Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

Hannover Medical School (MHH)

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Biological: Hematopoietic stem cells from bone marrow or peripheral blood

Study type: Interventional

Funder types: Other

Identifiers

NCT00606723

AML SCT-BFM 2007

2007-004517-34 (EudraCT Number)

Details and patient eligibility

About

1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.

Full description

Target variables:

• Treatment response
• Event Free Survival
• Leukemia Free Survival
• Graft Versus Host Disease
• Regimen related toxicity

Enrollment: 154 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 0-21 years
• Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
• In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
• Written informed consent of patient, parents or legal guardians

Exclusion criteria

• Severe renal impairment (GFR < 30% predicted for age)
• Pregnant or lactating females
• Current participation in another clinical trial
• Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

1

Experimental group

Description:

Group I: Relapsed AML-patients with blast cell reduction to \<20% before the second course of induction therapy. These patients will receive conventional SCT. Group II: Patients with non response to frontline treatment of AML, patients with blast cells \<20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells \>=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA". Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor.

Treatment:

Biological: Hematopoietic stem cells from bone marrow or peripheral blood