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Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International (ALL SCT BFM)

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ClinicalTrials.gov Identifier: NCT00861679
Recruitment Status : Unknown
Verified March 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : March 13, 2009
Last Update Posted : March 17, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Procedure: Transplantation with Stem Cells from Umbilical Cord Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy Protocol ALL SCT BFM International-Open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date : January 2007
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2014



Intervention Details:
  • Procedure: Transplantation with Stem Cells from Umbilical Cord

    According to results from published experiences in children following suggestions are given:

    1. Number of Cells:

      • Number of nucleated cells infused exceed 2,5x10*7/kg recipient BW or
      • Number of nucleated cells collected exceed 3x10*7/kg BW
      • Number of CD34+ cells infused exceed 2x10*5/kg Recipient BW
    2. GVHD-prophylaxis:

      • MSD: CSA 3 mg/kg as described in the protocol + Prednisolone 1 mg/kg (day O to day 15, then tapering until day 28)

      • UD: as above + additional immunosuppression according to local protocols; ATG might increase risk of infectious complication and might be replaced by other drugs according to local protocols.

    3. HLA-matching for unrelated CB: a matched UB is defined by 6/6 HLA matches (A, B antigenic medium resolution and DRB1 allelic) and allocate to the transplantation group "MD". Less than 6/6 HLA matches allocate the patient to the "MMD" group.
    4. If many choices available ABO- major incompatibility should be avoided.


Primary Outcome Measures :
  1. event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 11 years ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

  • age at time of initial diagnosis or relapse diagnosis, respectively

    ≤18 years

  • indication for allogeneic HSCT
  • complete remission (CR) is achieved before SCT
  • written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
  • no pregnancy
  • no secondary malignancy
  • no previous HSCT
  • HSCT is performed in a study participating centre.

Exclusion Criteria:

  • not signed inform consent of the parents (legal guardian)
  • pregnancy
  • secondary malignancy
  • previous HSCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861679


Contacts
Contact: Polina Y Stepensky, M.D. 972-2-6777408 polina@hadassah.org.il

Locations
Israel
Schneider Children's Medical Center of Israel Recruiting
Petach Tikvah, Israel, 49202
Contact: Jerry Stein, M.D.    972-(50)-4057148    stein@clalit.org.il   
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Polina Stepensky, M.D., Hadassah Medical Organisation
ClinicalTrials.gov Identifier: NCT00861679     History of Changes
Other Study ID Numbers: ALL-SCT-BFM-0321-08-HMO-CTIL
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009

Keywords provided by Hadassah Medical Organization:
HSCT
ALL
GvHD

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases