Phase 2 N=296 Treatment

Therapy for Pediatric Hodgkin Lymphoma

Hodgkin Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00145600 ↗

Enrolled (actual)

296

Serious AEs

0.3%

Results posted

May 2013

Primary outcome: Primary: Event-free Survival Probability by Risk Group — 0.886; 0.844; 0.667; 0.793 probability of 5 yr. event free survival

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 12 Week Stanford V Chemotherapy (Drug); 4 cycles of VAMP chemotherapy (Drug); 2 alternating cycles of VAMP/COP chemotherapy (Drug); 3 alternating cycles of VAMP/COP chemotherapy (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: St. Jude Children's Research Hospital
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival Probability by Risk Group	0.886; 0.844; 0.667; 0.793	—
SECONDARY Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.	77.2; 73.9; 72.3; 65.4; 74.7; 66.5	0.3097
SECONDARY Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.	68.4; 62.3; 70.7; 64; 74.1; 65.7	<0.0001 sig
SECONDARY Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.	87.2; 83; 87.2; 81.4; 88.2; 82.2	0.0254 sig
SECONDARY Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.	69.6; 66.2; 67.2; 66.7; 69; 66.7	0.0687
SECONDARY Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.	75.7; 71.3; 75.1; 71.1; 77.5; 72.3	0.0014 sig
SECONDARY Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.	76.2; 72.4; 74.2; 69.3; 77; 70.6	0.0281 sig
SECONDARY Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.	67.7; 57.3; 69.4; 60.2; 83.4; 77	<0.0001 sig
SECONDARY Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.	60.7; 58.6; 59.7; 57.7; 75; 78.9	0.2758
SECONDARY Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.	71.3; 70.3; 73.8; 63.2; 78.5; 72.7	0.4263
SECONDARY Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.	84.1; 72.8; 82.8; 71.1; 82.1; 77.6	<0.0001 sig
SECONDARY Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.	64.5; 64.5; 64.7; 64.7; 67.1; 68.6	0.7192
SECONDARY Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.	77.6; 75.7; 78.9; 74.3; 80.8; 76.3	0.4807
SECONDARY Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.	77.5; 71.9; 77.6; 71.2; 78.4; 80.5	0.0157 sig
SECONDARY Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.	78.3; 73.6; 80.6; 74.9; 83.7; 83.1	0.0831
SECONDARY Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.	72.4; 68.3; 72.7; 67.6; 78.1; 77.6	0.0040 sig

Summary

With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

Eligibility Criteria

Inclusion Criteria

Eligible patients must have histologically confirmed previously untreated Hodgkin's disease (Patients receiving limited emergent RT or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
Patients must be 21 years of age or younger
Ann Arbor stages IIB-IV
No prior treatment.
No pregnant or lactating women.
Signed informed consent
If re-evaluation of a patient's disease shows favorable risk features or intermediate risk features, the patient will be removed from the HOD99 study and consented to the respective HOD08 or HOD05 study.

Inclusion: treatment of favorable risk features:

Ann Arbor IA or IIA with:
Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x ray)
Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)

Inclusion: unfavorable risk features:

Stage must be classified as one of the following:
Ann Arbor stage IIB, IIIB, or any IV

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00145600). 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.