Radiotherapy for Hodgkin's Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hodgkin's LymphomaRadiotherapy - Radiation
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is using different chemotherapy regimens for low, intermediate, and high risk classical Hodgkin lymphoma patients. Two cycles of therapy will be given, and if there is no adequate response, radiotherapy will be given.

Eligible Conditions
  • Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

Month 8
Number of adverse events in high-risk patients
Number of adverse events in low-risk and intermediate-risk patients
Year 3
Event-free survival
Local failure rate
Month 2
Response rate
Response rate of adequate response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Arm B (Stanford V)
98%Anemia
93%Leukocytes decreased
90%Lymphopenia
84%Neutrophils decreased
78%Neuropathy-sensory
75%Alopecia
74%Fatigue
67%Nausea
60%Hyperglycemia
52%Constipation
46%Hypoalbuminemia
40%Myalgia
34%Stomatitis
33%Insomnia
32%Vomiting
27%Platelets decreased
26%Alkaline phosphatase increased
26%Aspartate aminotransferase increased
23%Dyspnea
20%Dyspepsia
19%Dysphagia
19%Headache
16%Arthralgia
16%Anorexia
15%Abdominal pain
15%Neuropathy-motor
14%Cough
14%Fever
14%Infection w/o neutropenia
13%Diarrhea w/o prior colostomy
13%Rash/desquamation
12%Bone pain
11%Weight gain
11%Taste disturbance
11%Anxiety/agitation
10%Sweating
10%Radiation dermatitis
9%Dizziness/lightheadedness
9%Rigors/chills
9%Injection site reaction
8%Pain-other
8%Phlebitis
8%Chest pain
8%Blood bilirubin increased
8%Dysphagia-esophageal radiation
8%Hypoglycemia
7%Pruritus
7%Edema
7%Creatinine increased
6%Infection w/ grade 3 or 4 neutropenia
6%Hot flashes
6%Weight loss
5%Mouth dryness
5%Depression
5%Muscle weakness
4%Pneumonitis/pulmonary infiltrates
4%Transfusion: pRBCs
3%Irregular menses
3%Febrile neutropenia
3%Nail changes
3%Thrombosis/embolism
2%Allergic rhinitis
1%Syncope
1%Sinus tachycardia
1%Infection w/ unknown ANC
1%Neuropathic pain
1%Allergic reaction
1%Dehydration
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm B (Stanford V) ARM group. Side effects include: Anemia with 98%, Leukocytes decreased with 93%, Lymphopenia with 90%, Neutrophils decreased with 84%, Neuropathy-sensory with 78%.

Trial Design

3 Treatment Groups

Low-Risk
1 of 3
Intermediate-Risk
1 of 3
High-Risk
1 of 3

Experimental Treatment

250 Total Participants · 3 Treatment Groups

Primary Treatment: Radiotherapy · No Placebo Group · Phase 2

Low-RiskExperimental Group · 10 Interventions: Vincristine, Radiotherapy, bendamustine, Etoposide, Bleomycin, Doxorubicin, Vinblastine, Quality of Life Measurements, Filgrastim, Prednisone · Intervention Types: Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug
Intermediate-RiskExperimental Group · 10 Interventions: Vincristine, Radiotherapy, bendamustine, Etoposide, Bleomycin, Doxorubicin, Vinblastine, Quality of Life Measurements, Filgrastim, Prednisone · Intervention Types: Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug
High-RiskExperimental Group · 9 Interventions: Cyclophosphamide, Radiotherapy, Etoposide, Doxorubicin, Quality of Life Measurements, Brentuximab Vedotin, Filgrastim, Prednisone, DTIC · Intervention Types: Drug, Radiation, Drug, Drug, Other, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Radiotherapy
2017
Completed Phase 3
~2600
Bendamustine
FDA approved
Etoposide
FDA approved
Bleomycin
FDA approved
Doxorubicin
FDA approved
Vinblastine
FDA approved
Brentuximab vedotin
FDA approved
Filgrastim
FDA approved
Prednisolone
FDA approved
Dacarbazine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

Who is running the clinical trial?

Seagen Inc.Industry Sponsor
185 Previous Clinical Trials
61,329 Total Patients Enrolled
Teva Pharmaceuticals USAIndustry Sponsor
227 Previous Clinical Trials
182,365 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
401 Previous Clinical Trials
5,301,056 Total Patients Enrolled
Jamie Flerlage, MD, MSPrincipal InvestigatorSt. Jude Children's Research Hospital

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have adequate hepatic function.
All Ann Arbor stages.\n
The hematologic criteria are adequate at baseline.