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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00438958




Registration number
NCT00438958
Ethics application status
Date submitted
20/02/2007
Date registered
22/02/2007
Date last updated
5/03/2014

Titles & IDs
Public title
Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
Scientific title
A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
Secondary ID [1] 0 0
CBMTG-0601
Secondary ID [2] 0 0
CDR0000528289
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloproliferative Disorders 0 0
Graft Versus Host Disease 0 0
Leukemia 0 0
Lymphoma 0 0
Myelodysplastic Syndromes 0 0
Secondary Myelofibrosis 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
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Surgery - allogeneic bone marrow transplantation
Treatment: Surgery - peripheral blood stem cell transplantation

Active comparator: Arm I - Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.

Experimental: Arm II - Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.


Treatment: Other: filgrastim
Given on day 0.

Treatment: Surgery: allogeneic bone marrow transplantation
Given on day 0

Treatment: Surgery: peripheral blood stem cell transplantation
Given on day 0
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to neutrophil recovery
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Primary graft failure
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Quality of life
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Time to acute GVHD
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Time to chronic GVHD
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Chronic GVHD details
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Cost
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Detailed donor and patient self-reported outcomes
Timepoint [9] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Diagnosis of one of the following hematologic malignancies:

* Acute myeloid leukemia in first complete remission or second complete remission
* Chronic myeloid leukemia in chronic or accelerated phase
* Myelodysplasia, including any of the following:

* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts (RAEB) I
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:

* Indolent non-Hodgkin's lymphoma (NHL)
* Aggressive NHL
* Chronic lymphocytic leukemia
* Hodgkin's lymphoma
* Myelofibrosis
* Hematologic malignancy not otherwise specified
* HLA-matched sibling donor available meeting all of the following criteria:

* 6/6 HLA match

* HLA typing performed by serologic or DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
* Not identical twin with patient

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No cognitive, linguistic, or emotional difficulty that would preclude participation in the quality-of-life component of the study
* Able to communicate in English or French
* No HIV antibody positivity

PRIOR CONCURRENT THERAPY:

* Not specified
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Institute of Medical and Veterinary Science - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Washington
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Saudi Arabia
State/province [8] 0 0
Riyadh

Funding & Sponsors
Primary sponsor type
Other
Name
The Canadian Blood and Marrow Transplant Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow transplant using stem cells from a brother or sister that closely match the patient's stem cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. Giving methotrexate and cyclosporine before and after transplant may stop this from happening. It is not yet known whether a donor peripheral stem cell transplant is more effective than a donor bone marrow transplant in treating hematologic cancers or other diseases.

PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
Trial website
https://clinicaltrials.gov/study/NCT00438958
Trial related presentations / publications
Kariminia A, Ivison S, Ng B, Rozmus J, Sung S, Varshney A, Aljurf M, Lachance S, Walker I, Toze C, Lipton J, Lee SJ, Szer J, Doocey R, Lewis I, Smith C, Chaudhri N, Levings MK, Broady R, Devins G, Szwajcer D, Foley R, Mostafavi S, Pavletic S, Wall DA, Couban S, Panzarella T, Schultz KR. CD56bright natural killer regulatory cells in filgrastim primed donor blood or marrow products regulate chronic graft-versus-host disease: the Canadian Blood and Marrow Transplant Group randomized 0601 study results. Haematologica. 2017 Nov;102(11):1936-1946. doi: 10.3324/haematol.2017.170928. Epub 2017 Sep 21.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Couban, MD
Address 0 0
Cancer Care Nova Scotia
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00438958