Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00606723|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2008
Last Update Posted : May 13, 2020
- 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).
- To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
- To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Biological: Hematopoietic stem cells from bone marrow or peripheral blood||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
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.
Biological: Hematopoietic stem cells from bone marrow or peripheral blood
> = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.
- To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2). [ Time Frame: day 100 ]
- To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group [ Time Frame: day 100 ]
- To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls. [ Time Frame: day 100 ]
- Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD [ Time Frame: day 100 ]
- To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network [ Time Frame: day 100 ]
- Decrease of transplantation associated mortality by standardized donor selection criteria [ Time Frame: day 100 ]
- To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML [ Time Frame: day 100 ]
- Prospective evaluation of late toxicities [ Time Frame: day 100 and year 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606723
|Principal Investigator:||Martin Sauer, Prof. Dr.||Hannover Medical School|