Overview

This trial is active, not recruiting.

Condition lymphoblastic leukemia, acute, childhood;
Treatments vp16, tbi, vp16, atg, fludarabine, okt3, treosulfan, thiotepa, vp16, atg
Phase phase 3
Sponsor St. Anna Kinderkrebsforschung
Start date January 2007
End date September 2011
Trial size 405 participants
Trial identifier NCT01423500, EudraCT 2005-005106-23

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
vp16 Etoposid
patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
tbi Total body irradiation
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
(Other)
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
vp16, atg Etoposid, Antithymoglobuline
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
tbi total body irradiation
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
(Other)
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
fludarabine, okt3, treosulfan, thiotepa ATG: Antithymoglobuline
patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG fresenius 20mg/kg/d on day -3,-2,-1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4
vp16, atg VP16: Etoposid
patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
tbi TBI: total body irradiation
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions

Primary Outcomes

Measure
Event free survival
time frame: 10 years

Secondary Outcomes

Measure
number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD)
time frame: 10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
time frame: 10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
time frame: 10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
time frame: 10 years
occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT
time frame: 10 years

Eligibility Criteria

Male or female participants from 3 months up to 18 years old.

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.

Additional Information

Official title Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
Principal investigator Petr Sedlacek, Prof. MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by St. Anna Kinderkrebsforschung.