenoxane R, BLM, BleoIV | Drug | ABVD + BEACOPP + INRT, ABVD + INRT |
| VinblastineAlso: Velban R, vinblastine sulfate, vincaleukoblastine, VLBIV | Drug | ABVD + BEACOPP + INRT, ABVD + INRT |
| PETAlso: PET/CTfludeoxyglucose F 18 Imaging exam | Diagnostic test | ABVD + BEACOPP + INRT, ABVD + INRT |
| INRTselective external radiation therapy | Radiation | ABVD + BEACOPP + INRT, ABVD + INRT |
| DacarbazineAlso: DTIC, DTIC-Dome®, DIC, imidazole carboxamideIV | Drug | ABVD + BEACOPP + INRT, ABVD + INRT |
| EtoposideAlso: VP-16, VePesidÒ, VP-16-213, EPEGIV | Drug | ABVD + BEACOPP + INRT |
| CyclophosphamideAlso: CytoxanÒ, NeosarÒ, CTX, CPMMay be given orally, IV push, or by IV infusion | Drug | ABVD + BEACOPP + INRT |
| VincristineAlso: Oncovin R, Vincasar PFS R, vincristine sulfate, VCRIV | Drug | ABVD + BEACOPP + INRT |
| ProcarbazineAlso: MatulaneR, Ibenzmethyzin, Natulanar, N-MethylhydrazinePO | Drug | ABVD + BEACOPP + INRT |
| PrednisoneAlso: Deltasone, Orasone, Medicorten, Panasol-SPO | Drug | ABVD + BEACOPP + INRT |
Primary outcome
Progression-free Survival Rate
Time frame: Assessed at 36 months
Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
8 secondary outcomes
Proportion of Patients Who Are PET Negative After Induction Treatment
Time frame: Assessed at end of Cycle 2
Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
Time frame: Assessed at 36 months
Complete Response (CR) Rate After Induction Treatment
Time frame: Assessed at end of Cycle 2
Overall Survival
Time frame: Assessed at 36 months
Sites of Relapse Following Combined Modality Treatment
Time frame: Assessed at 3, 12, 18, 24 and 36 months after INRT
Serum and Plasma Banking
Time frame: Baseline and post cycle 2
Biomarker Assessment Using Tissue Microarrays (TMAs)
Time frame: Baseline and relapse/progression
The Association Between Thymus and Activation-related Chemokine (TARC) Levels and PET-CT Findings as Well as 3-year PFS
Time frame: Baseline and cycle 2 for TARC assessments; 3 years for PFS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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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.
Ranjana Advani, MD study chair
Stanford University
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 Doxorubicin, Bleomycin and Vinblastine in people with Lymphoma, run by ECOG-ACRIN Cancer Research Group 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 20 inclusion and 5 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 29 Jun 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 22 Dec 2020). 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?
Progression-free Survival Rate (time frame: Assessed at 36 months). 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 29 Jun 2023.