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Alkylating agents

Chemotherapy + Radiotherapy for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Matthew Ehrhardt, MD, MS
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Low-Risk: IA, IIA (excluding patients with 'E' lesions or mediastinal bulk)
Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment
Awards & highlights

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.

Who is the study for?
This trial is for children and young adults up to age 25 with untreated CD30+ classical Hodgkin lymphoma. Eligible participants have various stages of the disease, adequate organ function, and no prior therapy for Hodgkin's except limited emergency treatments. They must be able to perform normal activities without significant breathing issues.Check my eligibility
What is being tested?
The study tests different chemotherapy combinations based on risk levels: low/intermediate-risk patients receive BEABOVP regimen; high-risk patients get AEPA and CAPDac regimens. Some may also need radiotherapy if their nodes don't respond well after two cycles of chemo.See study design
What are the potential side effects?
Potential side effects include reactions to medication infusions, blood cell count changes leading to increased infection risk or bleeding problems, nausea, vomiting, hair loss from chemotherapy drugs like doxorubicin and cyclophosphamide, nerve damage from brentuximab vedotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in an early stage without significant spread.
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I was diagnosed before my 22nd birthday.
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I agree to use effective birth control during the study.
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I was diagnosed before my 26th birthday.
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My cancer is at a high-risk stage (IIB, IIIB, IV).
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I am a woman who has started menstruating and I have a negative pregnancy test.
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My cancer is stage IA or IIA with specific complications or is stage IB or IIIA.
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My lymphoma is at any stage according to the Ann Arbor classification.
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My liver tests are within the normal range for my age.
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My kidney function is good based on tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate of adequate response
Secondary outcome measures
Event-free survival
Local failure rate
Number of adverse events in high-risk patients
+2 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
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%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Low-RiskExperimental Treatment10 Interventions
Participants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Group II: Intermediate-RiskExperimental Treatment10 Interventions
Participants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Group III: High-RiskExperimental Treatment9 Interventions
Participants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bendamustine
2012
Completed Phase 4
~1440
Etoposide
2010
Completed Phase 3
~2440
Doxorubicin
2012
Completed Phase 3
~7940
Bleomycin
2001
Completed Phase 3
~4960
Vincristine
2003
Completed Phase 4
~2910
Vinblastine
1998
Completed Phase 3
~5260
Prednisone
2014
Completed Phase 4
~2370
Filgrastim
2000
Completed Phase 3
~3670
Brentuximab Vedotin
2015
Completed Phase 4
~1070
Cyclophosphamide
1995
Completed Phase 3
~3770
DTIC
2005
Completed Phase 3
~2950
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,748 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
432 Previous Clinical Trials
5,307,678 Total Patients Enrolled
Teva Pharmaceuticals USAIndustry Sponsor
230 Previous Clinical Trials
187,958 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03755804 — Phase 2
Hodgkin's Lymphoma Research Study Groups: High-Risk, Low-Risk, Intermediate-Risk
Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03755804 — Phase 2
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03755804 — Phase 2
~78 spots leftby Jan 2027
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