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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003056




Registration number
NCT00003056
Ethics application status
Date submitted
1/11/1999
Date registered
24/05/2004
Date last updated
6/05/2021

Titles & IDs
Public title
Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation
Scientific title
Peripheral Blood Stem Cell Transplantation in Patients With Advanced Malignancies Eligible for Allogeneic Transplantation From Matched Related Donors: A Randomized Study of Cyclosporine/Methotrexate or Cyclosporine/T-Cell Depletion (CD34 Cell Selection) for GVHD Prophylaxis
Secondary ID [1] 0 0
MCV-CCHR-9703-2A
Secondary ID [2] 0 0
BAXTER-302302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Lymphoma 0 0
Graft Versus Host Disease 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
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclosporine
Treatment: Drugs - cyclosporine and methotrexate

Active Comparator: Unselected peripheral blood haemopoietic stem cells (PBSC) - Unselected PBSC together with control graft versus host disease (GVHD) prophylaxis - Control

Experimental: CD34+ cells isolated from PBSC - CD34+ cells isolated from PBSC using the Isolex 300i system together with cyclosporine


Treatment: Drugs: cyclosporine


Treatment: Drugs: cyclosporine and methotrexate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to neutrophil engraftment
Timepoint [1] 0 0
Month 1, post-transplant
Primary outcome [2] 0 0
Time to neutrophil engraftment
Timepoint [2] 0 0
Month 2, post-transplant
Primary outcome [3] 0 0
Time to neutrophil engraftment
Timepoint [3] 0 0
Month 3, post-transplant
Primary outcome [4] 0 0
Time to neutrophil engraftment
Timepoint [4] 0 0
Month 4, post-transplant
Primary outcome [5] 0 0
Time to neutrophil engraftment
Timepoint [5] 0 0
Month 5, post-transplant
Primary outcome [6] 0 0
Time to neutrophil engraftment
Timepoint [6] 0 0
Month 6, post-transplant

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: - Acute lymphocytic leukemia (ALL) with documented
chemosensitivity (complete response [CR], partial response [PR], or minor response [MR]) in
first or second remission, first or second relapse, or high risk ALL with Ph positive 9/22
translocation; OR - Acute myelogenous leukemia (AML) with documented chemosensitivity (CR,
PR, or MR) in first or second remission, or first or second relapse; OR - Chronic
myelogenous leukemia (CML), chronic or accelerated, that is not in blast crisis; OR -
Hodgkin's disease or non-Hodgkin's lymphoma with documented chemosensitivity in first or
second relapse Consenting human lymphocyte antigen (HLA)-identical related donor required
No active central nervous system (CNS) or skin leukemia involvement No disease that
requires additional mediastinal radiation

PATIENT CHARACTERISTICS: Age: 18-55 Performance status: Karnofsky 70-100% Life expectancy:
Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times
normal serum glutamate oxalo-acetate transaminase (SGOT) less than 2 times normal Renal:
Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at
rest at least 40% or within normal range Pulmonary: diffusing capacity of the lung for
carbon monoxide (DLCO) greater than 45% of predicted or within normal range Other: HIV
negative At least 2 weeks since any active infection requiring intravenous treatment with
antifungal, antibacterial or antiviral agents with the exception of coagulase negative
staphylococcal line infection No coexisting medical problems that would significantly
increase the risk of the transplant procedure Not pregnant or nursing

PRIOR CONCURRENT THERAPY: No more that 2 prior therapy regimens Biologic therapy: No prior
autologous or allogeneic bone marrow or peripheral blood stem cell transplant Chemotherapy:
Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy
subject to dose requirements Surgery: Not specified Other: At least 2 weeks since
intravenous treatment with antifungal, antibacterial or antiviral agents, except for
treatment of coagulase negative staphylococcal infection of an IV or central line
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Supportive Care
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2003
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Baxalta now part of Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were
destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the
transplanted cells can make an immune response against the body's normal tissues.

PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus
methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host
disease during peripheral stem cell transplantation in patients who have advanced leukemia or
lymphoma who are eligible for transplanted peripheral stem cells from a donor.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
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/ct2/show/NCT00003056