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Classic Hodgkin LymphomaPhase 2NCT00654732

Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

A Phase 2 study testing Bleomycin, Dacarbazine and Doxorubicin Hydrochloride in people with Classic Hodgkin Lymphoma and Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, run by M.D. Anderson Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 17 years and older
What is being tested?
Bleomycin, Dacarbazine and Doxorubicin Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
4 sitesUnited States
Study dates
19 Mar 2008to 5 Sep 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV
  • International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >= 45 years of age, stage IV, albumin < 4, white blood cell count [WBC] >= 15, lymphocytes < 8% or < 600, hemoglobin [Hgb] < 10.5)
  • Must sign a consent form
  • Absolute neutrophil count (ANC) >= 1,500/microL
  • Platelet > 100,000/microL
  • Left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition (MUGA) scan or echocardiogram
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  • Serum creatinine < 2 mg/dl
  • Serum bilirubin < 2 mg/dl
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN)
  • Bi-dimensionally measurable disease

Who cannot join

  • Lymphocyte predominant Hodgkin's lymphoma
  • Known human immunodeficiency virus (HIV) infection
  • Pregnant women and women of child bearing age who are not practicing adequate contraception
  • Prior chemotherapy or radiation therapy
  • Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma
  • Active infection requiring treatment with intravenous therapy
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  • Presence of central nervous system (CNS) lymphoma
  • Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix)
  • Active hepatitis B or C infection

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score &gt; 2)

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the event free survival (EFS) following therapy with rituximab plus adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of > 2.

SECONDARY OBJECTIVES:

  1. To compare the effect of the two treatment arms on positron emission tomography (PET) scan results after 2 cycles of therapy.

II. To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive rituximab intravenously (IV) over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Participants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.

After completion of study treatment, participants are followed up every 3 months for the first year, every 4 months for the second year, every 6 months for years 3-5, and then annually thereafter.

Being tested
Bleomycin, Dacarbazine, Doxorubicin Hydrochloride, Rituximab, Vinblastine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BleomycinDrug

    Also called BLEO, BLM

    Given IV

  • DacarbazineDrug

    Also called 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine

    Given IV

  • Doxorubicin HydrochlorideDrug

    Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin

    Given IV

  • RituximabBiological

    Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody

    Given IV

  • VinblastineDrug

    Also called Vincaleucoblastine, VLB

    Given IV

Study groups in NCT00654732
Study groupRoleWhat they receive
Arm A (rituximab, combination chemotherapy)ExperimentalParticipants receive rituximab intravenously IV over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bleomycin; Drug: Dacarbazine; Drug: Doxorubicin Hydrochloride; Biological: Rituximab; Drug: Vinblastine
Arm B (combination chemotherapy)Active comparatorParticipants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.
Receives: Drug: Bleomycin; Drug: Dacarbazine; Drug: Doxorubicin Hydrochloride; Drug: Vinblastine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free Survival (EFS) Rate

    EFS will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.

    Measured: From the start of study treatment up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2008 (estimated)
  2. Study start19 Mar 2008
  3. Primary completion5 Sep 2018
  4. Study completion5 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00654732
Sponsor's protocol ID
2007-0144
Other IDs
NCI-2018-01855, 2007-0144, P30CA016672
Status last verified
Feb 2020
First submitted
3 Apr 2008
Last updated
28 Feb 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bleomycin, Dacarbazine and Doxorubicin Hydrochloride in people with Classic Hodgkin Lymphoma and Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, run by M.D. Anderson Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival (EFS) Rate (time frame: From the start of study treatment up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00654732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.

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