Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT00678327 |
Recruitment Status :
Active, not recruiting
First Posted : May 15, 2008
Last Update Posted : May 10, 2023
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RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
Condition or disease | Intervention/treatment | Phase |
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Lymphoma | Biological: bleomycin sulfate Biological: filgrastim Biological: pegfilgrastim Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1202 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma |
Actual Study Start Date : | August 29, 2008 |
Actual Primary Completion Date : | January 31, 2016 |
Estimated Study Completion Date : | May 2023 |
Arm | Intervention/treatment |
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Active Comparator: Arm I
Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
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Biological: bleomycin sulfate
Given IV Drug: dacarbazine Given IV Drug: doxorubicin hydrochloride Given IV Drug: vinblastine sulfate Given IV |
Active Comparator: Arm II
Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
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Drug: dacarbazine
Given IV Drug: doxorubicin hydrochloride Given IV Drug: vinblastine sulfate Given IV |
Experimental: BEACOPP-14 chemotherapy
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
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Biological: bleomycin sulfate
Given IV Biological: filgrastim Given subcutaneously Biological: pegfilgrastim Given subcutaneously Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: prednisolone Given orally Drug: procarbazine hydrochloride Given orally Drug: vincristine sulfate Given IV |
Experimental: BEACOPP-escalated chemotherapy
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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Biological: bleomycin sulfate
Given IV Biological: filgrastim Given subcutaneously Biological: pegfilgrastim Given subcutaneously Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: prednisolone Given orally Drug: procarbazine hydrochloride Given orally Drug: vincristine sulfate Given IV |
- 3-year progression-free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 5 years after last patient recruited ]
- Acute and chronic toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 5 years after last patient recruited ]
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following criteria:
- Meets current WHO classification criteria (i.e., nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte-depleted)
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Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following:
- Bulk mediastinal disease, defined as maximal transverse diameter of mass > 0.33 of the internal thoracic diameter at D5/6 interspace on routine chest x-ray
- Disease outside the mediastinum and lymph node or lymph node mass > 10 cm in diameter
- More than two sites of disease
- Other poor-risk features that require treatment with full course combination chemotherapy
- Newly diagnosed disease
- No CNS or meningeal involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy > 3 months
- ANC > 1,500/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Platelet count > 100,000/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Creatinine < 150% of upper limit of normal (ULN)
- Bilirubin < 2.0 times ULN (unless attributed to lymphoma)
- Transaminases < 2.5 times ULN (unless attributed to lymphoma)
- LVEF ≥ 50% (in patients with a significant history of ischemic heart disease or hypertension)
- Diffusion capacity within 25% of normal predicted value by lung function testing
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Amenable to the administration of a full course of chemotherapy, according to the investigator
- Must have access to PET/CT scanning
- No poorly controlled diabetes mellitus
- No cardiac contraindication to doxorubicin hydrochloride, including abnormal contractility by ECHO or MUGA
- No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy)
- No other concurrent uncontrolled medical condition
- No other active malignant disease within the past 10 years, except fully excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
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No known positivity for HIV, hepatitis B surface antigen, or hepatitis C
- Routine testing, in the absence of risk factors, is not required
- No medical or psychiatric condition that compromises the patient's ability to give informed consent
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy or other investigational drug for HL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678327
United Kingdom | |
Southampton General Hospital | |
Southampton, England, United Kingdom, SO16 6YD |
Principal Investigator: | Peter Johnson, MD | University Hospital Southampton NHS Foundation Trust |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT00678327 |
Other Study ID Numbers: |
CDR0000593562 CRUK-2007-006064-30 CRUK-07/146 |
First Posted: | May 15, 2008 Key Record Dates |
Last Update Posted: | May 10, 2023 |
Last Verified: | May 2023 |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone Cyclophosphamide Dacarbazine Doxorubicin Liposomal doxorubicin Etoposide Vincristine |
Bleomycin Vinblastine Procarbazine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |