Phase 2
N=80
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00352027 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Oct 2016
Primary outcome: Primary: 3-year Event-Free Survival Probability — 0.887 probability — p=0.9970
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adriamycin® (Drug); Vinblastine (Drug); Nitrogen Mustard (Drug); Cyclophosphamide (Drug); Vincristine (Drug); Bleomycin (Drug); Etoposide (Drug); Prednisone (Drug); G-CSF (Biological); Radiotherapy (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-year Event-Free Survival Probability |
0.887 | 0.9970 |
| SECONDARY Disease Failure Rate Within Radiation Fields |
0.1125 | — |
| SECONDARY Local and Distant Failure for Children Treated With Tailored-field Radiation |
0.0375; 0.1127 | — |
| SECONDARY Prognostic Factors for Treatment Failure: Age |
11 | 0.9970 |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.4.0: Total Score |
80.9; 74.4; 75.3; 83.1; 84.5 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning |
83.2; 68.4; 69.1; 80.8; 85.2 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
79.3; 77.6; 78.6; 84.3; 84.3 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
72.6; 75.3; 75.7; 84.5; 81.6 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning |
90.9; 88.6; 88.0; 90.1; 91.1 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning |
73.1; 69.5; 72.6; 78.4; 81.3 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Total Score |
74.1; 74.2; 81.7; 83.5 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
63.9; 71.5; 79.9; 88.0 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Nausea |
62.7; 60.1; 76.7; 81.6 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
71.8; 70.9; 68.1; 80.1 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
89.2; 82; 89.4; 87.3 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Worry |
71.2; 72.2; 74.5; 76.0 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
79.1; 78.2; 87.0; 82.0 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
77.6; 81.3; 81.4; 84.7 | — |
| SECONDARY Patient Quality of Life (QoL), PedsQL v.3.0: Communication |
80.7; 83.0; 87.2; 89.0 | — |
| SECONDARY Patient Quality of Life (QoL), Symptom Distress Scale |
17.3; 19.6; 18.1; 15.1; 14.3 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score |
77.6; 69.1; 72.3; 77.8; 83.5 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning |
79.8; 65.3; 67.3; 73.6; 84.6 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health |
76.2; 71.0; 74.1; 79.0; 88.0 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning |
67.7; 65.4; 68.1; 73.0; 82.0 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning |
86.1; 83.0; 80.7; 85.1; 89.1 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning |
74.4; 62.8; 70.8; 75.6; 78.9 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score |
71.7; 69.3; 74.5; 80.0 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt |
61.2; 61.8; 73.1; 82.7 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea |
61.2; 57.4; 72.2; 83.2 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety |
70.0; 60.0; 63.1; 73.8 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety |
81.9; 72.6; 78.5; 81.8 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry |
70; 69.2; 71.9; 78.7 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems |
77.6; 79.5; 78.6; 79.9 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance |
74.9; 72.2; 73.7; 76.3 | — |
| SECONDARY Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication |
79.2; 80.4; 80.3; 84.3 | — |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score |
-2.9; -4.8; -4.8; -5; -2.9 | 0.265 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning |
-2.9; -2.3; -1.9; -5.4; -2 | 0.563 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health |
-2.8; -6.4; -6.3; -5.6; -3.3 | 0.319 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning |
-4.9; -9.4; -8.0; -10.8; -1.7 | 0.071 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning |
-5.3; -5.7; -7.4; -5.0; -3.3 | 0.042 sig |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning |
1.3; -5.3; -4.1; -3.4; -4.3 | 0.546 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score |
-1.5; -5.2; -4.5; -5 | 0.558 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt |
-2.0; -9.5; -5.6; -5.4 | 0.381 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea |
-1.2; -3.4; -3.0; -1.1 | 0.629 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety |
-0.2; -9.3; -2.2; -8.7 | 0.744 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety |
-6.1; -8.8; -7.9; -6.6 | 0.078 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry |
-0.7; -3.9; -2.7; -0.5 | 0.739 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems |
-1.0; 0.14; -8.0; -4.0 | 0.933 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance |
-2.5; -9.5; -5.9; -9.3 | 0.415 |
| SECONDARY Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication |
-0.3; -3.6; -7.4; -6.3 | 0.814 |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score |
-1.46 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning |
-1.9 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health |
-0.92 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning |
-1.56 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning |
-0.79 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning |
-1.21 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score |
-1.41 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt |
-2.52 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea |
-2.31 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety |
-0.87 | 0.005 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety |
-0.96 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry |
-1.06 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems |
-1.46 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance |
-1.20 | <0.001 sig |
| SECONDARY Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication |
-1.35 | <0.001 sig |
| SECONDARY 3-year Event-free Survival (EFS) Probability |
0.887; 0.844 | 0.908 |
| SECONDARY 3-year Overall Survival (OS) Probability |
1.00; 0.978 | 0.178 |
| SECONDARY 3-year Local Failure-free Survival Probability |
0.887; 0.932 | 0.411 |
| SECONDARY Toxicities With Grade >1 |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Prognostic Factors for Treatment Failure: Gender |
5; 6 | 0.4318 |
| SECONDARY Prognostic Factors for Treatment Failure: Histology |
10; 1 | 0.2199 |
| SECONDARY Prognostic Factors for Treatment Failure: Stage |
8; 3 | 0.8946 |
| SECONDARY Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) |
68; 57; 36; 15; 0; 1 | — |
| SECONDARY Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) |
51; 44; 24; 10; 5; 8 | — |
| SECONDARY Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) |
46; 41; 25; 9; 20; 20 | — |
| SECONDARY Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) |
60; 54; 37; 20; 8; 11 | — |
Summary
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.
Eligibility Criteria
Inclusion Criteria
- Patient is less than or equal to 21 years of age
- Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
- Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.
Exclusion Criteria
- Patients with favorable risk features
- Patients with unfavorable risk features
- Patients who have received prior therapy for Hodgkin lymphoma.
Data sourced from ClinicalTrials.gov (NCT00352027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.