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

Hadassah Medical Center

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Transplantation with Stem Cells from Umbilical Cord

Study type: Interventional

Funder types: Other

Identifiers

NCT00861679

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

Details and patient eligibility

About

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.

Enrollment: 552 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

552 participants in 1 patient group

HSCT from matched family or unrelated donors(MD)

Other group

Description:

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

Treatment:

Procedure: Transplantation with Stem Cells from Umbilical Cord