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A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)
Anaplastic Large Cell Lymphoma

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Trial Information

A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma


I. Determine the efficacy of monoclonal antibody SGN-30 in combination with
cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients
with newly diagnosed anaplastic large cell lymphoma (ALCL).

II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.


I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.

II. Determine the response duration in patients treated with this regimen. III. Correlate
response with pretreatment serum CD30 levels. IV. Determine response to single-agent
monoclonal antibody SGN-30.

OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large
cell kinase (ALK) status (positive vs negative).

Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over
2 hours once weekly for 3 weeks.

Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of
monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over
2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour,
doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1
and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 5

Inclusion Criteria:

- Histologically or cytologically confirmed systemic anaplastic large cell lymphoma

- Tissue available for the determination of anaplastic large cell kinase (ALK) status
[t(2;5), ALK-NPM translocation] prior to study entry

- Prior steroids or topical treatments are allowed. Patients who are on chronic steroid
therapy may receive concomitant steroids provided they have been on a stable dosage
for at least 3 months prior to enrollment

- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1
dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or
as >= 10 mm by spiral CT scan

- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- WBC >= 3,000/mm³

- Absolute neutrophil count >= 1,500/mm³

- Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone
marrow involvement])

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- AST or ALT =< 2.5 times ULN

- Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60

- LVEF >= 50%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

Exclusion Criteria:

- No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in
largest diameter

- No primary cutaneous ALCL

- No known brain metastases

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to monoclonal antibody SGN-30

- No uncontrolled intercurrent illness, including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would preclude study compliance

- No prior or other concurrent malignancy with < 90% probability of survival at 5 years

- No other concurrent anticancer agents or therapies

- No prior chemotherapy for ALCL

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) defined as the proportion of patients experiencing a complete or partial response to a regimen of SGN-3- + CHOP

Outcome Description:

An ORR of 80% or higher would be evidence of sufficient activity to warrant further study of this treatment combination. Descriptive statistics will be used to report results.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Barbara Pro

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic



M D Anderson Cancer Center Houston, Texas  77030