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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

Tracking Information
First Submitted Date  ICMJE March 12, 2009
First Posted Date  ICMJE March 13, 2009
Last Update Posted Date March 17, 2009
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00861679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE 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.
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 12, 2009)
552
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date September 2014
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00861679
Other Study ID Numbers  ICMJE ALL-SCT-BFM-0321-08-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Polina Stepensky, M.D., Hadassah Medical Organisation
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP