Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

Acute Lymphoblastic Leukemia Clinical Trial

— ALL SCT BFM  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861679
• Other study ID #: ALL-SCT-BFM-0321-08-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: September 2014

Study information

• Verified date: March 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: September 2014
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• Transplantation with Stem Cells from Umbilical Cord
According to results from published experiences in children following suggestions are given: 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 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. 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. If many choices available ABO- major incompatibility should be avoided.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		11 years