Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

NCT ID: NCT00861679

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSCT from matched family or unrelated donors(MD)

HSCT from matched family or unrelated donors(MD) to matched related donors.

Group Type: OTHER

Transplantation with Stem Cells from Umbilical Cord

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schneider Children's Medical Center of Israel

Petach Tikvah, , Israel

Countries

Israel

Other Identifiers

ALL-SCT-BFM-0321-08-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id