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

NCT00450450 | Completed Phase 3 Results DMC

• 6 other identifiers: ASCT0631NCI-2009-01069COG-ASCT0631COG-PBMTC-STC051CDR0000532926U10CA098543
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 21

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.

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; Juvenile Myelomonocytic Leukemia; Previously Treated Myelodysplastic Syndromes; Recurrent Childhood Acute Lymphoblastic Leukemia; Secondary Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  at 2 years

Secondary Outcomes (6)

• Estimated Graft Failure Rate

  Up to 10 years

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

  Up to 3 months

• Estimated 100-day Transplant Related Mortality (TRM) Percentage

  100 days

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

  18 months post-transplant

• Estimated Median Time to Neutrophil Engraftment

  Up to 10 years

Other Outcomes (2)

• Immune Reconstitution

  Up to 1 year

• Infused Nucleated and CD34+ Cell Doses

  Up to 10 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0.

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.

Procedure: allogeneic bone marrow transplantation; Other: laboratory biomarker analysis

Interventions

allogeneic bone marrow transplantation PROCEDURE

Patients undergo allogeneic BMT

Also known as: bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow

Arm I; Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

filgrastim BIOLOGICAL

Given IV

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Arm I

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (21)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

The Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Transplantation; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

ASCT0631 is closed to further patient entry as of 11/25/2011 due to poor accrual.

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Stephan A. Grupp, MD PhD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: December 31, 2007
• Primary Completion: June 1, 2013
• Study Completion: March 31, 2022
• Last Updated: April 28, 2022
• Results First Posted: May 9, 2017

Record last verified: 2021-06

Locations

US (21)