NCT00142116 · REGISTRY CONDITION SEARCH

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-06-02

The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · NOT POSTED

To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.

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outcome · POSTED

Time to Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy * Baseline staging requirements * Absolute Neutrophil Count \> 500/microliter (uL) * Platelet Count \> 25,000/uL * Serum creatinine \< 2.5mg/dL * Total bilirubin and transaminase (SGOT) \< 2.5 X Upper Limit of Normal (ULN) * Greater than 18 years of age * Life expectancy of 3 months or greater * Eastern Cooperative Oncology Group (ECOG) status performance of 0-2 Exclusion Criteria: * Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry * Pregnant or lactating women * Serious co-morbid disease * Uncontrolled bacterial, fungal or viral infection * Active second malignancy
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
intervention Names
Drug: Thalidomide
Drug: Rituximab
label
Thalidomide and Rituximab
type
EXPERIMENTAL

interventions

arm Group Labels
Thalidomide and Rituximab
description
200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
name
Thalidomide
other Names
Thalomid
type
DRUG
arm Group Labels
Thalidomide and Rituximab
description
Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
name
Rituximab
other Names
Rituxan
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
measure
Objective Response Rate
time Frame
3 years
description
Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.
measure
Time to Progression
time Frame
49.1 months

secondary Outcomes

measure
To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.
time Frame
3 years

Full study description

brief Summary: The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.
detailed Description: * Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy. * During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response. * A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide. * If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum immunoglobulin M (IgM) levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study. * Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years. * Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.

Source references

references

citation
Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Briccetti FM, Pasmantier M, Zimbler H, Cooper RB, Moore M, Hill J 2nd, Rauch A, Garbo L, Chu L, Chua C, Nantel SH, Lovett DR, Boedeker H, Sonneborn H, Howard J, Musto P, Ciccarelli BT, Hatjiharissi E, Anderson KC. Thalidomide and rituximab in Waldenstrom macroglobulinemia. Blood. 2008 Dec 1;112(12):4452-7. doi: 10.1182/blood-2008-04-150854. Epub 2008 Aug 19.
pmid
18713945
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice