Recruiting

Acute Leukemia

Sponsor:

Dutch Childhood Oncology Group

Code:

NCT00550992

Conditions

Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

anti-thymocyte globulin

asparaginase

busulfan

cyclophosphamide

cyclosporine

Study Details

Brief summary:

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer 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 cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.

PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.

Conditions

Leukemia

Study ID

NCT00550992

Start date

Jan, 2006

Status verified date

Feb, 2019

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:

  • Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
  • Newly diagnosed disease
  • Verified by morphology and confirmed by cytochemistry and immunophenotyping

  • Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"
  • Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:

  • Low-risk disease, defined as all MLL germline cases
  • Medium-risk disease, defined by 1 of the following criteria:

  • MLL status unknown
  • MLL rearranged AND age > 6 months
  • MLL rearranged AND age < 6 months AND WBC < 300 x 10\^9/L AND prednisone good response
  • High-risk disease, defined by MLL rearrangement AND meets the following criteria:

  • Age at diagnosis < 6 months (i.e., < 183 days)
  • WBC ≥ 300 x 10\^9/L AND/OR prednisone poor response
  • Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:

  • Donor meeting 1 of the following criteria:

  • HLA-identical sibling
  • Very well-matched related or unrelated donor
  • Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
  • Stem cell source

  • Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim \[G-CSF\]-stimulated donors OR cord blood

  • Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10\^7/kg recipient body weight \[BW\]) is cryopreserved
  • Must have ≥ 3 x 10\^8 NCs/kg BW OR 3 x 10\^6/kg BW CD34-positive cells available for transplantation
  • CNS or testicular leukemia at diagnosis allowed

Exclusion criteria:

  • Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL
  • Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
  • Relapsed ALL

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior systemic corticosteroids

  • Corticosteroids by aerosol are allowed

Study Design

Enrollment

445 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

anti-thymocyte globulin

asparaginase

busulfan

cyclophosphamide

cyclosporine

cytarabine

daunorubicin hydrochloride

etoposide

leucovorin calcium

melphalan

mercaptopurine

methotrexate

mitoxantrone hydrochloride

pegaspargase

prednisolone

prednisone

therapeutic hydrocortisone

thioguanine

vincristine sulfate

allogeneic bone marrow transplantation

allogeneic hematopoietic stem cell transplantation

umbilical cord blood transplantation

Primary outcome measure

  • Disease-free survival [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Children's Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Lewis B. Silverman, MD

617-632-5285

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Clinical Trials Office - St. Jude Children's Research Hospital

901-595-4644

M. D. Anderson Cancer Center at University of Texas

Recruiting

Houston, Texas, United States, 77030-4009

Contacts

Clinical Trials Office - M. D. Anderson Cancer Center at the U

713-792-3245

Children's Hospital and Regional Medical Center - Seattle

Recruiting

Seattle, Washington, United States, 98105

Contacts

Blythe Thomson, MD

206-987-2106

More Information

Sponsor

Dutch Childhood Oncology Group

Last update posted

Jul 30, 2019

Last verified

Feb, 2019

Keywords

  • untreated childhood acute lymphoblastic leukemia
  • T-cell childhood acute lymphoblastic leukemia
  • acute undifferentiated leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dutch Childhood Oncology Group on 2019-07-30.