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Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma

Phase 2
18 Years
60 Years
Open (Enrolling)

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Trial Information

Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma



- To determine the progression-free survival (PFS) of patients with non-bulky stage I or
II Hodgkin lymphoma treated with ABVD alone or followed by escalated BEACOPP and
involved-field radiation therapy.

- To compare the PFS of patients who are PET positive versus PET negative after 2 courses
of ABVD.


- To evaluate the complete response rate in patients treated with these regimens.

- To determine the predictive value of semiquantitative evaluation of FDG/PET uptake
using various approaches at baseline, after 2 courses of AVBD, and at completion of

- To determine the predictive value of volumetric changes on CT scan after courses 2 and
4 of ABVD and compare with PET parameters with and without combination analyses
(PET+dedicated CT data).

- To compare the predictive value of metabolic parameters/changes both visual and
quantitative, IHP criteria, volumetric CT changes, molecular parameters, and
conventional parameters, including initial prognostic score.

- To assess whether elevated baseline serum soluble CD30 (sCD30), IL10, CCL17, and CCL22
correlate with clinical response and PFS.

- To assess whether persistent or recurrent elevated serial serum sCD30, IL10, CCL17, or
CCL22 correlate with relapse/progression or PET scan results.

- To confirm independently useful tissue biomarkers for risk stratification in patients
with non-bulky stage I and II Hodgkin lymphoma treated with these regimens.

- To compare mediastinal bulk on standing PA and lateral chest x-ray (> 0.33 maximum
chest diameter) with chest CT (mass > 10 cm).

OUTLINE: This is a multicenter study.

- ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5 minutes,
bleomycin sulfate IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine
IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses.
Patients then undergo PET scan. Patients achieving complete response (CR), partial
response (PR), or stable disease (SD) with a negative PET scan receive 2 additional
courses of ABVD chemotherapy in the absence of disease progression or unacceptable
toxicity. Patients achieving CR, PR, or SD with a positive PET scan proceed to
escalated BEACOPP chemotherapy.

- Escalated BEACOPP* chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5
minutes and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 45-60
minutes on days 1-3, oral procarbazine on days 1-7, oral prednisone on days 1-14, and
bleomycin sulfate IV and vincristine IV on day 8. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity. Within 4-6
weeks after completion of BEACOPP chemotherapy, patients undergo involved-field
radiotherapy (IFRT) 5 days a week for 3½ weeks.

NOTE: * HIV-positive patients receive standard BEACOPP instead of escalated BEACOPP.

Patients undergo fludeoxyglucose F^18 PET/CT scan at baseline, and within 8-10 days after
completion of chemotherapy. Patients also undergo additional PET/CT scans within 3-4 weeks
after completion of ABVD or within 12 weeks after completion of BEACOPP and IFRT. Patients
with a negative PET scan proceed to follow up. Patients with a positive PET scan undergo
biopsy**. Patients with a negative biopsy proceed to follow up, and patients with a positive
biopsy are treated at the discretion of the investigator.

NOTE: ** Patients for whom biopsy is neither clinically appropriate nor medically feasible
proceed to follow-up. Patients for whom biopsy is neither clinically indicated nor medically
appropriate undergo a repeat PET/CT scan after 3 months. If PET/CT scan remains positive,
patients undergo biopsy as above.

Patients may undergo blood sample collection for biomarker studies.

After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for 2-3 years, and then annually for a maximum of 5 years.

Inclusion Criteria


- Histologically confirmed* Hodgkin lymphoma

- Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor
Staging Classification system

- Subclassified according to the WHO modification of the Rye Classification

- "E" extension allowed provided all other criteria have been met NOTE: *Pathology
materials must be submitted within 60 days of study registration. Core-needle
biopsies are acceptable provided they contain adequate tissue for primary
diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple
specimens are available, submit the most recent.

- No nodular lymphocyte-predominant Hodgkin lymphoma

- No mediastinal mass > 0.33 maximum intrathoracic diameter by standing
postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in
its largest diameter

- Measurable disease by physical examination or imaging studies

- Any tumor mass measurable in two dimensions and > 1 cm (or 1.5 cm if 0.5 cm
slices are used, as in spiral CT scans) allowed

- Lesions that are considered intrinsically non-measurable include:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Lesions that are situated in a previously irradiated area


- Performance status 0-2

- ANC ≥ 1,000/μL

- Platelet count ≥ 100,000/μL

- Serum creatinine ≤ 2 mg/dL

- Bilirubin ≤ 2 mg/dL

- AST ≤ 2 times upper limit of normal

- LVEF normal by ECHO or MUGA

- DLCO ≥ 60% with no symptomatic pulmonary disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL

- Patients must not have multi-drug resistant HIV infections (i.e., concurrent
AIDS-defining conditions)

- An HIV test is required for patients with a history of IV drug abuse or any
behavior associated with an increased risk of HIVinfection

- No "currently active" second malignancy other than nonmelanoma skin cancers

- Patients are not considered to have a "currently active" malignancy provided
they have completed therapy and are considered by their physician to be at < 30%
risk of relapse


- See Disease Characteristics

- No prior chemotherapy or radiotherapy for Hodgkin lymphoma

- 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed
and will be considered the first course

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) at 36 months

Safety Issue:


Principal Investigator

David J. Straus, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • adult favorable prognosis Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult unfavorable prognosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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