NCT00450450 · REGISTRY CONDITION SEARCH

Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases

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

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2022-04-28

This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant 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. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Estimated Two-year Event-free Survival (EFS)

→

outcome · POSTED

Estimated Graft Failure Rate

→

outcome · POSTED

Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)

→

outcome · POSTED

Estimated 100-day Transplant Related Mortality (TRM) Percentage

→

outcome · POSTED

Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)

→

outcome · POSTED

Estimated Median Time to Neutrophil Engraftment

→

outcome · POSTED

Estimated Median Length of Initial Hospitalization

→

outcome · POSTED

Immune Reconstitution

→

outcome · POSTED

Infused Nucleated and CD34+ Cell Doses

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of hematologic cancer or other disease, including any of the following: * Chronic myelogenous leukemia in first or second chronic phase * Acute lymphoblastic leukemia (ALL), meeting any of the following criteria: * Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received ≥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks) * ALL in second complete remission (CR)\* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse * Very high-risk ALL in first CR, defined as any of the following: * Philadelphia chromosome-positive ALL * Hypodiploidy (\< 44 chromosomes) * Mixed lineage leukemia rearrangement * Induction failure * Acute myeloid leukemia in first or second CR * Induction therapy must be completed * Juvenile myelomonocytic leukemia * Myelodysplastic syndromes * No clinically evident CNS or extramedullary disease * No blasts seen on cerebrospinal fluid cytospin * Post-relapse reinduction therapy must be completed * Not planning to receive reduced-intensity conditioning regimen * Not planning to receive a graft that has undergone T-cell depletion * No Down syndrome * Matched sibling donor must be available and must be enrolled on ASCT0631D companion study * Karnofsky performance status (PS) 60-100% (patients \> 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years of age) * AST or ALT \< 5 times upper limit of normal for age * Bilirubin \< 2.5 mg/dL (unless due to Gilbert's syndrome) * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine base on age and/or gender as follows: * 0.4 mg/dL (1 month to \< 6 months of age) * 0.5 mg/dL (6 months to \< 1 year of age) * 0.6 mg/dL (1 to 2 years of age) * 0.8 mg/dL (2 to \< 6 years of age) * 1.0 mg/dL (6 to \< 10 years of age) * 1.2 mg/dL (10 to \< 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age) * Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram * FEV\_1, FVC, and DLCO ≥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests): * No evidence of dyspnea at rest * No exercise intolerance * No requirement for supplemental oxygen therapy * Not pregnant or nursing * No known HIV * No known uncontrolled fungal, bacterial, or viral infections * Patients acquiring fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT scan * No prior allogeneic or autologous stem cell transplantation
healthy Volunteers: false
maximum Age: 21 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0.
intervention Names
Procedure: allogeneic bone marrow transplantation
Other: laboratory biomarker analysis
Biological: filgrastim
label
Arm I
type
EXPERIMENTAL
description
Patients undergo conventional allogeneic bone marrow transplantation on day 0.
intervention Names
Procedure: allogeneic bone marrow transplantation
Other: laboratory biomarker analysis
label
Arm II
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm I
Arm II
description
Patients undergo allogeneic BMT
name
allogeneic bone marrow transplantation
other Names
bone marrow therapy, allogeneic
bone marrow therapy, allogenic
transplantation, allogeneic bone marrow
transplantation, allogenic bone marrow
type
PROCEDURE
arm Group Labels
Arm I
Arm II
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER
arm Group Labels
Arm I
description
Given IV
name
filgrastim
other Names
Granulocyte Colony-Stimulating Factor
r-metHuG-CSF
G-CSF
Neupogen
NSC #614629
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 27
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.
measure
Immune Reconstitution
time Frame
Up to 1 year
description
Compared using the Wilcoxon rank-sum test.
measure
Infused Nucleated and CD34+ Cell Doses
time Frame
Up to 10 years

primary Outcomes

description
EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
measure
Estimated Two-year Event-free Survival (EFS)
time Frame
at 2 years

secondary Outcomes

description
Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.
measure
Estimated Graft Failure Rate
time Frame
Up to 10 years
description
Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.
measure
Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)
time Frame
Up to 3 months
description
Death in a patient after transplant due to protocol treatment is defined as an TRM.
measure
Estimated 100-day Transplant Related Mortality (TRM) Percentage
time Frame
100 days
description
cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
measure
Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)
time Frame
18 months post-transplant
description
Median Time from transplant to neutrophil engraftment
measure
Estimated Median Time to Neutrophil Engraftment
time Frame
Up to 10 years
description
Estimated and compared between randomization arms using the Wilcoxon rank-sum test.
measure
Estimated Median Length of Initial Hospitalization
time Frame
Up to 10 years

Full study description

brief Summary: This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant 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. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.
detailed Description: PRIMARY OBJECTIVE: I. Compare improvement in event-free survival of patients with hematologic cancer or other diseases undergoing filgrastim (G-CSF)-stimulated bone marrow transplantation (BMT) vs conventional BMT. SECONDARY OBJECTIVES: I. Compare the incidence and time to engraftment in patients treated with these regimens. II. Compare rates of acute and chronic graft-vs-host disease (GVHD) in patients treated with these regimens. III. Correlate incidence of acute and chronic GVHD with absolute T-cell numbers, Th1 vs Th2 profile of T cells, dendritic cell populations, and T-regulatory cell content. IV. Assess the impact of G-CSF-stimulated BMT as a stem cell source on hospital stay and treatment-related mortality at day 100 in patients treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk (high vs intermediate vs standard). CONDITIONING REGIMEN: Co-enrolled on COG-ASCT0431 or COG-AAML0531; Patients receive a conditioning regimen as defined on that treatment study. ACUTE LYMPHOBLASTIC LEUKEMIA (ALL): Patients undergo total-body irradiation (TBI) twice daily on days -8 to -6. Patients receive thiotepa IV on days -5 and -4 and high-dose cyclophosphamide IV over 1 hour on days -3 and -2. Some patients with CNS leukemia or very high-risk ALL in first complete remission receive cranial radiotherapy. ACUTE MYELOID LEUKEMIA, JUVENILE MYELOMONOCYTIC, CHRONIC MYELOGENOUS LEUKEMIA, OR MYELODYSPLASTIC SYNDROMES: (myeloid malignancies) Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -6 and high-dose cyclophosphamide IV over 1 hour on days -5 to -2. GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Co-enrolled on COG-ASCT0431 or COG-AAML0531: Patients undergo GVHD prophylaxis as defined on that treatment study. ALL: Patients receive tacrolimus IV or orally beginning on day -2 and continuing until day 42, followed by a taper until day 98. Patients also receive methotrexate IV on days 1, 3, and 6. MYELOID MALIGNANCIES: Patients receive cyclosporine IV continuously or orally beginning on day -1 and continuing until day 42 or day 50, followed by a taper for 8-16 weeks. Patients also receive methotrexate IV on days 1, 3, 6, and 11. ALLOGENEIC BONE MARROW TRANSPLANTATION (BMT): Patients are randomized to 1 of 2 transplantation arms. ARM I: Patients undergo filgrastim (G-CSF) -stimulated allogeneic BMT on day 0. ARM II: Patients undergo conventional allogeneic BMT on day 0. After completion of study treatment, patients are followed at 1 year and then annually for 5-10 years.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-042680a366084da167bf
requested nct id
NCT00450450
primary nct id
NCT00450450
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Myelodysplastic+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
payload sha256
9b9d33fb6818fb67741911a1be215e4fbe2131b918bb20028481b80128db345c
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-042680a366084da167bf
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00450450
occurrences
context exact
NCT00450450
end
11
exact text
NCT00450450
start
0
offset unit
unicode_code_points
query cond
Childhood Myelodysplastic Neoplasms
query disease state id
ds-myelodysplastic-neoplasms-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-myelodysplastic-neoplasms-000.json
source file sha256
a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
source json pointer
/studies/39/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
91cbec7223163e027ad877f4364248bc8d6a6562b7f52c347ddbb7b1c0edc253
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Myelodysplastic+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-1cabfae73f39a5a64e83
requested nct id
NCT00450450
primary nct id
NCT00450450
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
payload sha256
beb70b77e185d4ef46c8e91bcc8db52248cb596812d0bd3b719725d367b0beb7
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-1cabfae73f39a5a64e83
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00450450
occurrences
context exact
NCT00450450
end
11
exact text
NCT00450450
start
0
offset unit
unicode_code_points
query cond
Juvenile Myelomonocytic Leukemia
query disease state id
ds-juvenile-myelomonocytic-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
source json pointer
/studies/90/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
91cbec7223163e027ad877f4364248bc8d6a6562b7f52c347ddbb7b1c0edc253
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-456ee322846b0444c1d6
requested nct id
NCT00450450
primary nct id
NCT00450450
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Chronic+Myeloid+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
payload sha256
19d86597bccb94b6ec66d352b83ca640ec7f847d89fc8ebac3b8962b179af06c
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-456ee322846b0444c1d6
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00450450
occurrences
context exact
NCT00450450
end
11
exact text
NCT00450450
start
0
offset unit
unicode_code_points
query cond
Childhood Chronic Myeloid Leukemia
query disease state id
ds-chronic-myeloid-leukemia-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-chronic-myeloid-leukemia-000.json
source file sha256
193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
source json pointer
/studies/35/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
91cbec7223163e027ad877f4364248bc8d6a6562b7f52c347ddbb7b1c0edc253
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Chronic+Myeloid+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice