ALL-SCT BFM International- HSCT in Children and Adolescents With ALL (ALL-SCT-BFMi)

St. Anna Kinderkrebsforschung

Status and phase: Unknown; Phase 3

Conditions: Lymphoblastic Leukemia, Acute, Childhood;

Treatments: Drug: VP16; Drug: Fludarabine, OKT3, Treosulfan, Thiotepa; Radiation: TBI; Drug: VP16, ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT01423500

EudraCT 2005-005106-23

Details and patient eligibility

About

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).

Full 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.

Enrollment: 405 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 3 patient groups

MSD - Matched Sibling Donor

Other group

Description:

patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)

Treatment:

Radiation: TBI

Radiation: TBI

Radiation: TBI

Drug: VP16

MD - Matched Donor

Other group

Description:

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

Treatment:

Radiation: TBI

Radiation: TBI

Drug: VP16, ATG

Radiation: TBI

Drug: VP16, ATG

MMD - Mismatched Donor

Other group

Description:

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

Treatment:

Radiation: TBI

Radiation: TBI

Drug: VP16, ATG

Drug: Fludarabine, OKT3, Treosulfan, Thiotepa

Radiation: TBI

Drug: VP16, ATG