Therapy for Pediatric Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

St. Jude Children's Research Hospital

ClinicalTrials.gov Identifier:

NCT00145600

First received: September 2, 2005

Last updated: March 25, 2013

Last verified: February 2013

History of Changes

Results First Received: February 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hodgkin Lymphoma
Interventions:	Drug: 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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
296 patients were enrolled from 5 institutions between March 2000 and May 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Favorable Risk	Ann Arbor stage IA or IIA with: Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray) < 3 nodal regions involved on the same side of the diaphragm No extranodal extension of disease
Intermediate Risk	Stage must be classified as one of the following: Ann Arbor stage IB and IIIA Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable Risk, Group 1	Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
Unfavorable Risk, Group 2	Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV

Participant Flow: Overall Study

	Favorable Risk	Intermediate Risk	Unfavorable Risk, Group 1	Unfavorable Risk, Group 2
STARTED	91	46	13	146
COMPLETED	83	36	8	130
NOT COMPLETED	8	10	5	16
Death	1	2	2	6
Ineligible	3	0	1	5
Lost to Follow-up	2	6	2	4
Noncompliance	1	0	0	0
Withdrawal by Subject	1	2	0	1

Baseline Characteristics

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Reporting Groups

	Description
Favorable Risk	Ann Arbor stage IA or IIA with: Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray) < 3 nodal regions involved on the same side of the diaphragm No extranodal extension of disease
Intermediate Risk	Stage must be classified as one of the following: Ann Arbor stage IB and IIIA Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable Risk, Group 1	Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
Unfavorable Risk, Group 2	Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV
Total	Total of all reporting groups

Baseline Measures

	Favorable Risk	Intermediate Risk	Unfavorable Risk, Group 1	Unfavorable Risk, Group 2	Total
Number of Participants [units: participants]	91	46	13	146	296
Age [units: participants]
<=18 years	84	36	11	122	253
Between 18 and 65 years	7	10	2	24	43
>=65 years	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	13.08 ± 3.91	15.35 ± 3.28	14.85 ± 3.21	15.06 ± 3.37	14.48 ± 3.63
Gender [units: participants]
Female	32	26	5	80	143
Male	59	20	8	66	153

Outcome Measures

1. Primary:

Event-free Survival Probability by Risk Group [ Time Frame: Median 6.4 year follow-up ]

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2. Secondary:

Patient Quality of Life (QoL) [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy. ]