Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 405
- Locations
- 24
- Primary Endpoint
- Event free survival
Study Overview
Brief Summary
With this protocol the ALL-SCT BFM international study group wants
- to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
- to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors.
- 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 Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).
Detailed Description
Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect but treatment related mortality and morbidity remains a serious problem.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
- •indication for allogeneic hematopoietic stem cell transplantation(HSCT)
- •complete remission before hematopoietic stem cell transplantation (HSCT)
- •written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
- •no pregnancy
- •no secondary malignancy
- •no previous hematopoietic stem cell transplantation (HSCT)
- •hematopoietic stem cell transplantation (HSCT) is performed in a study participating centre.
Exclusion Criteria
- •age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
- •no indication for allogeneic HSCT
- •no complete remission before SCT
- •no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
- •pregnancy
- •secondary malignancy
- •previous HSCT
- •HSCT is not performed in a study participating centre.
Arms & Interventions
MSD - Matched Sibling Donor
patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
Intervention: VP16 (Drug)
MSD - Matched Sibling Donor
patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
Intervention: TBI (Radiation)
MD - Matched Donor
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Intervention: VP16, ATG (Drug)
MD - Matched Donor
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Intervention: TBI (Radiation)
MMD - Mismatched Donor
Patients with a MMD receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Intervention: Fludarabine, OKT3, Treosulfan, Thiotepa (Drug)
MMD - Mismatched Donor
Patients with a MMD receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Intervention: VP16, ATG (Drug)
MMD - Mismatched Donor
Patients with a MMD receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Intervention: TBI (Radiation)
Outcomes
Primary Outcomes
Event free survival
Time Frame: 10 years
Event-free and overall survival after allogeneic HSCT
Secondary Outcomes
- number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD)(10 years)
- occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT(10 years)
- occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT(10 years)
Investigators
Prof. Christina Peters
MD, PhD
Children's Cancer Research Institute, Austria