A Phase 2 interventional study of bleomycin sulfate and filgrastim in Lymphoma and Nonneoplastic Condition, sponsored by SWOG Cancer Research Network. Completed at 423 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens:
Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan.
Some patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy.
After completion of study treatment, patients are followed up periodically for 7 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 371 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
Must have known HIV status
Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days
PATIENT CHARACTERISTICS:
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
PRIOR CONCURRENT THERAPY:
Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles
Biological: bleomycin sulfate · Drug: BEACOPP regimen · Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: etoposide · Drug: prednisone · Drug: procarbazine hydrochloride · Drug: vincristine sulfate
Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles
Biological: bleomycin sulfate · Biological: filgrastim · Drug: BEACOPP regimen · Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: etoposide · Drug: prednisone · Drug: procarbazine hydrochloride · Drug: vincristine sulfate
Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2
Biological: bleomycin sulfate · Drug: ABVD regimen · Drug: dacarbazine · Drug: doxorubicin hydrochloride · Drug: vinblastine sulfate
Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2
Biological: bleomycin sulfate · Drug: ABVD regimen · Drug: dacarbazine · Drug: doxorubicin hydrochloride · Drug: vinblastine sulfate
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time frame: 2 years
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: 7 months after registration
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Up to 1 year
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: 2 years
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time frame: 5 years
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: 7 months after registration
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Up to 1 year
| Milestone | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | HIV-negative and PET-negative: Continued ABVD | HIV-negative and PET-positive: BEACOPP Escalated | HIV-positive and PET-negative: Continued ABVD | HIV-positive and PET-positive: BEACOPP Standard |
|---|---|---|---|---|---|---|
| Started | 358 | 13 | 0 | 0 | 0 | 0 |
| Eligible and evaluable patients | 336 | 12 | 0 | 0 | 0 | 0 |
| Completed | 332 | 12 | 0 | 0 | 0 | 0 |
| Not completed | 26 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Refusal unrelated to adverse event | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Reasons not protocol specified | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligible | 22 | 1 | 0 | 0 | 0 | 0 |
| Milestone | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | HIV-negative and PET-negative: Continued ABVD | HIV-negative and PET-positive: BEACOPP Escalated | HIV-positive and PET-negative: Continued ABVD | HIV-positive and PET-positive: BEACOPP Standard |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 270 | 55 | 10 | 1 |
| Eligibile and evaluable patients | 0 | 0 | 270 | 55 | 10 | 1 |
| Completed | 0 | 0 | 270 | 45 | 10 | 1 |
| Not completed | 0 | 0 | 0 | 10 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Refusal unrelated to adverse event | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 6 | 0 | 0 |
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
| percentage of participants | HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap |
|---|---|
| Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 79 (74 to 83) |
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
| percentage of participants | HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP |
|---|---|
| Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS | 64 (50 to 75) |
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
| percentage of participants | HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy |
|---|---|
| Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging | 98 (95 to 99) |
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
| percentage of patients | PET-negative: Continued ABVD After 2 Cycles of ABVD | PET-positive: BEACOPP Escalated After 2 Cycles of ABVD |
|---|---|---|
| Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD | 100 (98.6 to 100) | 93 (82.4 to 97.9) |
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
| Participants | HIV-negative: Initial ABVD | HIV-negative and PET-negative: Continued ABVD | HIV-negative and PET-positive: BEACOPP Escalated |
|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | 3 | 0 | 0 |
| AST, SGOT | 1 | 0 | 0 |
| Adult respiratory distress syndrome (ARDS) | 0 | 2 | 0 |
| Albumin, serum-low (hypoalbuminemia) | 1 | 0 | 0 |
| Alkaline phosphatase | 1 | 0 | 0 |
| Allergic reaction/hypersensitivity | 2 | 2 | 0 |
| Anorexia | 1 | 1 | 0 |
| Arthritis (non-septic) | 1 | 0 | 0 |
| Carbon monoxide diffusion capacity (DL(co)) | 0 | 2 | 0 |
| Colitis | 0 | 1 | 0 |
| Colitis, infectious (e.g., Clostridium difficile) | 1 | 0 | 1 |
| Constipation | 1 | 0 | 0 |
| Cough | 0 | 1 | 0 |
| Creatinine | 0 | 0 | 1 |
| Cytokine release syndrome/acute infusion reaction | 1 | 0 | 0 |
| Dehydration | 1 | 2 | 1 |
| Diarrhea | 0 | 1 | 0 |
| Dizziness | 1 | 0 | 1 |
| Dyspnea (shortness of breath) | 4 | 9 | 1 |
| FEV(1) | 0 | 1 | 0 |
| Fatigue (asthenia, lethargy, malaise) | 10 | 15 | 3 |
| Febrile neutropenia | 8 | 17 | 17 |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | 0 | 3 | 1 |
| Glucose, serum-high (hyperglycemia) | 0 | 1 | 1 |
| Heartburn/dyspepsia | 1 | 0 | 0 |
| Hemoglobin | 10 | 4 | 37 |
| Hemolysis | 0 | 0 | 1 |
| Hemorrhage, pulmonary/upper respiratory - Nose | 0 | 0 | 1 |
| Hypotension | 0 | 0 | 1 |
| Hypoxia | 0 | 3 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 2 | 1 | 2 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 | 0 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 | 4 | 2 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Meninges | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 | 1 | 3 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue | 0 | 1 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 | 1 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 0 | 1 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Vagina | 1 | 0 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 1 | 0 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 | 3 | 0 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 0 | 0 | 1 |
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 | 0 | 1 |
| Infection with normal ANC or Grade 1 or 2 neutroph | 1 | 0 | 0 |
| Infection with unknown ANC - Lung (pneumonia) | 0 | 1 | 0 |
| Left ventricular systolic dysfunction | 0 | 1 | 0 |
| Leukocytes (total WBC) | 73 | 86 | 42 |
| Lymphopenia | 15 | 30 | 32 |
| Metabolic/Laboratory-Other (Specify) | 1 | 0 | 0 |
| Mood alteration - agitation | 1 | 0 | 0 |
| Mood alteration - anxiety | 1 | 0 | 0 |
| Mood alteration - depression | 1 | 0 | 0 |
| Mucositis/stomatitis (clinical exam) - Oral cavity | 1 | 0 | 2 |
| Mucositis/stomatitis (functional/symp) - Oral cav | 1 | 0 | 1 |
| Muscle weakness, not d/t neuropathy - body/general | 0 | 0 | 1 |
| Musculoskeletal/Soft Tissue-Other (Specify) | 0 | 1 | 0 |
| Nausea | 7 | 5 | 2 |
| Neuropathy: motor | 2 | 3 | 0 |
| Neuropathy: sensory | 4 | 12 | 4 |
| Neutrophils/granulocytes (ANC/AGC) | 206 | 165 | 38 |
| Osteonecrosis (avascular necrosis) | 0 | 0 | 1 |
| Pain - Abdomen NOS | 2 | 5 | 1 |
| Pain - Back | 1 | 0 | 3 |
| Pain - Bone | 0 | 0 | 5 |
| Pain - Cardiac/heart | 0 | 1 | 0 |
| Pain - Chest wall | 1 | 1 | 0 |
| Pain - Chest/thorax NOS | 0 | 1 | 1 |
| Pain - Extremity-limb | 1 | 0 | 0 |
| Pain - Head/headache | 2 | 2 | 0 |
| Pain - Joint | 1 | 0 | 1 |
| Pain - Muscle | 1 | 1 | 0 |
| Pain - Oral cavity | 1 | 0 | 0 |
| Pain - Skin | 0 | 1 | 0 |
| Pain - Stomach | 0 | 1 | 0 |
| Pain - Throat/pharynx/larynx | 0 | 0 | 1 |
| Pain - Tumor pain | 1 | 0 | 0 |
| Pain-Other (Specify) | 1 | 2 | 0 |
| Pancreatic endocrine: glucose intolerance | 1 | 1 | 0 |
| Phosphate, serum-low (hypophosphatemia) | 1 | 0 | 0 |
| Platelets | 1 | 0 | 34 |
| Pneumonitis/pulmonary infiltrates | 1 | 4 | 1 |
| Potassium, serum-high (hyperkalemia) | 0 | 0 | 1 |
| Potassium, serum-low (hypokalemia) | 0 | 0 | 4 |
| Rash/desquamation | 1 | 0 | 0 |
| Rigors/chills | 1 | 0 | 2 |
| Sodium, serum-low (hyponatremia) | 1 | 0 | 1 |
| Syncope (fainting) | 1 | 0 | 1 |
| Thrombosis/thrombus/embolism | 2 | 5 | 0 |
| Vomiting | 5 | 4 | 0 |
| Weight gain | 0 | 2 | 0 |
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \>1.5 cm or if both long and short axes are \> 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
| percentage of patients | HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap |
|---|---|
| Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. | 83 (46 to 95) |
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
| percentage of participants | HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap |
|---|---|
| Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. | 89 (43 to 98) |
Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
| Participants | PET-negative: Continued ABVD After 2 Cycles of ABVD | PET-positive: BEACOPP Standard After 2 Cycles of ABVD |
|---|---|---|
| Complete Response | 9 | 0 |
| Partial Response | 1 | 1 |
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
| Participants | Initial ABVD | PET-negative: Continued ABVD | PET-positive: BEACOPP Standard |
|---|---|---|---|
| Anorexia | 0 | 1 | 0 |
| Dizziness | 0 | 1 | 0 |
| Fatigue (asthenia, lethargy, malaise) | 1 | 1 | 0 |
| Febrile neutropenia | 3 | 3 | 0 |
| Hemoglobin | 1 | 3 | 1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS | 1 | 0 | 0 |
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 | 1 | 0 |
| Infection with unknown ANC - Urinary tract NOS | 0 | 0 | 1 |
| Insomnia | 1 | 0 | 0 |
| Leukocytes (total WBC) | 7 | 6 | 1 |
| Lymphopenia | 1 | 2 | 1 |
| Mood alteration - agitation | 1 | 0 | 0 |
| Mood alteration - anxiety | 1 | 0 | 0 |
| Muscle weakness, not d/t neuropathy - body/general | 1 | 0 | 0 |
| Neuropathy: motor | 0 | 1 | 0 |
| Neuropathy: sensory | 1 | 1 | 0 |
| Neutrophils/granulocytes (ANC/AGC) | 8 | 7 | 1 |
| Pain - Bone | 1 | 0 | 0 |
| Pain - Joint | 1 | 1 | 0 |
| Phosphate, serum-low (hypophosphatemia) | 1 | 1 | 0 |
| Platelets | 0 | 1 | 0 |
| Sodium, serum-low (hyponatremia) | 1 | 0 | 0 |
| Thrombosis/thrombus/embolism | 0 | 1 | 0 |
Collected over Up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIV-negative: Initial ABVD | — | 1/336 (0.3%) | 335/336 (99.7%) |
| HIV-negative and PET-negative: Continued ABVD | — | 6/270 (2.2%) | 268/270 (99.3%) |
| HIV-negative and PET-positive: BEACOPP Escalated | — | 2/49 (4.1%) | 49/49 (100%) |
| HIV-positive: Initial ABVD | — | 1/12 (8.3%) | 12/12 (100%) |
| HIV-positive and PET-negative: Continued ABVD | — | 0/10 (0%) | 9/10 (90%) |
| HIV-positive and PET-positive: BEACOPP Standard | — | 0/1 (0%) | 1/1 (100%) |
| Event | HIV-negative: Initial ABVD | HIV-negative and PET-negative: Continued ABVD | HIV-negative and PET-positive: BEACOPP Escalated | HIV-positive: Initial ABVD | HIV-positive and PET-negative: Continued ABVD | HIV-positive and PET-positive: BEACOPP Standard |
|---|---|---|---|---|---|---|
| Leukocytes (total WBC)Investigations | 0/336 | 0/270 | 0/49 | 1/12 | 0/10 | 0/1 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 0/336 | 1/270 | 0/49 | 1/12 | 0/10 | 0/1 |
| Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders | 0/336 | 0/270 | 0/49 | 1/12 | 0/10 | 0/1 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/336 | 0/270 | 1/49 | 0/12 | 0/10 | 0/1 |
| Inf (clin/microbio) w/Gr 3-4 neuts - BloodInfections and infestations | 0/336 | 0/270 | 1/49 | 0/12 | 0/10 | 0/1 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 0/336 | 0/270 | 1/49 | 0/12 | 0/10 | 0/1 |
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 0/336 | 1/270 | 1/49 | 0/12 | 0/10 | 0/1 |
| Thrombosis/thrombus/embolismVascular disorders | 0/336 | 2/270 | 0/49 | 0/12 | 0/10 | 0/1 |
| HemoglobinBlood and lymphatic system disorders | 0/336 | 1/270 | 0/49 | 0/12 | 0/10 | 0/1 |
| ColitisGastrointestinal disorders | 0/336 | 1/270 | 0/49 | 0/12 | 0/10 | 0/1 |
| Event | HIV-negative: Initial ABVD | HIV-negative and PET-negative: Continued ABVD | HIV-negative and PET-positive: BEACOPP Escalated | HIV-positive: Initial ABVD | HIV-positive and PET-negative: Continued ABVD | HIV-positive and PET-positive: BEACOPP Standard |
|---|---|---|---|---|---|---|
| HemoglobinBlood and lymphatic system disorders | 171/336 | 161/270 | 44/49 | 6/12 | 7/10 | 1/1 |
| Ocular/Visual-OtherEye disorders | 10/336 | 15/270 | 2/49 | 0/12 | 0/10 | 1/1 |
| Mucositis/stomatitis (clinical exam) - Oral cavityGastrointestinal disorders | 36/336 | 25/270 | 13/49 | 2/12 | 1/10 | 1/1 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 203/336 | 191/270 | 36/49 | 5/12 | 7/10 | 1/1 |
| Fever in absence of neutropenia, ANC lt1.0x10e9/LGeneral disorders | 24/336 | 35/270 | 10/49 | 1/12 | 3/10 | 1/1 |
| Rigors/chillsGeneral disorders | 20/336 | 17/270 | 11/49 | 2/12 | 4/10 | 1/1 |
| Infection with unknown ANC - Urinary tract NOSInfections and infestations | 1/336 | 1/270 | 0/49 | 0/12 | 0/10 | 1/1 |
| CreatinineInvestigations | 12/336 | 9/270 | 5/49 | 2/12 | 2/10 | 1/1 |
| Leukocytes (total WBC)Investigations | 212/336 | 188/270 | 45/49 | 7/12 | 6/10 | 1/1 |
| LymphopeniaInvestigations | 80/336 | 94/270 | 32/49 | 4/12 | 6/10 | 1/1 |
Only eligible and evaluable HIV-positive patients were included in the analysis.
| Age, Continuous(years) | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | Total |
|---|---|---|---|
| Median | 32.1 (18 to 60) | 44.6 (25 to 50) | 32.4 (18 to 60) |
| Sex: Female, Male(Participants) | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | Total |
|---|---|---|---|
| Female | 147 | 2 | 149 |
| Male | 189 | 10 | 199 |
| Ethnicity (NIH/OMB)(Participants) | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | Total |
|---|---|---|---|
| Hispanic or Latino | 28 | 3 | 31 |
| Not Hispanic or Latino | 273 | 8 | 281 |
| Unknown or Not Reported | 35 | 1 | 36 |
| Race (NIH/OMB)(Participants) | HIV-negative: Initial ABVD | HIV-positive: Initial ABVD | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 0 | 7 |
| Native Hawaiian or Other Pacific Islander | 3 | 0 | 3 |
| Black or African American | 32 | 4 | 36 |
| White | 274 | 5 | 279 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 17 | 3 | 20 |
Showing the first 100 of 423 sites.
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