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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00078949




Registration number
NCT00078949
Ethics application status
Date submitted
8/03/2004
Date registered
9/03/2004

Titles & IDs
Public title
Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Scientific title
Phase III Study Of Gemcitabine, Dexamethasone, And Cisplatin Compared To Dexamethasone, Cytarabine, And Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] As Salvage Chemotherapy For Patients With Relapsed Or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior To Autologous Stem Cell Transplant And Followed By Maintenance Rituximab vs Observation
Secondary ID [1] 0 0
CAN-NCIC-LY12
Secondary ID [2] 0 0
LY12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - rituximab
Treatment: Drugs - cisplatin
Treatment: Drugs - cytarabine
Treatment: Drugs - dexamethasone
Treatment: Drugs - gemcitabine hydrochloride

Experimental: Salvage arm I - Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.

Experimental: Salvage arm II - Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.

Experimental: Maintenance arm I - Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.

No intervention: Maintenance arm II - Patients undergo observation only.


Treatment: Other: rituximab
Given IV

Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: cytarabine
Given IV

Treatment: Drugs: dexamethasone
Given IV

Treatment: Drugs: gemcitabine hydrochloride
Given IV
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response Rate of Patients After 2 Courses of Chemotherapy
Timepoint [1] 0 0
After 2 cycle of treatment
Primary outcome [2] 0 0
Transplantation Rate of Patients After 2 Courses of Chemotherapy
Timepoint [2] 0 0
During period 1 (salvage chemotherapy)
Primary outcome [3] 0 0
Event-free Survival of Patients on Maintenance Randomization (Period 2)
Timepoint [3] 0 0
during the period 2 (up to10 years)
Secondary outcome [1] 0 0
Toxic Effect
Timepoint [1] 0 0
48 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:

* Diffuse large cell lymphoma (includes primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma)
* Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue [MALT] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse

* Must be histologically confirmed
* No transformed lymphoma at diagnosis with subsequent indolent histology without transformation at relapse
* Peripheral T-cell lymphoma
* Anaplastic large cell lymphoma
* Small noncleaved Burkitt-like lymphoma
* T-cell or B-cell lineage confirmed by immunohistochemistry
* Clinically or radiologically documented disease meeting either of the following criteria:

* Measurable disease, defined as at least 1 bidimensionally measurable site of disease using clinical exam, CT scan, or MRI

* Lymph nodes must be > 1.5 cm by physical exam or CT scan
* Other non-nodal lesions must be = 1.0 cm by physical exam, CT scan, or MRI
* Bone lesions are not considered measurable
* Evaluable disease, defined as only nonmeasurable disease, including any of the following:

* Marrow infiltration
* Cytology-confirmed ascites or effusions
* Bony involvement
* Enlarged liver or spleen
* Unidimensionally measurable intrathoracic or abdominal masses
* Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, and gemcitabine
* No uncontrolled CNS involvement by lymphoma

* No CNS disease at time of relapse
* CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained

PATIENT CHARACTERISTICS:

Age

* 16 to 65

Performance status

* ECOG 0-3

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute granulocyte count = 1,000/mm^3
* Platelet count = 75,000/mm^3

Hepatic

* Bilirubin = 1.5 times upper limit of normal (ULN)
* AST or ALT = 2.5 times ULN (5 times ULN if liver involvement with lymphoma)
* Hepatitis B status known (for patients with a history of hepatitis B or who are at high risk of hepatitis B infection)

Renal

* Creatinine = 1.5 times ULN

Cardiovascular

* No significant cardiac dysfunction or cardiovascular disease

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to complete quality of life questionnaires
* HIV negative
* No active, uncontrolled bacterial, fungal, or viral infection
* No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No other concurrent serious illness or medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Chemotherapy
* Prior rituximab allowed

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior IV chemotherapy
* No prior high-dose chemotherapy with stem cell transplantation

Endocrine therapy

* No concurrent corticosteroids except for physiologic replacement

Radiotherapy

* At least 4 weeks since prior radiotherapy and recovered

* Exceptions may be made for low-dose, non-myelosuppressive radiotherapy
* No prior radiotherapy to more than 25% of functioning bone marrow
* Involved-field radiotherapy may be given to areas of bulky disease at relapse (= 5 cm) after stem cell transplantation, according to the center's policy

Surgery

* At least 2 weeks since prior major surgery

Other

* No other concurrent anticancer therapy
* No other concurrent experimental agents
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
849
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Manitoba
Country [8] 0 0
Canada
State/province [8] 0 0
New Brunswick
Country [9] 0 0
Canada
State/province [9] 0 0
Newfoundland and Labrador
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
NCIC Clinical Trials Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael R. Crump, MD, FRCPC
Address 0 0
Princess Margaret Hospital, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukr... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT00078949