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Monoclonal Antibodies

Brentuximab + AVD Chemotherapy for Hodgkin's Lymphoma

N/A

Waitlist Available

Led By Anita Kumar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 and over

Ann Arbor Stage I or II disease

Must not have

Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease

Cardiac ejection fraction ≤ 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing 4 different Hodgkin Lymphoma treatments to see which is most effective while also limiting long-term side effects.

Who is the study for?

This trial is for adults over 18 with early stage, high-risk Hodgkin lymphoma. Participants must have FDG-avid and measurable disease, a specific size of lymph node mass, and agree to birth control if applicable. Excluded are those with certain blood counts, liver or kidney issues, pregnant or breastfeeding women, HIV/AIDS patients, individuals with peripheral neuropathy or on long-term steroids.

What is being tested?

The study tests Brentuximab Vedotin combined with AVD chemotherapy against three other treatment groups involving radiation therapy and interim PET scans. The goal is to cure more patients while reducing long-term side effects from treatments.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to Brentuximab Vedotin (like fever), nerve damage (neuropathy), fatigue from chemotherapy drugs like Doxorubicin HCL and Dacarbazine, as well as possible low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is in the early stages (Stage I or II).

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I have a lymph node mass larger than 7.0 cm.

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My Hodgkin lymphoma is CD30 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My total bilirubin level is 2.0 mg/dl or higher, and I don't have Gilbert's disease.

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My heart's pumping ability is reduced.

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My kidney function, measured by creatinine clearance, is less than 30 mL/min.

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My nerve damage does not severely affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

complete responses (all cohorts)

development of significant pulmonary toxicity

Secondary study objectives

Evaluate the prognostic significance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment5 Interventions

Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter \> 7.0 cm or coronal maximal diameter \> 7.0 cm. In this cohort. Pts will receive 4 cycles of brentuximab vedotin \& AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 \& 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin \& AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin \& AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck \& diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo.

Group II: Cohort 3Experimental Treatment6 Interventions

Group III: Cohort 2Experimental Treatment6 Interventions

Patients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter \> 7.0 cm OR coronal maximal diameter \> 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy.

Group IV: Cohort 1 (completed accrual)Experimental Treatment6 Interventions

Patients received 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinblastine Sulfate

2007

Completed Phase 4

~300

Dacarbazine

2005

Completed Phase 3

~5270