Childhood Acute Lymphoblastic Leukemia in RemissionPhase 3NCT00450450
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
A Phase 3 study testing allogeneic bone marrow transplantation, laboratory biomarker analysis and filgrastim in people with Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by Children's Oncology Group at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia
- What is being tested?
- allogeneic bone marrow transplantation, laboratory biomarker analysis and filgrastim
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 21 sitesUnited States
- Study dates
- 31 Dec 2007to 31 Mar 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 43Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Oncology Group
Arcadia, California, 91006-3776
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287-8936
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of North Carolina
Chapel Hill, North Carolina, 27599
Childrens Memorial Hospital
Chicago, Illinois, 60614
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Medical Center
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
The Childrens Mercy Hospital
Kansas City, Missouri, 64108
Kosair Children's Hospital
Louisville, Kentucky, 40202
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Medical Center
Salt Lake City, Utah, 84113
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
New York Medical College
Valhalla, New York, 10595
About this study
Official title: A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes
- Being tested
- allogeneic bone marrow transplantation, laboratory biomarker analysis, filgrastim
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelomonocytic, Juvenile, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic bone marrow transplantationProcedure or surgery
Also called bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow
Patients undergo allogeneic BMT
laboratory biomarker analysisOther
Correlative studies
filgrastimBiological
Also called Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0. Receives: Procedure: allogeneic bone marrow transplantation; Other: laboratory biomarker analysis; Biological: filgrastim |
| Arm II | Active comparator | Patients undergo conventional allogeneic bone marrow transplantation on day 0. Receives: Procedure: allogeneic bone marrow transplantation; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Two-year Event-free Survival (EFS)
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.
Measured: at 2 years
Secondary outcomes (6)
Estimated Graft Failure Rate
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.
Measured: Up to 10 years
Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)
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.
Measured: Up to 3 months
Estimated 100-day Transplant Related Mortality (TRM) Percentage
Death in a patient after transplant due to protocol treatment is defined as an TRM.
Measured: 100 days
Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)
cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
Measured: 18 months post-transplant
Estimated Median Time to Neutrophil Engraftment
Median Time from transplant to neutrophil engraftment
Measured: Up to 10 years
Estimated Median Length of Initial Hospitalization
Estimated and compared between randomization arms using the Wilcoxon rank-sum test.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study start31 Dec 2007
- Primary completion1 Jun 2013
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood Acute Lymphoblastic Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephan A. Grupp, MD PhD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450450
- Sponsor's protocol ID
- ASCT0631
- Other IDs
- NCI-2009-01069, COG-ASCT0631, COG-PBMTC-STC051, CDR0000532926, U10CA098543
- Status last verified
- Jun 2021
- First submitted
- 20 Mar 2007
- Last updated
- 28 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation
- ClinicalTrials.gov ID
- NCT00450450
- Acronym / sponsor ID
- ASCT0631
- Conditions
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Dec 2007 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: allogeneic bone marrow transplantation, Other: laboratory biomarker analysis, Biological: filgrastimPatients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0. |
| Arm II | Active comparator | Procedure: allogeneic bone marrow transplantation, Other: laboratory biomarker analysisPatients undergo conventional allogeneic bone marrow transplantation on day 0. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (43 listed)
- Diagnosis of hematologic cancer or other disease, including any of the following:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic bone marrow transplantationAlso: bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrowPatients undergo allogeneic BMT | Procedure or surgery | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
| filgrastimAlso: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, NeupogenGiven IV | Biological | Arm I |
Primary outcome
Estimated Two-year Event-free Survival (EFS)
Time frame: at 2 years
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.
6 secondary outcomes
Estimated Graft Failure Rate
Time frame: Up to 10 years
Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)
Time frame: Up to 3 months
Estimated 100-day Transplant Related Mortality (TRM) Percentage
Time frame: 100 days
Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)
Time frame: 18 months post-transplant
Estimated Median Time to Neutrophil Engraftment
Time frame: Up to 10 years
Estimated Median Length of Initial Hospitalization
Time frame: Up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan A. Grupp, MD PhD principal investigator
Children's Oncology Group
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing allogeneic bone marrow transplantation, laboratory biomarker analysis and filgrastim in people with Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by Children's Oncology Group at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Two-year Event-free Survival (EFS) (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.